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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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,

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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,

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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.

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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

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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

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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

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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

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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

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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

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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

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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.

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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

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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

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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%

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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,

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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,

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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,

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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

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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

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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,

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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$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

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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

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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

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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

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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

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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,

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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)

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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

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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

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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.

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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

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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

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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

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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

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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

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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

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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.

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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

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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

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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. 

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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

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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

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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

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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.

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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

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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

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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.

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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

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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

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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

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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

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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.”

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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

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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

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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

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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

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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

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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.

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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

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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

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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

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‘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

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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

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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

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