Legal Policy Report No. 17 September 2013 The FDAs Misguided Regulation of Stem-Cell Procedures: How Administrative Overreach Blocks Medical Innovation Richard A. Epstein, Visiting Scholar, Manhattan Institute Executive Summary The current biomedical revolution has its most tangible application to ordinary people in the new cutting-edge techniques devised by individual physicians for the cure and palliation of chronic and degenerative diseases. The rate of advance in this area is a testimony to the creative forces unleashed by the decentralized control over medical procedures. But that progress is now threatened by the federal Food and Drug Administration (FDA), which seeks to extend its statutory authority to subject these practices to the same oversight that is given to large drug manufacturers in the design and production of new products for the mass market. One area over which the FDA has asserted its power is private adult stem-cell treatment, which has developed treatment protocols that were not possible a generation, or even a decade, ago. The FDA has taken the aggressive position that it has oversight authority over any stem-cell procedure that reinjects harvested stem cells into the same person from whom they were removed, so long as those cells were grown and cultured … Continue reading →

Cord Blood Registry Call our Specialists Meet Heather Connecting clients to the regenerative potential of stem cell medicine Cord blood has been used for 20 years to treat more than 80 serious diseases.34 Successful treatments have paved the way for further research and today, FDA-regulated clinical trials are exploring the use of a childs own stem cells for conditions that currently have no cure. Several of these groundbreaking trials only use cord blood stem cells processed by Cord Blood Registry as a way of ensuring consistent quality. That means, saving with Cord Blood Registry gives families access to more uses and treatments. Cord blood stem cells are currently being evaluated as potential treatment for: Learn more about CBR's role in furthering stem cell research through the CBR Center for Regenerative Medicine. Dr. Michael Chez, director of pediatric neurology at Sutter Medical Center, is leading a landmark FDA-regulated clinical trial to test the use of a childs own umbilical cord blood as a therapy to improve language and behavior in children with autism who have no obvious cause for the condition such as a known genetic syndrome or brain injury. Learn more A new clinical trial will investigate using a childs … Continue reading →