PEDSnet Report Details How COVID-19 Pandemic Has Affected Children

Analysis of 135,000+ medical records shows the novel coronavirus hits hardest among teens, children with diabetes or cancer, lower-income families, and Black, Latin and Asian groups. In the most comprehensive analysis to date of U.S. children tested and treated for COVID-19, an organization representing seven of the nation’s largest pediatric medical centers reports that some

Read More


Big Data Powers Design of ‘Smart’ Cell Therapies for Cancer

Combining Machine Learning with Cell Engineering, Scientists Can Design ‘Living Medicines’ that Precisely Target Tumors Finding medicines that can kill cancer cells while leaving normal tissue unscathed is a Holy Grail of oncology research. In two new papers, scientists at UC San Francisco and Princeton University present complementary strategies to crack this problem with “smart”

Read More


CAR T-Cell Research is surging accompanied by a diversification of development and manufacturing pathways.

Hundreds of trials are under way, 3 CAR T-cell therapies for hematologic malignancies are on the market, and 2 new products may receive FDA approval in the next several months, including a BCMA–directed therapy that is poised to help transform treatment of multiple myeloma Research on chimeric antigen receptor (CAR) T-cell therapies has exploded since

Read More


A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia fails to shows significant clinical benefit as compared with placebo.

Convalescent plasma is frequently administered to patients with Covid-19 and has been reported, largely on the basis of observational data, to improve clinical outcomes. Minimal data are available from adequately powered randomized, controlled trials. In this paper researchers of the Clinical Pharmacology Section, Hospital Italiano de Buenos Aires, Juan D. Perón, Buenos Aires, Argentina as

Read More


Drug guides stem cells to desired location, improving their ability to heal

Discovery represents a major milestone for regenerative medicine that could help more people benefit from stem cell therapy. Scientists at Sanford Burnham Prebys Medical Discovery Institute have created a drug that can lure stem cells to damaged tissue and improve treatment efficacy—a scientific first and a major advance for the field of regenerative medicine. The

Read More


Most Americans are still vulnerable to SARS-CoV-2 virus. Seroprevalence over 4 collection periods ranged from less than 1% to 23%

As of September, the vast majority of Americans did not have coronavirus antibodies, according to a new study published in JAMA Internal Medicine. These data matter as the coronavirus spreads rapidly throughout most of the country, most people remain vulnerable to it. Across the U.S., the portion of states’ populations with detectable antibodies ranged from less

Read More


Insulin treatment is associated with increased mortality in patients with COVID-19

COVID-19 caused by SARS-COV2 infection can lead to multi-organ injuries and significant mortality in severe and critical patients, especially among those individuals with type 2 diabetes (T2D) as a comorbidity. While attenuated mortality was observed with aggressive glucose control, it was unclear whether therapeutic regiments including insulin treatment was beneficial for patients with COVID-19 and

Read More


Antibodies capable of neutralising SARS-CoV-2 persist for at least 3 months in most Covid-19 patients, even those who had mild disease.

The SARS-CoV-2 virus is causing a global pandemic and cases continue to rise. Most infected individuals experience mildly symptomatic coronavirus disease 2019 (COVID-19), but it is unknown whether this can induce persistent immune memory that could contribute to immunity. In this paper, published on Cell, it’s performed a longitudinal assessment of individuals recovered from mild

Read More


Thromboembolism risk of COVID-19 is high and associated with a higher risk of mortality: A systematic review and meta-analysis published on EClinicalMedicine.

Early reports indicated that in COVID-19 may be associated with coagulation dysfunction. Studies have reported varying rates of thromboembolism. In this paper, the Authors searched PubMed, Cochrane and Embase for systematic reviews and meta-analyses evaluating thromboembolism rates in COVID-19 published until June 12, 2020. The search terms were “COVID-19”, “SARS-CoV-2” or “novel coronavirus” and “venous

Read More


Oxford coronavirus vaccine produces strong immune response in older adults as published in The Lancet

The ChAdOx1 nCov-2019 coronavirus vaccine, developed by teams at the University of Oxford, has been shown to trigger a robust immune response in healthy adults aged 56-69 and those over 70 years of age. The data, published in The Lancet, suggest that one of the groups most vulnerable to serious illness, and death from COVID-19, could build

Read More


The Most Logical Approach to Improve CAR T Cell Therapy: a preview on Cell Systems

Combinational antigen recognition is the most logical way to improve the safety of cancer therapy. CAR T cells therapy, combined with synthetic biology, protein engineering, and bioinformatics, can perform advanced computations to enhance tumor targeting specificity. Immunotherapy, including biologic and cellular approaches, is a critical area of focus for cancer therapeutics. Of the methodologies used

Read More


Baricitinib treatment linked to reduced mortality in COVID-19 patients

The rheumatoid arthritis drug baricitinib can block viral entry and reduce mortality in patients with moderate to severe COVID-19, according to translational research by an international team coordinated by researchers from Karolinska Institutet in Sweden. The findings, published in the journal Science Advances, support the continuation of ongoing randomized clinical trials. “We are pleased to

Read More


Macrophage expression and prognostic significance of the long pentraxin PTX3 in COVID-19

As of 20 November 2020, the number of COVID-19 cases was reported to be more than 57 million, leading to more than 1.361,000 deaths worldwide . Elevated levels of CRP, cytokine and chemokines, together with low lymphocyte and eosinophil counts, characterize patients with severe disease. However, a reliable biomarker of poor outcome in COVID-19 is

Read More


In the lab, St. Jude scientists redefine cytokine storm and identify possible COVID-19 treatment

Immunologists have determined the process driving life-threatening inflammation, lung damage and organ failure in patients with COVID-19, sepsis and other inflammatory disorders suggesting possible treatment using existing drugs. The COVID-19 pandemic continues to cause significant illness and death while treatment options remain limited.St. Jude Children’s Research Hospital scientists have discovered a potential strategy to prevent life-threatening

Read More


Pfizer and BioNTech conclude Phase 3 study of Covid-19 Vaccine candidate, meeting all primary efficacy endpoints

Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of

Read More


Data released by the American Academy of Pediatrics and the Children’s Hospital Association find that more than 1 million kids have now been diagnosed with Covid-19.

State-level reports are the best publicly available data on child COVID-19 cases in the United States. The American Academy of Pediatrics and the Children’s Hospital Association are collaborating to collect and share all publicly available data from states on child COVID-19 cases (definition of “child” case is based on varying age ranges reported across states;

Read More


For an Oxford University research, videogaming is positively correlated with well-being. RESTORE consortium videogame “Fragments of Life” helps to enter into CAR-T Cells breakthrough therapy in Acute Lymphoblastic Leukemia.

Conventional wisdom has it that too many cooks spoil the broth. But such judiciousness is not usually considered the basis for scientific pronouncements or international rulings on the need to limit the number of people in kitchens. But, when it comes to video games, conventional wisdom, not science, forms the basis for our thinking and

Read More


CAR-T cell therapy as a “game changer” therapy in paediatric acute lymphoblastic leukaemia: past, present and future. A review of the British Society for Haematology.

Over the last decade, chimeric antigen receptor (CAR)-T cell therapy has emerged as a promising treatment modality for relapsed/refractory B-cell malignancies in both children and adults. As an adoptive immune therapy, CAR-T cells have the potential to overcome disease that is resistant to chemoand radiotherapy as well as represent a viable option for those who

Read More


Dissecting the immune characteristics of severe COVID-19 responses: Increased IL-10-producing regulatory T cells are characteristic of severe cases of COVID-19

Key points: Researchers have analysed immune cell types and numbers from the blood of healthy volunteers, COVID-19 patients experiencing mild-to-moderate effects and patients classified as severe to understand whether particular characteristics of their immune system response can identify treatment targets or indicate disease severity. After comparing the T cell immune response, the researchers noted the

Read More


Expression of SARS-CoV-2 Entry Factors in the Pancreas of Normal Organ Donors and Individuals with COVID-19. SARS-CoV-2 infection of pancreatic endocrine cells, via ACE2, is an unlikely central pathogenic feature.

Diabetes is associated with increased mortality from Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). Given literature suggesting a potential association between SARS-CoV-2 infection and diabetes induction, it was examined pancreatic expression of angiotensin-converting enzyme-2 (ACE2), the key entry factor for SARS-CoV-2 infection. Specifically, in this paper published on Cell Metabolism, were analyzed five public scRNA-seq pancreas

Read More


A clade of SARS-CoV-2 viruses associated with lower viral loads in patient upper airways: an investigation on the phylogenetic characteristics of SARS-CoV-2 infections in Chicago.

The rapid spread of SARS-CoV-2, the causative agent of Coronavirus disease 2019 (COVID-19), has been accompanied by the emergence of distinct viral clades, though their clinical significance remains unclear. In this paper it’s investigated the phylogenetic characteristics of SARS-CoV-2 infections in Chicago, Illinois, and assessed their relationship to clinical parameters. Whole-genome sequencing of SARS-CoV-2 isolates

Read More


A Series of Disappointing Results of Immune-Based Therapies for COVID-19

It’s been a tough couple of weeks for immune-based therapies for COVID-19. We know that immune modulation in this disease, especially in its most severe manifestations, can improve outcomes. Favorable results from the RECOVERY study of dexamethasone have made it the standard of care for most hospitalized patients who require oxygen. And we also know that our own immune

Read More


Treatments for People with Early COVID-19 Infection is an Urgent Research Focus, according to a JAMA Viewpoint article by NIAID Director Anthony S. Fauci, M.D., and colleagues.

Effective, Early Interventions would Benefit Individual Patients and Healthcare System COVID-19 treatments for people with early infection are needed urgently, according to a JAMA Viewpoint article by NIAID Director Anthony S. Fauci, M.D., and colleagues. Treating people early in the course of infection with SARS-CoV-2, the virus that causes COVID-19, would speed their recovery, reduce

Read More


Real-time Conformational Dynamics of SARS-CoV-2 Spikes on Virus Particles with four distinct FRET efficiency states, enhanced by proteolysis. Convalescent plasma antibodies exert a double action.

SARS-CoV-2 spike (S) mediates viral entry into cells and is critical for vaccine development against COVID-19. Structural studies have revealed distinct conformations of S, but real-time information that connects these structures, is lacking. In this paper it’s applied single-molecule Fluorescence (Förster) Resonance Energy Transfer (smFRET) imaging to observe conformational dynamics of S on virus particles.

Read More


Inhaled nebulised Interferon beta-1a may help Covid-19 patients, in a randomised, double-blind, placebo-controlled, phase two trial.

An inhaled form of interferon — a drug commonly used to treat multiple sclerosis by injection — may help protect hospitalized Covid-19 patients from getting worse, according to a British drugmaker. Results were first released in July, but were published Thursday as a peer-reviewed study in The Lancet Respiratory Medicine. The body naturally releases interferon when

Read More


Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19. A Randomized Clinical Trial

An obsessive compulsive disorder (OCD) drug may help improve the conditions of coronavirus patients, a new study suggests. Fluvoxamine, sold under the brand name Luvox, is a medication that scientists believe has anti-inflammatory properties, which can help control the immune system’s overreaction to the virus.  No patient who was given the drug suffered from shortness of breath

Read More


Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US FDA

To understand the usual approval process followed by the FDA, researchers of the Yale University School of Medicine have systematically evaluated all novel vaccines approved by the FDA over the last decade, characterizing the premarket development and regulatory review times, the clinical evidenceon which approval was based, and the size and follow-up duration of the

Read More


FDA issues EUA for Bamlanivimab Monoclonal Antibody for Treatment of mild-to-moderate COVID-19

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about

Read More


Baricitinib treatment resolves lower airway macrophage inflammation and neutrophil recruitment in SARS-CoV-2-infected rhesus macaques. Running NIH clinical trial in association with remdesivir.

