FDA warns another unapproved cell therapy firm
The FDA sent a warning letter to Stemell. “You specifically market your products to “combat inflammatory conditions such as arthritis” and more generally to “expedite the healing process” and as an alternative to surgery.
Indeed, the FDA encountered deviations cGMP and cGTP while investigating this company in March 2019. In addition, their findings included errors in cell and tissue donor documents, insufficient procedures to prevent microbial contamination, as well as insufficient written procedures for production and process control.
Moreover, the agency is pursuing groups with unapproved stem cell therapies and the clinics that make and market them. What is more, the former commissioner Scott Gottlieb, the Agency provided guidance for regenerative medicine to encourage innovation and availability to transformative therapies. Within this scope is the swift action against unscrupulous actors who do not have the patient’s best interest at heart.
“This company failed to take appropriate measures to protect patient safety. The FDA will be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.
“Those who are manufacturing or marketing unapproved, potentially unsafe products must understand that there’s a clear line between appropriate development of these products and those practices that sidestep important statutory and regulatory controls that are in place to protect patients.”