FDA Presents a Glimpse of Upcoming Stem Cell Regulation with a New WL 
[Thursday, September 5, 2019]

Over the weekend, FDA issued a Warning Letter to Stemell, Inc., a manufacturer of umbilical cord blood stem cells for allogeneic use. The letter contains an element not seen in previous warning letters to stem cell companies that point towards FDA’s strategy for the upcoming enforcement actions on these companies. In the Warning Letter, FDA made an absolute unequivocal rejection of the legal disclaimers on the company’s website and marketing material. On its website, Stemell included explicit disclaimers about its products not being intended to treat, cure or prevent disease, and that its products are not approved by the FDA. The website also claims that Stemell only “supplies” cord blood stem cells to physicians and clinics and not to patients. In its Terms and Conditions of Sale, Stemell prohibited its customers from using the product to cure or treat any disorder and claimed indemnity from any such uses. However, FDA rejected all these legal disclaimers and accused the company of creating a facade with such statements while knowing that its customers intended to use the cord stem cells for exactly the same purposes as disclaimed. FDA claimed in the warning letter that despite the written legal disclaimers, Stemell is a manufacturer of a cellular therapy product subject to IND and BLA requirements. Thereafter the warning letter goes on to list various deficiencies of Good Tissue Practices and Good Manufacturing Practices. Apparently Stemell had been working to address FDA’s comments for the last 6 months and had made several corrections to its GMP conditions but FDA seemed to clearly have an agenda to force Stemell to file an IND application prior to continuing to supply its product to its customers. The Warning Letter should act as a notice to all other similar “suppliers” that no matter how much legal coverage they create by disclaimers and marketing practices, FDA intends to hold them responsible for the actions of their customers. It may seem unfair for FDA but most of such stem cell suppliers have been in business with the explicit understanding that physicians will use the products for treatments despite the disclaimers. Seems like FDA is planning to call their bluff.