SARS-CoV-2 induced hypercytokinemia and inflammation are critically associated with COVID19 disease severity. Baricitinib, a clinically approved JAK1/2 inhibitor, is currently being investigated in COVID-19 clinical trials. In this paper published on Cell, are investigated the immunologic and virologic efficacy of baricitinib in a rhesus macaque model of SARS-CoV-2 infection. Viral shedding measured from nasal and

Read More


Hydroxychloroquine does not benefit adults hospitalized with COVID-19

A National Institutes of Health clinical trial evaluating the safety and effectiveness of hydroxychloroquine for the treatment of adults with coronavirus disease 2019 (COVID-19) has formally concluded that the drug provides no clinical benefit to hospitalized patients. Though found not to cause harm, early findings in June when the trial was stopped indicated that the

Read More


Final report of the NIAID Adaptive COVID-19 Treatment Trial (ACTT-1) confirms remdesivir benefits for COVID-19

Remdesivir is an antiviral medication that targets a range of viruses. It was originally developed over a decade ago to treat hepatitis C and a cold-like virus called respiratory syncytial virus (RSV). Remdesivir wasn’t an effective treatment for either disease. But it showed promise against other viruses. Researchers tested remdesivir in clinical trials during the

Read More


Gene therapy technique to regenerate the optic nerve offers hope for future glaucoma treatment

Scientists at University of Cambridge have used gene therapy to regenerate damaged nerve fibres in the eye, in a discovery that could aid the development of new treatments for glaucoma, one of the leading causes of blindness worldwide. Axons – nerve fibres – in the adult central nervous system (CNS) do not normally regenerate after

Read More


COVID-19 lung damage caused by persistence of ‘abnormal cells’

Investigations of deceased COVID-19 patients have shed light on possible lung damage caused by the virus. The study, published today in The Lancet’s eBioMedicine, by King’s in collaboration with University of Trieste and the International Centre for Genetic Engineering and Biology in Italy, shows the unique characteristics to the SARS-CoV-2 virus and may explain why

Read More


New Cause of COVID-19 Blood Clots Identified. Half of the patients with severe COVID-19 exhibits a combination of high levels of antiphospholipids antibodies and NET’s: dipyridamole potential therapy.

A new study reveals the virus triggers production of antibodies circulating through the blood, causing clots in people hospitalized with the disease. Blood clots continue to wreak havoc for patients with severe COVID-19 infection, and a new study explains what may spark them in up to half of patients. The culprit: an autoimmune antibody that’s

Read More


Coagulopathy as a Prodrome of Cytokine Storm in COVID-19-Infected Patients

Integrated analysis revealed a positive correlation of coagulopathy withcytokine storm in COVID-19-infected patients; the D-dimer rises early, which indicates that coagulopathy acts as a prodrome of cytokine storm. Coagulopathy can be used to monitor early cytokine storm in COVID-19-infected patients. Coagulopathy appeared around a few days in advance of a cytokine storm. It was also

Read More


New Landmark Study at UM School of Medicine Finds Aspirin Use Reduces Risk of Death in Hospitalized COVID-19 Patients

Hospitalized Patients Who Were Taking Daily Aspirin Had Lower Risk of ICU Admission, Ventilation, and Dying from the Virus Hospitalized COVID-19 patients who were taking a daily low-dose aspirin to protect against cardiovascular disease had a significantly lower risk of complications and death compared to those who were not taking aspirin, according to a new

Read More


NIH researchers discover that β-Coronaviruses use lysosomes for egress instead of the biosynthetic secretory pathway

Targeting cells’ ‘trash compactor’ could lead to new antiviral strategy to fight COVID-19. Researchers at the National Institutes of Health have discovered a biological pathway that the novel coronavirus appears to use to hijack and exit cells as it spreads through the body. A better understanding of this important pathway may provide vital insight in

Read More


What to make of “re-positive” SARS-CoV-2 molecular test results

In a Commentary on EBioMedicine researchers of Icahn School of Medicine at Mount Sinai, New York try to solve the enigma between dead viral particles testing or real clinical reinfection. Nine months after the first reports describing a novel corona virus (Severe Acute Respiratory Syndrome coronavirus 2, SARS-CoV-2) causing severe disease in humans (coronavirus Disease

Read More


New York University researchers using leukemia-on-a-chip dissect the chemoresistance mechanisms in B cell acute lymphoblastic leukemia bone marrow niche. A new opportunity for CAR-T cells therapy improving.

B cell acute lymphoblastic leukemia (B-ALL) blasts hijack the bone marrow (BM) microenvironment to form chemoprotective leukemic BM “niches,” facilitating chemoresistance and, ultimately, disease relapse. However, the ability to dissect these evolving, heterogeneous interactions among distinct B-ALL subtypes and their varying BM niches is limited with current in vivo methods. In this paper , New

Read More


Aprotinin Inhibits SARS-CoV-2 Replication and is identified as a potential drug candidate for Covid-19 treatment. Can human plasma have the same effect?

Researchers from the University of Kent, the Goethe-University in Frankfurt am Main (Germany), and the Hannover Medical School (Germany) have identified a drug with the potential to provide a treatment for COVID-19. The international team led by Professor Martin Michaelis, Dr. Mark Wass (both School of Biosciences, University of Kent), and Professor Jindrich Cinatl (Institute

Read More


A new report of London Imperial College shows COVID-19 fatality ratio estimated from seroprevalence is about 1%

The COVID infection fatality ratio is around 1% in high-income countries, but substantially lower in low-income countries with younger populations. These are the findings of a new report from the Imperial College London COVID-19 Response Team. The report reveals that: In high income countries, the estimated overall infection fatality ratio (IFR) is 1.15% (95% prediction interval

Read More


A direct drive parallel plane piezoelectric needle positioning robot for MRI guided intraspinal injection

Lower back pain caused by degenerative disc disorder affects approximately 40% of the population over 40 and though many of us may never experience adverse effects from the disorder, it is the cause of chronic back pain for numerous Americans. Recent imaging diagnostics and cellular based direct-injection therapeutics for degenerative disc and spinal cord injuries

Read More


Early results from DETECT study suggest fitness trackers and smartwatches can predict COVID-19 infection

Sensor data from wearable devices can complement virus testing and conventional screening to signal new infections. Examining data from the first six weeks of their landmark DETECT study, a team of scientists from the Scripps Research Translational Institute sees encouraging signs that wearable fitness devices can improve public health efforts to control COVID-19. The DETECT study, launched

Read More


COVID-19 Immune Response Study of the ISB-Swedish COVID-19 Immune Response Study Could Lead to More Effective Treatments

The ISB-Swedish COVID-19 Immune Response Study has revealed new findings that suggest that treatments aimed at arresting the infection at the stage of moderate severity may be most effective. The symptoms of COVID-19 vary widely, from very mild to severe conditions requiring ICU care. Researchers comprehensively studied a large number of patients during the week

Read More


New inflammatory disorder called vacuoles, E1 enzyme, X-linked, autoinflammatory and somatic syndrome (VEXAS) discovered by NIH researchers

Researchers from the National Institutes of Health (NIH) have discovered a new inflammatory disorder called vacuoles, E1 enzyme, X-linked, autoinflammatory and somatic syndrome (VEXAS), which is caused by mutations in the UBA1 gene. VEXAS causes symptoms that included blood clots in veins, recurrent fevers, pulmonary abnormalities and vacuoles (unusual cavity-like structures) in myeloid cells. The scientists reported

Read More


Use of mesenchymal stem cells in COVID-19 mediated acute respiratory failure: a review published on npj regenerative medicine.

In patients with critical manifestations of COVID-19, life-threatening complications such as ARDS and multiple organ dysfunction are mediated by extensive inflammation, neutrophils recruitment, cytokine storm syndrome and dysregulated immune innate responses. MSCs because of their immunomodulatory, regenerative, and antimicrobial properties could render several therapeutic effects in the setting of COVID-19. While data from countless clinical

Read More


FDA Clearance of IND Application for First-in-Class Allogeneic CAR Gamma-Delta T Cell Therapy in non-Hodgkin’s Lymphoma.

Phase 1 Clinical Study will Evaluate ADI-001 Safety and Efficacy in Patients with B-cell non-Hodgkin’s lymphoma Adicet Bio, Inc., a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-001,

Read More


COVID-19 and Lombardy: TESTing the impact of the first wave of the pandemic. Seroprevalence in the Bergamo area is 38.5%.

The emergence of a novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) caused a major disease outbreak that posed a threat to public health worldwide. Among the western countries, Italy was the first to experience a vast Coronavirus Disease 2019 (COVID-19) outbreak and the province of Bergamo experienced the deadliest COVID-19 outbreak in theworld. Due

Read More


Researchers of NEI use gene therapy and a novel light-sensing protein to restore vision in mice

NIH-funded therapy will now be tested in humans A newly developed light-sensing protein called the MCO1 opsin restores vision in blind mice when attached to retina bipolar cells using gene therapy. The National Eye Institute, part of the National Institutes of Health, provided a Small Business Innovation Research grant to Nanoscope, LLC for development of

Read More


Masks could cut COVID-19 deaths in the US by 130,000: IHME COVID-19 Forecasting Team study shows

Even if state-level governments in the United States reimpose limited social distancing measures to halt the spread of COVID-19, the death toll could more than double by the end of February 2021 to 511,000, according to projections released Friday. Near-universal mask wearing over the coming months could reduce that grim tally by nearly 130,000, researchers

Read More


Neutrophils express non-canonical functions, including vascular repair and hematopoietic homeostasis.

Scientists at the Centro Nacional de Investigaciones Cardiovasculares (CNIC) have discovered that neutrophils, the most abundant cells of the innate immune system, have many more functions in the body than previously thought. This finding suggests possible new treatments for many diseases, including cancer. In a study published in the journal Cell, the research team demonstrates that

Read More


Neuropilin-1 facilitates SARS-CoV-2 cell entry and infectivity

Researchers have identified a second receptor that might be important in SARS-CoV-2 infectivity, according to a new report published in Science on October 20. This cofactor helps facilitate virus-host cell interactions in cells with low levels of angiotensin-converting enzyme 2 (ACE2), the primary receptor on host cells, and might explain the increased pathogenicity of SARS-CoV-2. Why is

Read More


In an open label phase II multicentre randomised controlled trial (PLACID Trial) convalescent plasma isn’t associated with a reduction in disease progression or all cause mortality in moderate Covid-19.

Convalescent plasma may not prevent progression to severe disease or reduce mortality risk in hospitalized patients with moderate COVID-19, based on a phase 2 trial involving more than 400 patients in India. The PLACID trial offers real-world data with “high generalizability,” according to lead author Anup Agarwal, MD, of the Indian Council of Medical Research,

Read More


SARS-CoV-2 infects the brain choroid plexus and disrupts the blood-CSF-barrier in human brain organoids.

Coronavirus disease-19 (COVID-19), caused by the SARS-CoV-2 virus, leads to respiratory symptoms that can be fatal. However, neurological symptoms have also been observed in some patients. The cause of these complications is currently unknown. In this paper, were use human pluripotent stem cell-derived brain organoids to examine SARS-CoV-2 neurotropism. Was found expression of viral receptor

Read More


NIH launched the ACTIV-5/BET study, a randomized, double-blind, placebo-controlled trial testing risankizumab or lenzilumab +remdesivir in Covid-19 treatment.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and merit advancement into larger clinical trials. The ACTIV-5 Big Effect Trial, which will enroll adult volunteers hospitalized

Read More


Therapeutic Management of Patients with COVID-19. Updated Treatment Guidelines released by NIH.

