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FDA Warns Company Marketing Unapproved Stem Cell Product

January 5, 2018

The Food and Drug Administration (FDA) has sent a warning letter to American CryoStem Corporation (Monmouth Junction, New Jersey) for marketing Atcell, an adipose derived stem cell product, without the agency’s approval. The letter also warns of significant deviations from current good manufacturing practice requirements, including some that may put patients at serious risk.

The American CryoStem Corporation receives and processes adipose tissue to produce Atcell for autologous use, and then ships the product back to the treating physician. Atcell is used to treat a range of conditions and diseases, including anoxic brain injury, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), stroke, and multiple sclerosis (MS). It is administered either intravenously, intrathecally or by aerosol inhalation.

The FDA has warned that a valid biologics license must be in effect to lawfully market Atcell. While in the development stage, an investigational new drug application must be in effect to lawfully distribute Atcell for clinical use.

An FDA inspection of American CryoStem has revealed evidence of significant deviations from current good manufacturing practice requirements in the manufacture of Atcell, including “unvalidated processes, an inadequately controlled environment, lack of control of components used in production, and a lack of sufficient and validated product testing.”

American CryoStem must respond to the FDA warning letter within 15 working days.

 

Food and Drug Administration (FDA).
FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell [news release]. January 4, 2018. Available at: click here. Accessed January 4, 2018.