Patients have been blinded or have experienced retinal detachments after treatment with so-called stem cell therapies such as intravitreal injections of autologous stem cells that are not FDA approved for many ocular conditions across the US and that were marketed directly to patients. Currently, the FDA has regulatory authority over such companies and since June
Unproven regenerative medical products have led to infections, disabilities and deaths Overview Stem cell products and other regenerative therapies have significant potential to treat traumatic injuries and serious diseases. Although some have earned approval from the Food and Drug Administration, most have not, and many of these unapproved interventions have led to life-threatening infections, chronic
Women and children bear substantial morbidity and mortality as a result of armed conflicts. This paper published in The Lancet focuses on the direct (due to violence) and indirect health effects of armed conflict on women and children (including adolescents) worldwide. It was estimate that nearly 36 million children and 16 million women were displaced
A new paper published on JAMA by Peter W. Marks and Stephen Hahn of FDA The products administered by clinics under the broad rubric of regenerative medicine include those derived from individuals’ own bone marrow or fat, those derived from birthing tissues such as placenta or cord blood obtained from a donor unrelated to the
As the COVID-19 pandemic enters its third month, businesses in the United States are marketing unlicensed and unproven stem-cell-based “therapies” and exosome products that claim to prevent or treat the disease. In Cell Stem Cell on May 5, bioethicist Leigh Turner describes how these companies are “seizing the pandemic as an opportunity to profit from hope and
Scientists and international bodies including Stem Cells Australia, the International Society for Stem Cell Research, the International Society for Cell and Gene Therapy and EuroStemCell have raised the alarm about the marketing of unproven therapies during the pandemic, warning of damage to patients and to the credibility of the field. Source The Medical Republic Professor Daniel
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
In response to the global coronavirus disease 2019 (COVID-19) emergency, clinical trial research assessing the efficacy and safety of clinical candidate interventions to treat COVID-19 are emerging at an unprecedented rate. As of April 21, 2020, well over 500 clinical trials have been registered at the various international and national clinical trial registry sites. Most
Posts which promote “fake or ineffective treatments” for COVID-19 and deny “expert guidance” on the coronavirus are to be removed. Source Sky News Tweets that put people at risk of contracting the COVID-19 coronavirus as it rapidly spreads across the globe are to be removed by Twitter to help the public get accurate information and
ISSCR has become aware of recent claims that stem cells can be used to treat people infected with COVID-19. While stem cell research shows promise for numerous diseases and conditions, there currently are no approved stem cell-based approaches for the prevention and treatment of COVID-19 infection. The ISSCR is a vocal and active opponent of the premature