A number of investigational agents and drugs that are approved for other indications are currently being studied in clinical trials for the treatment of COVID-19 and associated complications. Data from randomized controlled trials, prospective and retrospective observational cohorts, and case series studies are rapidly emerging. The COVID-19 Treatment Guidelines Panel (the Panel) continues to review

Read More


For NIH updated treatment guidelines, insufficient data from well-controlled, adequately powered, randomized clinical trials to evaluate the efficacy and safety of convalescent plasma for the treatment of COVID-19.

Last Updated: October 9, 2020 Plasma from donors who have recovered from COVID-19 may contain antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that may help suppress the virus and modify the inflammatory response.1 Recommendation There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the

Read More


Antiviral monotherapy for hospitalised patients with COVID-19 is not enough. Lopinavir-Ritonavir no benefit in patients admitted.

No reductions seen in 28-day mortality or duration of hospital stay in COVID-19 with lopinavir-ritonavir. Lopinavir-ritonavir is not associated with reductions in 28-day mortality or duration of hospital stay among patients admitted to the hospital with COVID-19, according to a study published online Oct. 5 in The Lancet. Peter W. Horby, M.D., Ph.D., and colleagues on

Read More


COVID-19 and Excess All-Cause Mortality in the US and 18 Comparison Countries. Research letter on JAMA.

Was compared the US to Organisation for Economic Co-operation and Development countries with populations exceeding 5million and greater than $25 000 per capita gross domestic product. For each country, was calculated the COVID-19 per capita mortality rate and grouped countries by mortality: (1) low (COVID-19 deaths, <5/100 000), (2) moderate (5-25/ 100 000), and (3)

Read More


Clinical Development of Gene Therapies: The First Three Decades and Counting.

In the past three decades the field of gene therapy has made remarkable progress surging from mere laboratory experiments to FDA-approved products which bring significant reduction in disease burden to patients who previously had no therapeutic options for their serious conditions. In this paper it’s reviewed the evolution of the gene therapy clinical research landscape

Read More


Thromboprophylaxis with enoxaparin is associated with a lower death rate in patients hospitalized with SARS-CoV-2 infection. A cohort study published on EClinicalMedicine

Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection is associated with hypercoagulability caused by direct invasion of endothelial cells and\or proinflammatory cytokine release. Thromboprophylaxis with enoxaparin is recommended by current guidelines, but evidence is still weak. The aim of this study was to assess the impact of thromboprophylaxis with enoxaparin on hospital mortality in patients

Read More


RESTORE community has released new position paper on advanced therapies.

The RESTORE position paper represents the cumulative efforts of the RESTORE community, and the steering committee since the start of the RESTORE initiative in 2019. It outlines, in depth, the RESTORE view on why Europe should invest in Advanced Therapies, the roadblocks in Advanced Therapy development and implementation into patient care, and makes recommendations about

Read More


The role for the metagenome and the influence of microbiota on immune processes in the pathogenesis of COVID-19 infection.

A new paper published on EBioMedicine analyzes metagenome contribution to Covid-19 response variability. A key question concerning COVID-19 is why most infected persons do not develop severe disease, while others become critically ill. This dichotomy is related to age, gender, immunosuppression and comorbidities, but many persons who are young succumb to the virus. A significant

Read More


Neutrophil proteolytic enzymes storm triggers vascular disease and thrombosis in SARS-CoV-2 infected Rhesus Macaques

The COVID-19 pandemic has led to extensive morbidity and mortality throughout the world. Clinical features that drive SARS-CoV-2 pathogenesis in humans include inflammation and thrombosis, but the mechanistic details underlying these processes remain to be determined. In this study, was demonstrated endothelial disruption and vascular thrombosis in histopathologic sections of lungs from both humans and

Read More


SARS-CoV-2 disrupts splicing, translation, and protein trafficking to suppress host interferons

SARS-CoV-2 is a recently identified coronavirus that causes the respiratory disease known as COVID-19. Despite the urgent need, it’s not fully understood the molecular basis of SARS-CoV-2 pathogenesis. In this paper, are comprehensively defined the interactions between SARS-CoV-2 proteins and human RNAs. NSP16 binds to the mRNA recognition domains of the U1 and U2 splicing

Read More


A large-scale Multi-omic Analysis shows neutrophil degranulation, vessel damage, platelet activation and degranulation, blood coagulation and complement activation are responsible for COVID-19 Severity

RNA-Seq and high-resolution mass spectrometry on 128 blood samples from COVID-19 positive and negative patients with diverse disease severities and outcomes were performed and published on Cell Systems Quantified transcripts, proteins, metabolites, and lipids were associated with clinical outcomes in a curated relational database, uniquely enabling systems analysis and cross-ome correlations to molecules and patient

Read More


Sarilumab use in severe SARS-CoV-2 pneumonia. IL-6 blockade inhibits neutrophil recruitment and innate immune response harm.

Interleukin-6 signal blockade showed preliminary beneficial effects in treating inflammatory response against SARS-CoV-2 leading to severe respiratory distress. In this paper, published on EClinicalMedicine are described the outcomes of off-label intravenous use of Sarilumab in severe SARS-CoV-2-related pneumonia. 53 patients with SARS-CoV-2 severe pneumonia received intravenous Sarilumab; pulmonary function improvement or Intensive Care Unit (ICU)

Read More


Imbalance of regulatory and cytotoxic SARS-CoV-2-reactive CD4+ T cells in COVID-19

The contribution of CD4 + T cells to protective or pathogenic immune responses to SARS-CoV-2 infection remains unknown. In this paper it’s presented single-cell transcriptomic analysis of >100,000 viral antigen-reactive CD4 + T cells from 40 COVID-19 patients. In hospitalized patients compared to non-hospitalized patients, were found increased proportions of cytotoxic follicular helper (T FH

Read More


COVID-19 and Heart Failure With Preserved Ejection Fraction

The more common manifestation in the COVID-19 era may be HFpEF related primarily to the unmasking of subclinical HFpEF and secondarily to the development of new HFpEF following infection with SARS-CoV-2. Patients with preexisting cardiovascular disease (CVD) who develop coronavirus disease 2019 (COVID-19) have worse outcomes than patients without CVD.Infection with severe acute respiratory syndrome

Read More


Fewer than 10% of the US adult population formed antibodies against SARS-CoV-2, and fewer than 10% of those with antibodies were diagnosed.

Fewer than 10 percent of the U.S. adult population formed antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the first wave of the pandemic, according to a study published online Sept. 25 in The Lancet. Shuchi Anand, M.D., from the Stanford University School of Medicine in Palo Alto, California, and colleagues conducted a cross-sectional

Read More


New randomized clinical trial suggests Hydroxychloroquine failure even as a COVID19 preventative in healthcare workers

In this randomized clinical trial, although limited by early termination, there was no clinical benefit of hydroxychloroquine administered daily for 8 weeks as pre-exposure prophylaxis in hospital-based HCWs exposed to patients with COVID-19. Despite promising early reports and strong in vitro performance, Hydroxychloroquine (HCQ) has become the major therapeutic disappointment of the COVID pandemic. Research

Read More


This week’s Offline column by The Lancet Editor-in-Chief defines Covid-19 Syndemic not Pandemic.

Two categories of disease are interacting within specific populations—infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and an array of non-communicable diseases (NCDs). These conditions are clustering within social groups according to patterns of inequality deeply embedded in our societies. The aggregation of these diseases on a background of social and economic disparity exacerbates

Read More


A multicenter cardiovascular pathology study shows various features of COVID-19-associated myocardial injury

Early in the pandemic, other clinicians noted that even some patients who didn’t have preexisting heart conditions experienced cardiovascular damage while fighting COVID-19 infections, pointing to a possible causative link. Researchers had found, for example, that 8–12 percent of hospitalized COVID-19 patients had elevated levels of muscle contraction–regulating proteins called troponins—a sign of heart damage—and that these

Read More


Convalescent Plasma for the Treatment of COVID-19: Perspectives of the National Institutes of Health COVID-19 Treatment Guidelines Panel

Currently, no Food and Drug Administration (FDA)-approved therapeutics exist for coronavirus disease 2019 (COVID-19). In this context, the pandemic has put considerable pressure on health care providers to prescribe treatments despite limited information about their safety and efficacy. This pressure has exacerbated the tension between the importance of practicing evidence-based medicine and the urgency of

Read More


Scientists discover 13,5% cases of severe Covid-19 present genetic and immunologic underpinnings inducing type I Interferon lacking

New findings by scientists at the National Institutes of Health and their collaborators help explain why some people with COVID-19 develop severe disease. The findings also may provide the first molecular explanation for why more men than women die from COVID-19. The researchers found that more than 10% of people who develop severe COVID-19 have

Read More


Susceptibility to SARS-CoV-2 Infection Among Children and Adolescents Compared With Adults: A Systematic Review and Meta-analysis

Children were less likely than adults to acquire a COVID-19 infection from an index case, a meta-analysis found. Across 32 contact tracing or population testing studies comparing SARS-CoV-2 prevalence in children and adults, children younger than 14 were less likely to be infected from an index case overall (odds ratio 0.56, 95% CI 0.37-0.85), and

Read More


Gastrointestinal Complications in Critically Ill Patients With and Without COVID-19

COVID-19 appears to have significant extrapulmonary complications affecting multiple organ systems. Critically ill patients with COVID-19 oftendevelop gastrointestinal complications during their hospital stay, including bowel ischemia, transaminitis, gastrointestinal bleeding, pancreatitis, Ogilvie syndrome, and severe ileus. Whether the high incidence of gastrointestinal complications is a manifestation of critical illness in general or is specific to COVID-19

Read More


Toward an Optimized Process for Clinical Manufacturing of CAR-Treg Cell Therapy

Chimeric antigen receptor (CAR) technology and its application to regulatory T cells (Tregs) has garnered interest among researchers in the field of cell and gene therapy. Merging the benefits of CAR technology with Tregs offers a novel and promising therapeutic option for durable reshaping of undesired immune responses following solid organ or hematopoietic stem cell

Read More


People with asymptomatic SARS-CoV-2 infection have an upper respiratory viral load as those with mild symptoms

They are relatively common so may act as important driver of viral spread, warn researchers People with ‘silent’ COVID-19 infection have as much coronavirus in their noses and throats as those with symptoms, reveals research published online in the journal Thorax. Given how many of these people there are—a fifth of those infected, the study findings show–they may

Read More


Modulating endothelial adhesion and migration impacts stem cell therapies efficacy

Despite the first clinical studies reporting on a correlation betweenthe migration potential of transplanted stem cells and their therapeutic efficacy, it is unclear if effective stem cell therapies requirereliable and sufficient delivery of the cells to the desired anatomiclocations, as well as survival of the cellular graft. Moreover, the many complex processes involved in stem

Read More


FDA Approves Study to Investigate the Use of Cell Therapy to Treat COVID-19 Related Multisystem Inflammatory Syndrome in Children (MIS-C)

First-of-its kind study to be supported by the Cura Foundation, The Marcus Foundation, Sanford Health and Alliance for Cell Therapy Now The Cura Foundation in collaboration with The Marcus Foundation, Sanford Health and Alliance for Cell Therapy Now, is supporting a clinical trial of human cord tissue mesenchymal stromal cells (hCT-MSC) to treat children with

Read More


Frequency of Children vs Adults Carrying Severe Acute Respiratory Syndrome Coronavirus 2 Asymptomatically

The frequency of children carrying asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been suggested to be higher than among adults. It is also suggested that asymptomatic children enhance viral spread. A research letter by published in the journal JAMA Pediatrics in September 2020 explores the truth of this common belief. Earlier Research Earlier studies

Read More


Efficacy of convalescent plasma against COVID19 requires early therapy with high titer plasma. RCTs need to be designed on this basis.

