FDA WARNING_LETTER - American CryoStem Corporation - July 26, 2017

On January 3, 2018, the FDA issued a Warning Letter to American CryoStem Corporation following a July 17-26, 2017, inspection. The firm processes adipose tissue into Stromal Vascular Fraction (SVF) and then expands it through cell culture to produce ATCELL?, an autologous product shipped to physicians for various conditions including anoxic brain injury, Parkinson's, ALS, stroke, and multiple sclerosis.

The FDA determined ATCELL? is a human cell, tissue, or cellular or tissue-based product (HCT/P) but fails to meet the minimal manipulation (21 CFR 1271.10(a)(1)) and homologous use (21 CFR 1271.10(a)(2)) criteria. Processing adipose tissue into SVF and subsequent cell expansion are considered more than minimal manipulation, altering original characteristics. The intended uses for various diseases are not homologous to adipose tissue's basic functions. Therefore, ATCELL? is regulated as a drug and biological product, requiring an approved biologics license application (BLA) or an investigational new drug (IND) application, neither of which is in effect.

The inspection also revealed significant deviations from current Good Manufacturing Practice (CGMP) under 21 CFR Parts 210 and 211, posing safety concerns due to potential contamination and quality defects. Deficiencies include: 1.