Celltex Therapeutics Corp., the Houston company that took stem cells from Texas Governor Rick Perry, cultured them and returned them to treat his lower back pain, has agreed to abide by an FDA request to treat the mesenchymal stem cell (MSC) product as a biological drug and develop Investigational New Drug (IND) submissions for clinical trials.
Perry told OTW that he disagreed with the FDA request at the Houston Stem Cell Summit on October 26. The FDA letter came a few months after the Texas Medical Board implementing a policy allowing physicians to use banked stem cells.
Perry said that therapies involving one’s own stem cells should not be regulated by the FDA any more than bone marrow transplants or in vitro fertilization.
Celltex sent the FDA a response requesting a meeting to try and convince the agency to change its mind. “While Celltex respectfully disagrees with the positions outlined in the September 24 [FDA] letter, Celltex believes that this technology’s therapeutic potential can be brought to fruition as a biological drug as the agency states. Although the regulatory requirements for a biological drug are excessive for an autologous mesenchymal stem cell therapy such as Celltex’s, Celltex will follow the agency’s request.”
The FDA letter is an advisory opinion, not final agency action. Celltex’s response letter serves to explain why its product is not in violation of the FDCA and the PHS Act. Celltex has also requested an in-person meeting with FDA for an in-depth discussion of critical points raised for the first time in the FDA letter. “Upon completion of a thorough examination of all relevant information, Celltex believes the FDA will determine that Celltex’s stem cell technology can operate in compliance as an HCT/P-only product, ” stated the letter.