In a paper published on EClinicalMedicine, has been assessed outcome of patients with moderate and severe COVID-19 following treatment with convalescent plasma (CP) and the association with IgG levels in transfused CP. A prospective cohort study. Primary outcome was improvement at day 14 defined as alive, not on mechanical ventilation, and moderate, mild, or recovered

Read More


Assessment of the immune response in kids with MIS-C, identifying candidate autoantibodies resembling antibody response to convalescent Covid.

Initially, children were thought to be spared from disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, a month into the epidemic, a novel multisystem inflammatory syndrome in children (MIS-C) emerged. In thi paper on Cell, are reported the immune profiles of nine MIS-C cases. All MIS-C patients had evidence of prior SARS-CoV-2

Read More


Racial/Ethnic Variation in Nasal Gene Expression of Transmembrane Serine Protease 2 (TMPRSS2)

In a study published in JAMA today, Mount Sinai researchers report findings that shed some light on the disproportionate impact of COVID-19 on Blacks, who have experienced rates of infection and death that are much greater, in some areas twice and three times more, than their proportion of the population. Our study suggests one factor that may

Read More


COVID-19 and the Path to Immunity

The emergence of adaptive immunity in response to the new Betacoronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), occurs within the first 7 to 10 days of infection. Understanding the key features and the B-cell evolution – and T-cell-mediated adaptive immunity to SARS-CoV-2 is essential to predict the outcomes of coronavirus disease 2019 (COVID-19) and

Read More


Human Mesenchymal Stromal Cells are resistant to SARS-CoV-2 Infection

Mesenchymal stem/stromal cells are not infected by SARS-CoV-2 and retain their immunomodulatory potential as published by Institute for Transfusion Medicine and Immunohaematology, German Red Cross Blood Donor Service in Frankfurt am Main on Stem Cells Report. Previous studies reported safety and applicability of Mesenchymal Stem/Stromal Cells (MSC) to ameliorate pulmonary inflammation in ARDS. Thus, multiple

Read More


Rare hyperinflammatory syndrome in children with COVID-19 described

Researchers at Karolinska Institutet and Science for Life Laboratory in Sweden and Tor Vergata University of Rome in Italy have mapped the immune response in children affected by a rare but life-threatening inflammatory syndrome associated with COVID-19. The study, which is published in the scientific journal Cell, reveals that the inflammatory response differs from that

Read More


Post-COVID syndrome severely damages children’s hearts — systematic review

Multisystem inflammatory syndrome in children (MIS-C), believed to be linked to COVID-19, damages the heart to such an extent that some children will need lifelong monitoring and interventions, said the senior author of a medical literature review. Case studies also show MIS-C can strike seemingly healthy children without warning three or four weeks after asymptomatic

Read More


Obesity, diabetes and hypertension greatest risk factors for young adults with COVID-19

Young adults with underlying conditions such as morbid obesity, diabetes and hypertension are at the highest risk of being placed on a ventilator or dying from COVID-19, according to a study of 3,000 hospitalized patients aged 18 to 34. The analysis, published Wednesday in the journal JAMA Internal Medicine, focused on patients hospitalized between April and

Read More


Facial Masking for Covid-19 could expose wearers to just enough of the virus that it helps trigger immunity.

SARS-CoV-2, the virus that causes COVID-19, is entirely new to infectious disease researchers and other public health scientists. To combat it, scientists have sifted through centuries of literature about how the world coped with past pandemics. A new opinion paper assesses one way in which we might be able to learn from our encounters with

Read More


Convalescent plasma fails to improve outcome of COVID-19 in PLACID trial. Limits of the study.

The COVID-19 pandemic is still raging in India, with over 4.5 million cases, 75.000 deaths and more than 90,000 new cases a day. At present there are few effective therapeutic options, which means that healthcare providers are faced with ongoing challenges in managing the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A new study based

Read More


SARS-CoV-2 ORF3b is a potent interferon antagonist and its activity is increased by a naturally occurring elongation variant

One of the features distinguishing SARS-CoV-2 from its more pathogenic counterpart SARS-CoV is the presence of premature stop codons in its ORF3b gene. In this paper it’s shown that SARS-CoV-2 ORF3b is a potent interferon antagonist, suppressing the induction of type I interferon more efficiently than its SARS-CoV ortholog. Phylogenetic analyses and functional assays reveal

Read More


Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19. Results of a WHO Meta-analysis

Treating critically ill COVID-19 patients with corticosteroid drugs reduces the risk of death by 20 percent, an analysis of seven international trials found on Wednesday, prompting the World Health Organization to update its advice on treatment. The analysis — which pooled data from separate trials of low dose hydrocortisone, dexamethasone and methylprednisolone — found that steroids improve survival

Read More


Patients with COVID-19 having a reduction in respiratory system compliance together with increased D-dimer concentrations have high mortality rates.

The study has been done in seven Italian Hospitals and published on The Lancet Respiratory Medicine The study confirms the role of microthrombosis in severe Covid-19, but do not explain which is the pathophysiology of the proteolytic cascades activation. For Dr. Fornasari, REGENHEALTHSOLUTIONS Director, “This study very important study shows that unhinibited proteolytic cascades activation

Read More


Children with no COVID-19 symptoms may shed virus for weeks: a new study confirms.

New research suggests that children can shed SARS-CoV-2, the virus that causes COVID-19, even if they never develop symptoms or for long after symptoms have cleared.  But many questions remain about the significance of the pediatric population as vectors for this sometimes deadly disease, according to an invited commentary by Children’s National Hospital doctors that accompanies this

Read More


UK-wide study shows children with gastrointestinal symptoms should be included in COVID-19 testing

Over 1,000 children from Northern Ireland, Scotland, England and Wales, known as ‘COVID Warriors’ have had their antibodies measured in the UK-wide trial called ‘Seroprevalence of SARS-Cov-2 infection in healthy children’. The findings have been published yesterday (Friday 28 August) as a pre-print on the server medRxiv. The study is led by Queen’s University Belfast, in

Read More


Mount Sinai Team Offers Additional Data on Efficacy of Blood Anticoagulation for COVID-19 and Insight on Best Potential Regimens

Study is the basis of a new international clinical trial Early in the COVID-19 pandemic, Mount Sinai researchers were among the first to show that anticoagulation therapy was associated with improved survival among hospitalized COVID-19 patients. But many questions remained—about the size of the potential benefit, and about what dosage of this therapy might be

Read More


A study confirms: with 95% masking, 57% of Covid-19 deaths could be prevented by fall.

A new Covid-19 prediction model makes another compelling case for wearing masks and cloth face coverings. If practically everyone in America wears masks while out in public, it could prevent tens of thousands of Covid-19 infections and deaths by the fall, according to researchers at the University of Washington’s Institute for Health Metrics and Evaluation (IHME). “It is hard

Read More


Mayo Clinic Driven Expanded Access Program for Convalescent Plasma discontinues enrollment as FDA authorizes its emergency use

The Food and Drug Administration (FDA) authorized emergency use of convalescent plasma and the national Expanded Access Program (EAP) for convalescent plasma led by Mayo Clinic announced its intention to discontinue enrollment. The five-month program served 2,780 hospital and acute care facilities, with nearly 14,000 physicians enrolling 101,000 patients and reports of 71,000 infused so far. Eligible patients who

Read More


Kidney involvement by SARS-CoV-2 increases the risk of mortality and acute kidney failure.

The research presented early in the course of Corona pandemic found that Covid-19 not as initially suspected a classic viral lung disease. Rather, the whole body is affected . A team from the University Hospital Hamburg-Eppendorf (UKE) has now proven that the new coronavirus  SARS-CoV-2 can also multiply in the kidneys .  The novel corona virus can also multiply outside of the lungs, for example in the kidneys. Researchers at the University Medical Center

Read More


Not only antibodies: the role of B cells and T cells in mediating immunity to COVID-19

Recent reports that antibodies to SARS-CoV-2 are not maintained in the serum following recovery from the virus have caused alarm. However, the absence of specific antibodies in the serum does not necessarily mean an absence of immune memory. University of Bergen researchers have just published a paper on Nature Reviews Immunology. Immunity after infection with

Read More


FDA Covid-19 Convalescent Plasma Emergency Use Authorisation: Truth beyond Fictions

Source FDA Yesterday 08/23/2020 FDA has issued guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. The guidance provides recommendations on the following: pathways for use of investigational COVID-19 convalescent plasma

Read More


Risk of stroke in hospitalized SARS-CoV-2 infected patients. Results of a multinational study

There is an increased attention to stroke following SARS-CoV-2. The goal of this study was to better depict the short-term risk of stroke and its associated factors among SARS-CoV-2 hospitalized patients. This multicentre, multinational observational study includes hospitalized SARS-CoV-2 patients from North and South America (United States, Canada, and Brazil), Europe (Greece, Italy, Finland, and

Read More


An uncontrolled and placebo group lacking study on 35.000 patients suggests convalescent plasma shows a 3% reduced mortality in Covid-19 patients.

Infusing hospitalized Covid-19 patients with blood plasma from people who recovered from the disease appeared to show a benefit in a nationwide study, but the study’s lack of a placebo group left several experts struggling to interpret the data. The study, which enrolled more than 35,000 patients, found that quickly administering so-called convalescent plasma had

Read More


Triad of molecules could predict severity of COVID-19

In a new study, published in Nature Medicine, researchers at the Francis Crick Institute, King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, have found a common immune signature in the blood of patients with COVID-19, which could be used to predict how severely ill a patient will become, thereby aiding patient management.  The team analysed blood samples

Read More


Effects of COVID-19 on the nervous system: a review published on Cell

Neurological complications have emerged as a significant cause of morbidity and mortality in the ongoing COVID-19 pandemic. Beside respiratory insufficiency, many hospitalized patients exhibit neurological manifestations, ranging from headache and loss of smell, to confusion and disabling strokes. COVID-19 is also anticipated to take a toll on the nervous system in the long term. In

Read More


Two existing drugs point to a potential new target against COVID-19

New lab-based studies show that two existing drugs, including one developed by a researcher at Harvard Medical School and Boston Children’s Hospital, inhibit SARS-CoV-2 — the virus that causes COVID-19 — from infecting human cells in a dish. Both drugs, vacuolin-1 and apilimod, originally developed years ago, target a large enzyme called PIKfyve kinase. Before

Read More


The six strains of SARS-CoV-2

The virus causing the COVID-19 pandemic, SARS-CoV-2, presents at least six strains. Despite its mutations, the virus shows little variability, and this is good news for the researchers working on a viable vaccine. These are the results of the most extensive study ever carried out on SARS-CoV-2 sequencing. Researchers at the University of Bologna drew

Read More


Quick and affordable saliva-based COVID-19 test developed by Yale scientists receives FDA Emergency Use Authorization

A saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public Health to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. Food and Drug Administration (FDA). The method, called SalivaDirect, is being further validated as a test for asymptomatic individuals through

Read More


Regenerative Medicine & Advanced Therapies Sector Thriving Despite COVID-19 following a new report by ARM

In the early days of COVID-19, the Alliance for Regenerative Medicine (ARM) was unsure how the pandemic and its accompanying economic downturn would affect the cell and gene therapy space. “It was a really specific time when the world and the markets were clearly reeling from the first appreciation for the seriousness of COVID-19,” Janet

Read More


Pharmacological activation of NRF2 could be a way to combat Acute respiratory distress syndrome caused by SARSCoV2.

