A New Jersey–based company that processes and stores stem cell products derived from human adipose tissue has run aground of FDA regulations.
In a warning letter sent last month, the agency notified the American CryoStem Corporation of Eatontown, New Jersey, that its product, Atcell, doesn’t meet criteria that exempt some human cellular and tissue-based products from the FDA approval process. To bypass approval, structural tissues like human fat must meet “minimal manipulation” criteria: they cannot be processed in a way that changes their original form beyond what could safely be used in reconstruction, repair, or replacement procedures.
Voelker R. Crackdown on Stem Cell Product. JAMA. 2018;319(7):649. doi:10.1001/jama.2018.0486
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