Another FDA Announcement for Regulation of Stem Cell Treatments
[Thursday, April 04, 2019]

This week FDA reiterated its goal to enforce strict regulation of all stem cells treatment. In the strongly worded blog, FDA emphasized that autologous stem cell treatments are also regulated under the regulations for INDs and BLA and that it is false to claim that FDA jurisdiction over such treatments is not applicable. FDA also emphasized that it is looking to create special product approval pathways tailored towards smaller companies and physician practices offering lower risk stem cell treatments. FDA mentioned that those who filed INDs for their treatments by the November 2020 deadline for the beginning of enforcement regime will likely get the benefit of the enforcement discretion over those who keep practicing outside the law. FDA expects most of these IND sponsors would have undertaken well-designed investigational studies to evaluate the safety and benefits of their products by the enforcement deadline. Meanwhile, the FDA intends to keep gradually increasing regulatory actions against high-risk stem cell treatment providers. FDA had previously described high-risk stem cell treatment providers as those offering intravenous treatments for a variety of inflammatory diseases such as Crohn’s disease, and neurodegenerative diseases such a MS, Parkinson’s, CTE, and autism. Lower risk providers are those with localized injections such as osteoarthritis. As FDA increases enforcement of its rules for stem cells, it also wants to encourage self-regulation by clinics by either filing INDs for their treatments, forming collaborations with other similar clinics to larger regulatory programs and FDA discussions, or simply closing operations related to stem cell treatments. Apart from the threat of closing stem cell clinics, most of the incentives offered by FDA such as Regenerative Medicine Advanced Therapy (RMAT) designation are hard to get for conventional autologous treatments. So, the best FDA can hope and plans to get is to make stem cell therapies. FDA closed its announcement by re-emphasizing its commitment to support stem cell therapies developed via formal regulatory processes. FDA is fully committed to bring stem cell treatments under the formal regulatory framework, and its seems it will happen soon.