Acute respiratory distress syndrome (ARDS) caused by SARS-CoV-2 is largely the result of a dysregulated host response, followed by damage to alveolar cells and lung fibrosis. Exacerbated proinflammatory cytokines release (cytokine storm) and loss of T lymphocytes (lymphopenia) characterize the most aggressive presentation. A multifaceted anti-inflammatory strategy, based on pharmacological activation of nuclear factor erythroid

Read More


Important paper published on Cell by Morens and Fauci on Emerging Pandemic Diseases: How We Got To COVID-19

Infectious diseases prevalent in humans and animals are caused by pathogens that once emerged from other animal hosts. In addition to these established infections, new infectious diseases periodically emerge. In extreme cases they may cause pandemics such as COVID-19; in other cases, dead end infections or smaller epidemics result. Established diseases may also re-emerge, for

Read More


Defined the role of neutrophil extracellular traps in COVID-19 vascular occlusion. Efficacy of desamethasone, heparin and convalescent plasma.

Two papers recently published on EBioMedicine confirm that the excessive NET formation drives immunopathology in severe COVID-19 associated disseminated pulmonary intravascular coagulopathy. Coronavirus induced disease 2019 (COVID-19) can be complicated by severe organ damage leading to dysfunction of the lungs and other organs. The processes that trigger organ damage in COVID-19 are incompletely understood. Samples

Read More


Robust T cell immunity in convalescent individuals with asymptomatic or mild COVID-19

Important study on T cells in SARSCoV2 published in Cell from Marcus Buggert et al. CIM Sweden Karolinska Institute. SARS-CoV-2-specific memory T cells will likely prove critical for long-term immune protection against COVID-19. In this paper are systematically mapped the functional and phenotypic landscape of SARS-CoV-2-specific T cell responses in unexposed individuals, exposed family members,

Read More


NIH will test synthetic monoclonal antibodies and other experimental therapeutics for mild and moderate COVID-19

Initial clinical trial to determine if monoclonal antibodies can shorten severity of COVID-19 in outpatients. Source NIH A Phase 2 clinical trial will evaluate the safety and efficacy of potential new therapeutics for COVID-19, including an investigational therapeutic based on synthetic monoclonal antibodies (mAbs) to treat the disease. Researchers sponsored by the National Institute of

Read More


Singapore scientists uncover SARS-CoV-2-specific T cell immunity in recovered COVID-19 & SARS patients, and in uninfected individuals

Singapore study shows that SARS-CoV-2-specific T cells are present in all recovered COVID-19 patients. These T cells were also found in all subjects who recovered from SARS 17 years ago, and in over 50% of both SARS-CoV-1 and SARS-CoV-2 uninfected individuals tested, suggesting that a level of pre-existing SARS-CoV-2 immunity is present in the general

Read More


Ineffectiveness of Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19

Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy ofthese therapies is limited. A multicenter, randomized, open-label, three-group, controlled trial was conducted involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters

Read More


High-dose glucocorticoids and IL-6 receptor inhibition reduce COVID-19-associated cytokine storm mortality

The Annals of the Rheumatic Diseases, the journal of the European League Against Rheumatism, EULAR, has published findings of an observational study on the treatment of patients with COVID-19-associated Cytokine storm syndrome (CSS). The study demonstrates that a treatment strategy combining intensive immunosuppression (using glucocorticoids and an IL-6 inhibitor) as well as close monitoring dramatically improves

Read More


International Society Thrombosis and Hemostasis Experts Explain New Blood Clotting Phenomenon in Hospitalized COVID-19 Patients

As the world continues to learn more about COVID-19, emerging data reveals that hospitalized patients with COVID-19 have an increased risk for blood clots. In a new Illustrated Review  published in Research and Practice in Thrombosis and Haemostasis (RPTH) , leading thrombosis experts Prof. Beverley Hunt, OBE, and Prof. Marcel Levi, explain a clotting phenomenon found in most hospitalized

Read More


Korean study shows teenagers may transmit COVID-19 as much as adults do

Since the early days of the coronavirus pandemic, scientists and health authorities have often observed that children do not appear to contract and transmit the virus to the same extent as adults. While the mechanisms behind this reduced vulnerability have remained somewhat mysterious and speculative, new evidence from South Korea shows that the age of children is also a vital factor to

Read More


Covid-19 and convalescent plasma treatment potential: the NIH position

Recommendation There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of COVID-19 convalescent plasma for the treatment of COVID-19. Rationale for Recommendation Thousands of patients in the United States have received COVID-19 convalescent plasma through clinical trials, expanded access treatment trials, and single-patient Emergency Investigational New

Read More


A synergistic role of convalescent plasma and mesenchymal stem cells in the treatment of severely ill COVID-19 patients: a clinical case report

Acute respiratory distress syndrome virus-2 (SARS-CoV-2) responsible for coronavirus disease 2019 (COVID-19) infection, which causes global public health emergencies, has sped widely for more than 5 months and has the risk of long-term transmission. No effective treatment has been discovered to date. In the cases reported, the patient continued to deteriorate even after administration of

Read More


Haematological characteristics and risk factors in the classification and prognosis evaluation of COVID-19: a retrospective cohort study

COVID-19 is an ongoing global pandemic. Changes in haematological characteristics in patients with COVID-19 are emerging as important features of the disease. The authors aimed to explore the haematological characteristics and related risk factors in patients with COVID-19. This retrospective cohort study included patients with COVID-19 admitted to three designated sites of Wuhan Union Hospital

Read More


Risk Factors Associated With Mortality Among Patients With COVID-19 in Intensive Care Units in Lombardy, Italy

This study, published on JAMA, evaluates the independent risk factors associated with mortality of patients with COVID-19 requiring treatment in ICUs in the Lombardy region of Italy. This retrospective, observational cohort study includes 3988 consecutive critically ill patients with laboratory-confirmed COVID-19 referred forICU admission to the coordinating center of the COVID-19 Lombardy ICU Network from

Read More


Prognostic factors associated with mortality risk and disease progression in 639 critically ill patients with COVID-19 in Europe: Initial report of the international RISC-19-ICU prospective observational cohort

Coronavirus disease 2019 (COVID-19) is associated with a high disease burden with 10% of confirmed cases progressing towards critical illness. Nevertheless, the disease course and predictors of mortality in critically ill patients are poorly understood. Following the critical developments in ICUs in regions experiencing early inception of the pandemic, the European-based, international RIsk Stratification in

Read More


Covid-19:RECOVERY trial publishes preprint on dexamethasone use in ventilated patients

University of Oxford’s RECOVERY trial published its much anticipated preprint paper on the drug’s effect on Covid-19. The paper states that the drug cuts deaths in ventilated patients by one third and deaths in other admitted patients receiving oxygen by only one fifth. The headline findings of the trial were reported by the investigators on 16

Read More


Mayo Clinic finds convalescent plasma safe for diverse patients with COVID-19

Mayo Clinic researchers and collaborators have found investigational convalescent plasma to be safe following transfusion in a diverse group of 20,000 patients. The findings — from the U.S. Food and Drug Administration’s Expanded Access Program for COVID-19 — are reported in Mayo Clinic Proceedings. The safety report assessed the seven days following transfusion for hospitalized patients between April

Read More


In JAMA Patient Page an information on Convalescent Plasma and Covid-19

Donated convalescent plasma may be beneficial to patients with severecoronavirus disease 2019 (COVID-19) to boost their ability to fight the virus. What Is Convalescent Plasma?Most people who recover from COVID-19 develop antibodies (proteins that the immune system produces in response to infection) to severe acute respiratory syndrome coronavirus 2 (SARSCoV-2). Antibodies are found in plasma,

Read More


MSC Therapy for Acute Respiratory Distress Syndrome; It’s Time to Accelerate Clinical Trials for COVID-19 Patients in Need

A new systematic review and meta-analysis of clinical studies using mesenchymal stromal cells (MSCs) led by a team at the Mayo Clinic, and including researchers from Emory, Duke, Case-Western, and the University of Miami, shows a trend toward improved outcomes and reduced mortality for patients with acute respiratory distress syndrome (ARDS)—a major complication for patients with COVID-19.

Read More


TEG test can identify undetected blood clots in COVID-19 ICU patients

Researchers at Baylor College of Medicine are recommending that all COVID-19 patients admitted to the ICU undergo a thromboelastography (TEG) to test for the risk of forming blood clots. This recommendation comes after they found that more than half of the patients tested under these same conditions developed clinically significant blood clots that went undetected using routine

Read More


Study identifies inhibition of Bruton tyrosine kinase as potential approach to treat severe respiratory distress in patients with COVID-19

Early data from a clinical study suggest that blocking the Bruton tyrosine kinase (BTK) protein provided clinical benefit to a small group of patients with severe COVID-19. Researchers observed that the off-label use of the cancer drug acalabrutinib, a BTK inhibitor that is approved to treat several blood cancers, was associated with reduced respiratory distress

Read More


A published trial on Convalescent Plasma in Covid-19 doesn’t show conclusive results but severely ill patients recovered five days faster

Infusions of antibody-rich blood plasma from people who have recovered from the coronavirus, so-called convalescent plasma, failed to make a difference in a study of hospitalized patients in China, researchers reported on Wednesday in the Journal of the American Medical Association. In a randomized trial involving 103 COVID-19 patients, convalescent plasma made no difference in

Read More


APPA: New effective treatment for harmful effects of neutrophils in inflammatory diseases found at the Liverpool University

New research conducted by the University of Liverpool and AKL Research and Development Ltd (AKLRD), published in Inflammopharmacology, highlights the potential benefits of a new drug treatment on the human body’s immune response in inflammation. In a number of inflammatory conditions, such as osteoarthritis, rheumatoid arthritis and, more recently, COVID-19, major complications and extensive tissue damage can occur

Read More


Lymphopenia, neutrophilia and cytokines in severe Covid-19 patients

The dynamic changes of lymphocyte subsets, neutrophils and cytokines profiles of patients with novel coronavirus disease (COVID-19) and their correlation with the disease severity has been studied in a paper recently published on EBioMedicine https://doi.org/10.1016/j.ebiom.2020.102763. Of the 40 COVID-19 patients enrolled, 13 severe cases showed significant and sustained decreases in lymphocyte counts, but increases in

Read More


Early Indicators: Investigational convalescent plasma is safe for patients with COVID-19

The first safety study communications overview, Early Safety Indicators of COVID-19 Convalescent Plasma in 5,000 Patients, for the national expanded access program for convalescent plasma has been published https://www.medrxiv.org/content/10.1101/2020.05.12.20099879v1 The report tells us: Mayo Clinic and collaborators reported safety data on the first 5,000 hospitalized patients transfused with investigational convalescent plasma as part of the

Read More


Face masks essential in combating spread of SARS-CoV-2 aerosols and droplets

SARS-CoV-2 spread occurs through the transmission of droplets and aerosols from infected people through speaking, breathing, coughing, and sneezing. Wearing masks can reduce the airborne transmission of the novel coronavirus, a new study finds. The research is published in the journal Science. The team of researchers at the University of California San Diego and the National Sun Yat-sen

Read More


Neutrophil Extracellular Traps are involved in Severe COVID-19 proteolytic storm

Neutrophil released NETs to control microbial/viral infections, could serve as a therapeutic target in coronavirus infections. In March this year, Dr. Knight and Kanthy of Michigan University observed a striking similarity between an autoimmune disease known as antiphospholipid syndrome (APS) and COVID-19. Both conditions appeared to involve blood clots in arteries, veins, and the microvasculature.

