In a September 24th letter to Celltex the US Food and Drug Administration (FDA) took the position that a person’s own, identical mesenchymal stem cells are “biological drugs” when that person receives them in a medical treatment. Drugs (including biological drugs) require extensive pre-market testing and documentation submissions to the agency before commercial distribution. While the letter is considered an advisory opinion, it is a statement of the agency’s position. On October 16th Celltex sent FDA its response. In summary, Celltex stated:
“While Celltex respectfully disagrees with the positions outlined in the September 24 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 to treat the Mesenchymal Stem Cell (MSC) product as a biological drug and develop Investigational New Drug (IND) submissions for clinical trials.
As the September 24 letter is an advisory opinion, not final agency action on the issues it raises, 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 September 24 letter. Upon completion of a thorough examination of all relevant information, Celltex believes FDA will determine that Celltex’s stem cell technology can operate in compliance as an HCT/P-only product.”
Celltex’s letter to the FDA can be found here.
As we work with the FDA, Celltex will continue to make advances on the frontier of regenerative medicine. Thus, Celltex is now proceeding with all of the appropriate steps to develop the necessary pre-market testing, including clinical trials for specific disease and conditions. Please contact us if you have any questions about this process.