To create a clearer picture of the risks that these interventions pose and underscore the need for increased FDA oversight, The Pew Charitable Trusts gathered reports of adverse events (AEs) linked to unapproved SCRIs administered outside of clinical trials. ![]() However, adverse events associated with any medical product are generally underreported, and providers of unapproved treatments are particularly unlikely to report patient harm to regulators or disclose such cases through public reporting- making it more difficult for the agency to prioritize its enforcement actions, and also leading policymakers and the public to underestimate the risks of these interventions. 3įDA uses reports of adverse events-undesirable patient experiences associated with the use of medical treatments-to help identify potentially dangerous products meriting further investigation. ![]() FDA has given manufacturers and marketers of SCRIs until May 31, 2021, to come into compliance with the agency’s regulations governing human cell and tissue products, including submitting those products for FDA review when necessary. 2 The products made and sold by these businesses typically use cells from the patient’s own body or from donated amniotic fluid, placental tissue, or umbilical cord blood, among other birth-derived cells and tissues. offer unapproved stem cell and regenerative medicine interventions (SCRIs) for conditions such as Alzheimer’s disease, muscular dystrophy, autism, spinal cord injuries, and, most recently, COVID-19. 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 pain, and even death. Stem cell products and other regenerative therapies have significant potential to treat traumatic injuries and serious diseases.
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