Read More


Type I and Type III Interferons – Induction, Signaling, Evasion, and Application to Combat COVID-19

In this review, published in Cell Host & Microbe, it’s described the recent progress in understanding of both type I and type III IFN-mediated innate antiviral responses against human coronaviruses and discussed the potential use of IFNs as a treatment strategy for COVID-19. Type I and type III IFNs establish the cellular state of viral

Read More


In Covid-19 neutrophils induce an imbalanced “proteolytic storm”, fighted by human plasma transfusion proteolytic cascades balancing.

In a recent Comment published on EBioMedicine entitled “COVID-19 as a STING disorder with delayed oversecretion of Interferon-beta”, Berthelot and Lioté suggests that SARS-CoV-2 firstly inhibits interferon release but the NETs self-DNA induces delayed activation of STING with“cytokine storm”, causing the combination of interstitial lung disease and inflammatory vasculopathy. The assumption that SARS-CoV-2 had no

Read More


Covid-19 critical conditions are due to neutrophils unfriendly fire inducing “proteolytic storm” and human plasma can be a fire hose.

In a paper just published on Preprints, REGENHEALTHSOLUTIONS Research Team shows that, in Covid-19 critically ill patients, serine proteases released by recruited neutrophils are responsible for endothelitis, NETosis, platelet activation, ULVWF multimers release, thrombi formation and MOF for viral sepsis. Based on Chinese CDCP report on COVID-19, 14% of patients presented severe disease and 5%

Read More


Newly discovered cell type plays crucial role in immune response to respiratory infections and explains how Covid-19 convalescent plasma helps to boost immune responses in virus-infected patients.

With a discovery that could rewrite the immunology textbooks, an international group of scientists, including the teams of Bart Lambrecht, Martin Guilliams, Hamida Hammad, and Charlotte Scott (all from the VIB-UGent Center for Inflammation Research) identified a new type of antigen-presenting immune cell. These cells, that are part of an expanding family of dendritic cells,

Read More


Convalescent antibodies are getting first-choice for Covid-19 treatment

Antibodies from blood donated by people who recovered from the illness and hyper-immunoglobulins are becoming treatments of choice for COVID-19, with recombinant polyclonal antibody approaches to follow. A group of US academic researchers has sparked a nationwide effort to encourage people who have recovered from COVID-19 to donate plasma, which will be used to treat patients across

Read More


Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19

In a paper recently published by a team of New York researchers Hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death. Hydroxychloroquine has been widely administered to patients with Covid-19 without robust evidence supporting its use. The association between hydroxychloroquine use

Read More


Covid-19 Treatment with a Triple combination of interferon beta-1b, lopinavir–ritonavir, and ribavirin

Effective antiviral therapy is important for tackling the coronavirus disease 2019 (COVID-19) pandemic. In this paper published on The Lancet the efficacy and safety of combined interferon beta-1b, lopinavir–ritonavir, and ribavirin for treating patients with COVID-19 was assessed. Methods This was a multicentre, prospective, open-label, randomised, phase 2 trial in adults with COVID-19 who were

Read More


Can COVID-19 Cause Sepsis? Explaining the Relationship Between the Coronavirus Disease and Sepsis

The rapid global spread of the novel coronavirus SARS–CoV–2 has caused societal, economic, and medical upheaval not seen since the 1918 influenza pandemic. As of May 9th, cases were confirmed in 203 countries, areas or territories, with over 3.9 million confirmed cases and over 275,000 deaths.  Further, many experts believe these numbers to be a

Read More


FDA Recommendations for Investigational COVID-19 Convalescent Plasma

FDA has issued guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. The guidance provides recommendations on the following: pathways for use of investigational COVID-19 convalescent plasma patient eligibility collection of

Read More


COVID-19 Convalescent Plasma Transfusion: European Commission support a study

EU CCP Database – Covid-19 convalescent plasma collection and transfusion in the EU The European Commission is working together with Member States, the European Blood Alliance (EBA), the European Centre for Disease Prevention and Control (ECDC) and other health professionals to support a study of convalescent plasma as a treatment for COVID-19 patients. The study complements the guidance issued

Read More


Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis

A high cumulative incidence of thrombotic complications was reported in critically ill patients with COVID-19 admitted to the intensive care units (ICUs) of three Dutch hospitals. The incidence was re-evaluated of the composite outcome of symptomatic acute pulmonary embolism (PE), deep-vein thrombosis, ischemic stroke, myocardial infarction and/or systemic arterial embolism in all COVID-19 patients admitted

Read More


Convalescent plasma can become first-choice treatment for Covid-19

Antibodies from blood donated by people who recovered from the illness and hyper-immunoglobulins are becoming treatments of choice for COVID-19, with recombinant polyclonal antibody approaches to follow. A group of US academic researchers has sparked a nationwide effort to encourage people who have recovered from COVID-19 to donate plasma, which will be used to treat patients across

Read More


Interactions between neutrophil extracellular traps and activated platelets enhance procoagulant activity. Possible role in Covid-19 complications

NETs played a pivotal role in the hypercoagulability of stroke patients. Strategies that prevent NET formation may offer a potential therapeutic strategy for thromboembolism interventions in Covid-19 patients. Sivelestat, anti-MMP9 antibody, and APC inhibit the cytotoxic effects of NET to protect ECs and decrease PCA, suggesting their critical role in preventing thrombotic complications in atherosclerosis

Read More


EMA warns against using unproven cell-based therapies

EMA’s Committee for Advanced Therapies (CAT) is advising patients and the general public against using unregulated cell-based therapies which may not be safe or effective. The CAT’s advice is in response to individuals, companies and hospitals promoting unproven cell-based therapies as cures for a broad range of conditions including cancer, cardiovascular diseases, autism,cerebral palsy, muscular

Read More


Overview of convalescent plasma therapeutic use in Covid-19

An extensive overview of convalescent plasma therapeutic use in Covid-19 has just been published on JAMA 30 April. The analysed points are the following: need of randomised controlled trials: Without randomized controlled trials, researchers can’t be sure whether patients recovered because of an experimental therapy or in spite of it. Yet virtually everything that’s known

Read More


A SARS-CoV-2 protein interaction map reveals targets for drug repurposing

The novel coronavirus SARS-CoV-2, the causative agent of COVID-19 respiratorydisease, has infected over 2.3 million people, killed over 160,000, and causedworldwide social and economic disruption.There are currently no antiviral drugs with proven clinical efficacy, nor are there vaccines for its prevention, and these efforts are hampered by limited knowledge of the molecular details of SARS-CoV-2

Read More


In Covid-19 recovered patients, South Korean KCDC experts found false positives, not reinfections

South Korea’s infectious disease experts said Thursday that dead virus fragments were the likely cause of over 260 people here testing positive again for the novel coronavirus days and even weeks after marking full recoveries. Oh Myoung-don, who leads the central clinical committee for emerging disease control, said the committee members found little reason to

Read More


Convalescent plasma for the prevention and treatment of COVID-19. Why to use and When ?

Data from rigorously controlled clinical trials of convalescent plasma are few, underscoring the need to evaluate its use objectively for a range of indications (e.g., prevention vs treatment) and patient populations (e.g., age, comorbid disease). An overview of convalescent plasma, from evidence of benefit, regulatory considerations, logistical work flow and proposed clinical trials have been

Read More


DARPA-funded microchip technology optimizes convalescent plasma therapy for COVID-19 patients

A consortium of California scientists from government, academia and business today published an initial manuscript describing a novel approach to prepare convalescent plasma for COVID-19 patients in BioRxiv. In the paper, senior author Saahir Khan, MD, PhD, from the University of California, Irvine Department of Medicine, reports the use of a new and more accurate way

Read More


What is required to prevent a second major outbreak of SARS-CoV-2 upon lifting the quarantine of Wuhan city, China

This paper aims to determine to what level of the two commonly used control measures, social distancing and facial mask usage, are necessary to prevent a resurgence of the epidemic due to eitherresidual active cases in Wuhan or imported cases after lifting the quarantine, examining in a model six proposed dates for quarantine lifting. The

Read More


New clinical trial launches to test efficacy of cell therapy for severe COVID-19 cases

After a lightening round of proposals and reviews, an international team of scientists led by Dr. Camillo Ricordi was granted immediate FDA authorization for a 24-patient clinical trial to test the safety and exploratory efficacy of umbilical cord-derived mesenchymal stem cells (UC-MSCs) to block the life-threatening lung inflammation that accompanies severe cases of COVID-19. We are very

Read More


Chinese scientists seeking potential COVID-19 treatment find ‘effective’ antibodies in convalescent plasma

A team of Chinese scientists has isolated several antibodies that it says are “extremely effective” at blocking the ability of the new coronavirus to enter cells, which eventually could be helpful in treating or preventing COVID-19. There is currently no proven effective treatment for the disease, which originated in China and is spreading across the

Read More


Controlling Covid-19 using a mobile app to trace close proximity contacts

A team of medical researchers and bioethicists at Oxford University has published results in Science that furthers  understanding of Covid-19 transmission. The evidence is enabling several international partners, including the Norwegian Institute of Public Health (FHI) and NHSX, a joint unit comprised of teams from NHS England and the UK’s Department of Health & Social Care, to assess the

Read More


Can convalescent plasma help saving severe Covid-19 patients life ?

Wuhan researchers have published a non peer-reviewed anedoctical clinical paper on a pilot study using convalescent plasma in 10 critical Covid-19 patients In this study, ten severe patients confirmed by real-time viral RNA test were enrolled prospectively. One dose of 200 mL convalescent plasma (CP) derived from recently recovered donors with the neutralizing antibody titers

Read More


A validated composite model to predict risk of curve progression in adolescent idiopathic scoliosis

A newly published study on @EClinicalMed by @CUHKofficial aims to formulate a composite model composed of clinical parameters and circulating markers in the prediction of curve progression. In adolescent idiopathic scoliosis (AIS), the continuous search for effective prognostication of significant curve progression at the initial clinical consultation to inform decision for timely treatment and to

Read More


Hematopoietic stem cell marker: A key player in the ontogeny of hematopoiesis

A group of researchers at Osaka University revealed that endothelial cell-selective adhesion molecule (ESAM), a surface marker for hematopoietic stem cells (HSCs) and vascular endothelial cells (ECs), played an important role in the ontogeny of hematopoiesis in mice, particularly in the development of adult-type erythropoiesis. Their research results were published in Stem Cell Reports. In hematopoiesis,

Read More


Current Immunotherapy: Progress With Adoptive Cellular Therapies and Combinations

Source Targeted Oncology The clinical development and application of cancer immunotherapy over the past decade has translated the long-standing knowledge of the close relationship between cancerous tissues and lymphoid immune cells, dating back to the late 19th century.1,2 Today, cancer immunotherapies, all of which recruit the body’s own immune system to target and eliminate cancer cells,

Read More


Engineered 3D Polymer and Hydrogel Microenvironments for Cell Culture Applications

In the recently published ‘Engineered 3D Polymer and Hydrogel Microenvironments for Cell Culture Applications,’ authors Daniel Fan, Urs Staufer, and Angelo Accardo explore the world of bioengineering and microenvironments, reviewing the best types of methods, materials, and challenges that must be met. Material properties are one of the most highly discussed topics today in 3D

Read More


Production and Quality Requirements of Human Platelet Lysate: A Position Statement from the Working Party on Cellular Therapies of the International Society of Blood Transfusion

Human platelet lysate (HPL), rich in growth factors, is an efficient alternative supplement to fetal bovine serum (FBS) for ex vivo propagation of stromal cell-based medicinal products. Since 2014, HPL has been a focus of the Working Party for Cellular Therapies of the International Society of Blood Transfusion (ISBT). Currently, as several Good Manufacturing Practice

