In this interview with Dr. Riam Shammaa, Medical Director at the Canadian Centres for Regenerative Therapy (CCRT), we discuss FDA regulation of human cells, tissues, and cellular and tissue-based products (HCT/P’s), as well as the difference between 351 and 361 products. This is a timely interview, because the U.S. FDA recently filed two federal complaints seeking “permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.”
The first FDA injunction was against US Stem Cell Clinic LLC of Sunrise, Florida, its CSO Kristin Comella and Co-Owner Theodore Gradel. The second injunction was against Drs. Elliot Lander and Mark Berman, who control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center.
While the FDA has a critical role in market oversight, individual market participants are also responsible for understanding the regulatory framework affecting the sale, distribution, and utilization of stem cell products. This interview is aimed to help you understand the FDA framework affecting HCT/Ps within the U.S, as well as the framework and recommendations implemented by Health Canada.