The US Food and Drug Adminstration (FDA) has posted a warning letter to American CryoStem Corporation and its chairman/chief executive officer, John S. Arnone, for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that raise potential significant safety concerns, putting patients at risk.
Warning
The warning letter was posted after a recent inspection of the company during which the FDA found that it was receiving and processing adipose tissue into a product called Atcell and then marketing such product without the required approval. Though the product is intended for autologous use (use in the same individual from which it was recovered) the manner in which it is being processed involves more than minimal manipulation of the adipose tissue, which may lead to contamination of the product and thus risk to patients. As a result, under existing law, the product is required to undergo FDA review to ensure the treatment is safe and effective.
“As part of our comprehensive policy framework for the efficient development and regulation of cell-based regenerative medicine, we’re going to be stepping up enforcement activities against those who manufacture and market products in ways that put patients at risk,” said FDA commissioner Dr Scott Gottlieb. “We see great promise from the field of cell based regenerative medicine, but there are also novel risks. Our goal is to implement our new policy framework in a way that helps this promising field advance, while making sure that we address issues that can put patients at risk. It also means taking an efficient, risk-based approach to making sure that products undergoing more than minimal manipulation, which makes them subject to FDA’s review and approval, and particularly products intended to treat serious and/or life-threatening disease or conditions, must prove that they deliver the benefits they’re promising to patients.”
Furthermore, the FDA highlighted potential risks with the way that the product is administered to patients and how it is promoted for the treatment of serious or life-threatening diseases or conditions.
“The use of Atcell raises potential significant safety concerns, due in part to the fact that there is little basis on which to predict how the product will perform in a patient,” added Dr Peter Marks, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “In addition, this product may also cause harm to patients who may put their trust in an unproven therapy and make the decision to delay or discontinue medical treatments proven to be safe and effective.”
After the inspection the FDA issued a list of inspectional observations to American CryoStem and although the company responded, the FDA found the responses to be unsatisfactory. American CryoStem has 15 working days to respond to the FDA highlighting how it will correct the specified violations.