Read More


The Alliance for Regenerative Medicine Outlines Recommendations for Increasing the Number of European-Based ATMP Clinical Trials

Europe has become less competitive than other regions in attracting new ATMP clinical trials. Faster and more streamlined review processes for clinical trials by regulatory authorities are fundamental to increase clinical research and development in Europe. There is considerable country-to-country variability within Europe: the UK has the highest absolute number of new ATMP clinical trials,

Read More


NIH launches new collaboration with Bill & Melinda Gates Foundation to develop gene-based cures for sickle cell disease and HIV on global scale

Source NIH Initial investment aims to advance accessible and scalable candidate interventions into clinical trials within 10 years. The National Institutes of Health plans to invest at least $100 million over the next four years toward an audacious goal: develop affordable, gene-based cures for sickle cell disease (SCD) and HIV. The Bill & Melinda Gates

Read More


NIH researchers create new viral vector for improved gene therapy in sickle cell disease

Source NIH ‘Forward-oriented’ design might boost treatment effectiveness and broaden use. Researchers at the National Institutes of Health have developed a new and improved viral vector—a virus-based vehicle that delivers therapeutic genes—for use in gene therapy for sickle cell disease. In advanced lab tests using animal models, the new vector was up to 10 times

Read More


RESTORE Large Scale Research Initiative community presents 1st Advanced Therapies Science Meeting (1st ATSM) in Berlin, 25-26 November 2019

What are the research challenges slowing development of curative treatments and what are the roadblocks for the wider adoption of Advanced Therapies in clinical routine? Join the conversation at the1st Advanced Therapies Science Meeting (1st ATSM)in Berlin, 25-26 November 2019 to explore the latest trends in the field and to discuss the Advanced Therapies Roadmap 2030 that

Read More


Future and Emerging Technologies Flagships and Large Research Initiatives

European Commission, Digital Single Market has published a new Factsheet/Infographic on FET Flagships and Large Research Initiative. These visionary, long-term, large-scale research initiatives address major science and technology challenges in Europe. They involve hundreds of research teams with the aim of boosting the EU’s scientific and industrial landscape.


A 3D printer to produce human organs in space? Discover the experiments taking place in zero-gravity

Source Euronews Euronews space correspondent and European Space Agency (ESA) astronaut Luca Parmitano has been in space for a month now. His first mission was to “catch a Dragon” – a cargo vehicle which brings payloads for astronauts onboard the International Space Station (ISS). Once the dragon was “captured”, Luca and his team received new scientific equipment to start working on

Read More


Health Technology Assessment of Gene Therapies in Europe and the USA: Analysis and Future Considerations

Gene therapies constitute a new concept of transformative therapies, administered once in a lifetime. The value assessment of these innovative therapies constitutes a challenge for health technology assessment (HTA) bodies. The HTA reports for all seven gene therapies that have to date been granted a market authorization in the European Union (EU) and/or the United

Read More


Heart regeneration: Scientists uncloak one of nature’s deepest secrets

Scientists at the University of Texas Southwestern have uncloaked the molecular mechanisms underlying heart regeneration in the only mammals currently known to regrow a significant portion of their hearts after injury: neonatal mice. These newborns have long held the secret to regenerating approximately 15 percent of their ventricular tissue, a capability that occurs within a fleeting window of about

Read More


Gene Therapy Shows Promise for AADC Deficiency But Requires Early Diagnosis, Study Says

Early clinical trials of a gene therapy for aromatic amino acid decarboxylase (AADC) deficiency have yielded encouraging results for its safety and efficacy, a study highlights. But researchers call attention to the importance of a timely diagnosis for treatment success, as only early interventions could fully prevent long-term brain damage and other outcomes. Their study, “Aromatic amino

Read More


Immunotherapy for Pediatric Solid Tumors: What’s the Latest?

Immunotherapy can be effective in treating certain types of pediatric blood cancers, but researchers are still exploring how this type of treatment could work for pediatric solid tumors. In clinical trials, scientists are combining immunotherapy agents in an effort to jump-start the immune system against pediatric solid tumors. Source DANA-FARBER Cancer Institute New treatments that

Read More


3D printed salt template for bioresorbable bone implants

With the help of a 3D printed salt template, ETH researchers have succeeded in producing magnesium scaffolds with structured porosity that are suitable for bioresorbable bone implants. For the treatment of complex bone fractures or even missing bone parts, surgeons typically deploy metal implants. In this context, an attractive alternative to the traditional materials like

Read More


Using Electroporation and continuous-flow electrotransfection to Streamline Manufacturing of Next-Generation Cellular Therapies

A promising new treatment for cancer patients has received approval from the Centers for Medicare and Medicaid Services, paving the way for more patients to get the treatment known as CAR T-cell therapy. While this decision will likely expand access, particularly for some lymphoma and leukemia patients, treatment remains prohibitively expensive, prompting some patients to opt for experimental rather

Read More


Deep learning enables scientists to identify cancer cells in blood in milliseconds

Technique could allow cells to be extracted in real time, help prevent cancer from spreading Researchers at UCLA and NantWorks have developed an artificial intelligence-powered device that detects cancer cells in a few milliseconds — hundreds of times faster than previous methods. With that speed, the invention could make it possible to extract cancer cells from blood immediately after

Read More


$9 million grant funds trial of CAR T-cell therapy for metastatic breast cancer

California Institute for Regenerative Medicine awarded a $9.28 million grant will support a clinical trial at City of Hope to evaluate chimeric antigen receptor T-cell therapy for patients with HER2-positive breast cancer that spread to the brain. About 20% of breast cancers are HER2-positive, and nearly half of women with this type of breast cancer develop brain

Read More


Now Available: ARM’s Searchable, Downloadable Database of Near-Term Anticipated RM/AT Data Readouts and Other Clinical Events

This new resource provides clear, simplified information on indication-, technology-, or company-specific upcoming data readouts and other clinical events. ARM has carefully curated all entries to ensure they fall within our narrowly defined criteria for regenerative medicines, and includes many milestones which are not reported in other clinical trial datasets, including anticipated product approvals. Currently, the database includes 188 anticipated events and includes a search-and-download function, and

Read More


Superstar Athletes Popularize Unproven Stem Cell Procedures

Treatments for baseball pitcher Max Scherzer and other pros may mislead fans about costly, controversial, unapproved stem cell shots. Source KHN Baseball superstar Max Scherzer — whose back injury has prevented him from pitching for the Washington Nationals since he last played  on July 25 — is the latest in a long list of professional athletes to embrace unproven stem cell

Read More


Centers for Medicare & Medicaid Services (CMS) Make CAR T-Cell Cancer Therapy Available to Medicare Beneficiaries Nationwide

Decision ensures consistency in access to the innovative new cancer therapy, and CMS is working closely with sister agencies to monitor outcomes for patients receiving the therapy Today the Centers for Medicare & Medicaid Services (CMS), under the leadership of President Trump and Secretary Azar, finalized the decision to cover FDA-approved Chimeric Antigen Receptor T-cell, or “CAR

Read More


Masters of Science (MSc) degree in ATMPs has opened to enrolment at the University of Manchester

Under the guidance of the iMATCH team,  a new Masters of Science (MSc) degree in Advanced Therapy Medicinal Products (ATMPs) has opened to enrolment at the University of Manchester. This course is believed to be a world first focussing on this rapidly evolving area of medicine which is increasingly being used to treat a broad

Read More


RESTORE Large Scale Research Initiative presents 1st Advanced Therapies Science Meeting

Shifting from treating symptoms to curing chronic diseases by making the transformative promise of Advanced Therapies a reality for the benefit of patients, that is the vision of the international project RESTORE Health by Advanced Therapies. For genetic diseases, immune diseases, cancer and tissue injury potential cures through Advanced Therapies exist – they are reality,

Read More


bluebird bio Announces EU Conditional Marketing Authorization for ZYNTEGLO™ (autologous CD34+ cells encoding βA-T87Q-globin gene) Gene Therapy for Patients 12 Years and Older with Transfusion-Dependent β-Thalassemia Who Do Not Have β0/β0 Genotype

ZYNTEGLO is the first gene therapy approved for transfusion-dependent β-thalassemia (TDT) European marketing authorization for ZYNTEGLO follows the fastest assessment of an advanced therapy medicinal product (ATMP) as part of the European Medicines Agency’s Priority Medicines (PRIME) program ZYNTEGLO is bluebird bio’s first gene therapy to gain regulatory approval bluebird bio, Inc. announced today that the European Commission (EC)

Read More


Are industry-funded charities promoting “advocacy-led studies” or “evidence-based science”?: a case study of the International Life Sciences Institute

Source The Guardian International Life Sciences Institute used by corporate backers to counter public health policies, says study An institute whose experts have occupied key positions on EU and UN regulatory panels is, in reality, an industry lobby group that masquerades as a scientific health charity, according to a peer-reviewed study. The Washington-based International Life Sciences

Read More


Advanced Therapies News

Source ARM Organovo Collaborates With MCRI and Leiden University Medical Center to Develop Stem Cell-Based Bioprinted Tissue Treatments for Kidney DiseaseMay 30, 2019 – (Organovo) – This multi-organizational effort integrates Organovo’s leading bioprinting platform with MCRI’s advanced stem cell differentiation technology and LUMC’s cell lines and clinical expertise.  The collaboration has been made possible through generous

Read More


Advanced therapies and carT cells in the next IMI2 calls

Future topics To give potential applicants as much time as possible to form consortia and prepare their proposals, IMI regularly publishes information on possible future topics well in advance of the official Call launch. To ensure you get the latest information on forthcoming Calls, sign up to our newsletter, follow us on Twitter, or join our LinkedIn group.

Read More


ICER Comments on the FDA Approval of Zolgensma for the Treatment of Spinal Muscular Atrophy

In light of additional data from ongoing trials of onasemnogene abeparvovec (Zolgensma®, Novartis/AveXis), as well as the treatment’s final FDA label and just-announced launch price, the Institute for Clinical and Economic Review (ICER) today published an addendum to its Final Evidence Report on treatments for spinal muscular atrophy (SMA). Since the publication of ICER’s Final Evidence Report on

Read More


Vascularized Kidney Tissue Engineered by WFIRM Scientists

Wake Forest Institute for Regenerative Medicine (WFIRM) researchers have shown the feasibility of bioengineering vascularized functional renal tissues for kidney regeneration, developing a partial augmentation strategy that may be a more feasible and practical approach than creating whole organs. In the proof-of-concept study published online this month in Acta Biomaterialia journal, the scientists created a novel

Read More


5G In Healthcare

Source: TMF The next telecommunication revolution is just around the corner: the promises of high bandwidth, low latency and low-power-low-cost of 5G will open the gate to a flood of new inventions and the implementation of ideas, which have already been for long in the public consciousness – such as stable augmented reality or truly

Read More


Most Healthcare, Fitness Tracker, And Wellness Apps Are Not Covered By HIPAA And HHS’s New Faqs Makes That Clear

Individuals who use healthcare apps such as fitness trackers, weight loss, wellness, exercise, etc., BEWARE!A couple of recent developments have highlighted the fact that most apps are not subject to HIPAA, which means that with broadly-worded privacy policy these healthcare apps can and do readily share healthcare and other data collected by the apps with third

Read More


Artificial intelligence could select heart failure patients for expensive treatment

Machine learning algorithm predicts sudden death in heart failure patients for the first time Artificial intelligence (AI) has shown promise to select heart failure patients for expensive treatments to prevent lethal arrhythmias, reports a study presented today at ICNC 2019. (1) The study is the first to use a machine learning algorithm to predict sudden

Read More


German Ethics Council: germline interventions currently too risky, but not ethically out of the question

Last year, the birth of the first genetically modified babies shook the world. The German Ethics Council now presents a comprehensive ethical investigation into possible interventions in the genome of human embryos or germ cells. The Council does not deem the human germline to be inviolable. It does, however, consider germline interventions to be ethically

Read More


JAMA Counteracting Health Misinformation A Role for Medical Journals?

