More on The FDA’s Stem Cell Public “Workshop”: Stem Cell Clinical Trials aren’t the Answer for Everyone
Not unexpectedly, the organizing theme of the FDA’s Stem Cell workshop was that patients should only be able to receive their own stem cells for non-homologous use in FDA approved clinical trials until FDA marketing approval (i.e., until a New Drug Application is granted for some non-homologous use). I’ve been involved in legal/policy issues relating to clinical trials for a long time. I understand that clinical trials is the standard of care for patients when FDA approved treatments (on or…