On Mar. 13, 2012, FDA issued a Warning Letter to Steven Victor, CEO of IntelliCell Biosciences for a violation of the Food, Drug, and Cosmetic Act (FD&C Act), and for violations of cGMP and Good Tissue Practice (GTP) in the manufacture of its adipose tissue-derived stem-cell product.

IntelliCell’s product is derived from aspirated adipose tissue that is processed to produce a fraction containing adipose-derived stem cells. The cellular product is then readministered to the donor patient as an autologous therapy. Uses that the company promotes for the product include treatment of wrinkles and osteoarthritis, and for breast augmentation.

Human cells, tissues, or cellular and tissue-based products are not considered to be biological drug products provided they meet the criteria listed in 21 CFR 1271.10. Those requirements stipulate that the product be minimally manipulated and intended only for homologous use.

However, according to the FDA Warning Letter, Intellicell’s cellular product did not meet all of the criteria in 21 CFR 1271.10 because processing altered the relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement. FDA also found that the treatments for which the cellular product was recommended did not meet the requirements for homologous use. FDA, therefore, found the product to be a drug under 201(g) the FD&C Act and a biological product as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)]. Because the product lacked either an investigational new drug application or a biological license application, FDA found it to be in violation of the FD&C Act.

The Warning Letter also listed 16 violations of cGMP and GTP that were identified after a November 2011 inspection. The violations included deficiencies in sterility control and assurance, insufficient product characterization and quality control, lack of written records for equipment cleaning and maintenance, and inadequate labeling. The company had requested extensions for replying to the inspection report on Jan. 30, 2012, and Mar. 9, 2012. The Warning Letter indicated that the minimal responses received so far were inadequate and requested a response within 15 days to inform the agency of any additional steps that have been taken or will be taken to correct the noted violations and to prevent their recurrence, along with documentation necessary to show that correction has been achieved.