A recent editorial in the Journal of the American Medical Association (JAMA) addresses the growing problem of medical misinformation, such as anti-vaccine views, fake treatments, unproven alternative products and services, and others. The authors, Armstrong and Naylor, make some good recommendations, but unfortunately are about 20 years behind the times when it comes to confronting scientific misinformation.

Read More


USC-led advance in groundbreaking cancer treatment eliminates severe side effects

An advance in the groundbreaking cancer treatment known as CAR T-cell therapy appears to eliminate its severe side effects, making the treatment safer and potentially available in outpatient settings, a new USC study shows. “This is a major improvement,” said Si-Yi Chen of the USC Norris Comprehensive Cancer Center, professor in the Department of Molecular Microbiology

Read More


Synthetic Speech Generated from Brain Recordings

A state-of-the-art brain-machine interface created by UC San Francisco neuroscientists can generate natural-sounding synthetic speech by using brain activity to control a virtual vocal tract – an anatomically detailed computer simulation including the lips, jaw, tongue and larynx. The study was conducted in research participants with intact speech, but the technology could one day restore the

Read More


Augmented Reality: The Future of Medicine

Augmented Reality can change brain surgery thanks to powerful diagnostic platforms, revolutionize radiology, and open new doors to reconstructive surgery. Augmented Reality (AR), also known as spatial computing –a merging of digital and physical spaces,– is one of the current technology trends that, together with Virtual Reality (VR) and Mixed Reality (MR), is changing all industries, includinghealthcare and medical education. 

Read More


Pig brains kept alive outside body for hours after death

Researchers have developed a high-tech support system that can keep a large mammalian brain from rapidly decomposing in the hours after death, enabling study of certain molecular and cellular functions. With funding through the National Institutes of Health BRAIN Initiative, researchers developed a way to deliver an artificial blood supply to the isolated postmortem brain of

Read More


Gene therapy restores immunity in infants with rare immunodeficiency disease

NIH scientists and funding contributed to development of experimental treatment A small clinical trial has shown that gene therapy can safely correct the immune systems of infants newly diagnosed with a rare, life-threatening inherited disorder in which infection-fighting immune cells do not develop or function normally. Eight infants with the disorder, called X-linked severe combined

Read More


Two Patients Treated with CRISPRed Cells in Immunotherapy Trial

Researchers have infused cells edited using CRISPR-Cas9 into two patients in a trial conducted at the University of Pennsylvania, NPR reports today (April 16). A university spokesperson confirmed in an emailed statement to The Scientist that the trial is underway and that two patients, one with multiple myeloma and one with sarcoma, have been treated so far. The study is

Read More


Study: Half of people on statins don’t hit healthy cholesterol levels

Cardiovascular disease (CVD) remains the in the United States. And one of the most effective preventive measures to lower the risk of a CVD event are statins — a class of cholesterol-lowering medications. It’s well established that statins save lives, but a recent study finds that even after two years, half of all people prescribed statins don’t achieve healthy cholesterol levels.

Read More


RESTORE Consortium – CURING CHRONIC DISEASES BY “LIVING DRUGS”

OVERVIEW Shifting from treating symptoms to curing chronic diseases by making the transformative promise of Advanced Therapies a reality for the benefit of patients and society and by making Europe a spearhead of Advanced Therapies in Science,Clinics and Biomedical Industry, that is the vision of the international project RESTORE Health by Advanced Therapies, coordinated by

Read More


Researchers conduct largest study of childhood cancer after conception by IVF

In the past three decades, in vitro fertilization (IVF) has gone from an experimental procedure to being more common. Pregnancies enabled by IVF frequently have more difficulties, with children born earlier and smaller even among singleton births. University of Minnesota researchers conducted the largest study of childhood cancer after conception by IVF to date. This

Read More


First gene therapy to treat rare blood disease nears European approval

The first gene therapy to treat a rare blood disorder is one step closer to approval Friday following a recommendation by European officials. Lentiglobin, the gene therapy for beta-thalassemia developed by Cambridge, Mass.-based Bluebird Bio, was recommended for approval by the Committee for Medicinal Products for Human Use (CHMP), the drug-reviewing arm of the European Medicines Agency.

Read More


Launch of six European initiatives with potential for transformational impact on society and the economy

The European Commission is announcing the winners of a pan-European competition open to researchers addressing grand scientific and technological challenges that could change our future. The six preparatory actions now launched will have one year to prepare science and technology agendas in areas of strategic importance for Europe. These may contribute to defining and launching

Read More


Stem Cell Therapy for Heart Failure

With modern, guideline-directed therapy,1 which includes angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), β-receptor blockers, mineralocorticoid receptor blockers, and angiotensin receptor neprilysin inhibitors, up to 40% of patients with dilated cardiomyopathy (heart failure with reduced ejection fraction) may experience a return of left ventricular ejection fraction (LVEF) and ventricular geometry to normal.2 This encouraging result

Read More


Google AI research group shows that AI can improve physicians’ diagnostic accuracy.

As artificial intelligence continues to evolve, diagnosing disease faster and potentially with greater accuracy than physicians, some have suggested that technology may soon replace tasks that physicians currently perform. But a new study from the Google AI research group shows that physicians and algorithms working together are more effective than either alone. It’s one of

Read More


Study finds old brains still make neurons

https://www.nature.com/articles/s41591-019-0375-9 Reports of old brains’ decrepitude have been greatly exaggerated, scientists reported on Monday, unveiling results that contradict a much-discussed 2018 study and instead support the idea that human gray matter is capable of generating new neurons up to the ninth decade of life. The research, published in Nature Medicine, also found that old brains from

Read More


A special edition of The American Statistician presents over 40 papers on “Statistical inference in the 21st century: a world beyond P < 0.05”

Statistical significance has become an infallible doctrine of scientific research. However, many scientists and statisticians argue that long-held beliefs about statistical significance have, in fact, harmed the scientific community. In hypothesis testing, the p-value gives the probability or likelihood that the null hypothesis is true and is frequently used as a measure of “statistical significance.”

Read More


Giant study shows Apple Watch can spot heart rhythm changes — but it’s far from ‘medical-grade technology’

New results of a gigantic study testing how well the Apple Watch detects important heart-rhythm changes offer a tantalizing glimpse of how consumer devices might change medicine and lead to new ways to conduct science — but little more. Unfortunately, the data don’t tell us much about whether anyone should buy an Apple Watch, or

Read More


Large Scale Research Initiative RESTORE New presentation

SUPPORT RESTORE AND DIFFUSE INFORMATION USING DOWNLOAD MATERIAL AT https://www.restore-h2020.eu/documents/download/restore_pr_slides_short_update_14_03_2019.pdf Large Scale Research Initiative RESTORE is a “place” where medicine, basic research, technology development and engineering meet, communicate and work together. Advanced Therapies (Advanced Therapies Medicinal Products and Biologised Medical Devices – ATMP/bio-MD) are a potential game changer in health care: They aim to transform

Read More


The human reference genome falls short in ways that have become embarrassing, misleading, and emblematic of the white European dominance of science.

Here’s why that’s undermining personalized medicine In a paper published last week, scientists led by Dr. Pui-Yan Kwok of the University of California, San Francisco, analyzed 154 genomes from 26 ethnic populations, from Han Chinese and Tuscans to Yoruba, Esan, Puerto Ricans, and Peruvians. They found 60 million bases in one or more of these populations

Read More


Scientists find method to boost CRISPR efficiency

Discovery made while editing genetic defect behind Duchenne muscular dystrophy Scientists have developed a method to boost the efficiency of CRISPR gene editing in Duchenne muscular dystrophy (DMD), according to a study that could have implications for optimizing gene therapies for other diseases. The finding stemmed from research at UT Southwestern in which a single-cut gene-editing

Read More


Scaffold-free cell patches possible with simple protocol for engineered adipose-derived stem cells

Cell sheets have previously shown greater efficacy for tissue repair than injections of single stem cells. New research conducted by scientists at the Los Angeles Biomedical Research Institute and Emmaus Life Sciences, Inc. (both CA, USA) has demonstrated the possibility of producing scaffold-free engineered cell sheets. These cell ‘patches’ could enable better organ repair follow

Read More


Today marks the official start of RESTORE – Health by Advanced Therapies, entering the preparatory phase to become a Large-Scale Research Initiative.

Advanced Therapies are new treatment modalities (e.g. cell and gene therapy, tissue engineering) that aim to consign the never-ending treatment of chronic ailments to the past and instead offer sustained improvement and even cures. To enable Europe to become a competitive leader in this field, RESTORE is defining an Advanced Therapies roadmap 2021-2030 for Europe.

Read More


Unique augmented reality concept for image-guided minimally invasive therapies

February 27 2019 P.M.Fornasari At the MWC Barcelona, one of the largest mobile events in the world, Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology today unveiled a unique mixed reality concept developed together with Microsoft Corp. (NASDAQ: MSFT) for the operating room of the future. Based on the state-of-the-art technologies

Read More


How gut bacteria controls gene expression through “interspecies communication”

Highlights •Microbiome-derived NO promotes widespread S-nitrosylation of the host proteome •Interspecies S-nitrosylation regulates miRNAs, gene expression and host development •Microbiota control host function by shaping the post-translational landscape Summary Bioactive molecules can pass between microbiota and host to influence host cellular functions. However, general principles of interspecies communication have not been discovered. We show here

Read More


RESTORE encourages your contribution to promote the project. Support RESTORE consortium

Advanced Therapies (Advanced Therapies Medicinal Products and Biologised Medical Devices – ATMP/bio-MD) are a potential game changer in health care: They aim to transform the current focus on “treatment of disease” into one that concentrates on “regeneration of health”. The unifying goal of RESTORE is the implementation of newly developed Advanced Therapies in clinical routine

Read More


‘Off-the-shelf’ CAR-Ts have an important role to play – but are they ready for prime time?

Allogeneic CAR-Ts could serve an important niche – particularly for patients who can’t receive autologous CAR-Ts – but the earliness of the data makes conclusions tough to draw. Since their transition from small, academic clinical trials to commercial production, CAR-T cell therapies have won recognition as a novel and highly effective therapeutic modality, particularly in

Read More


AI applications in healthcare grow, opening channel prospects

The hype around AI applications in healthcare spans decades, but the latest wave of AI tech suggests real-world traction. Artificial intelligence is already promising big things at Massachusetts General Hospital and Brigham and Women’s Hospital in Boston, where researchers have been building machine learning models over the past couple of years. Those models now help

Read More


RHS is supporting RESTORE large scale research initiative

REGENHEALTHSOLUTIONS is a strong supporter of RESTORE, one of the six large scale research initiatives selected by European Commission in areas from health and energy to artificial intelligence and cultural heritage—to compete to become one of its next billion-euro ‘flagship’ science initiatives. On 1 March, each team will receive €1 million (US$1.1 million) to develop a

Read More


NIAID announced that the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4) has begun to enroll hospitalized adults with COVID-19 requiring supplemental oxygen.

The NIAID-sponsored trial will enroll up to 1,500 patients at approximately 100 sites in the United States and other countries. Participants will be assigned at random to one of two treatment arms of equal size. One group will receive both dexamethasone, a corticosteroid available as a generic drug, and remdesivir, a broad-spectrum antiviral discovered and

Read More