FDA WARNING_LETTER - Celltex Therapeutics Corporation - April 27, 2012

On September 24, 2012, the FDA issued a Warning Letter to CellTex Therapeutics Corporation following an inspection from April 16-27, 2012. The FDA determined CellTex processes autologous adipose tissue to isolate, select, and expand adipose-derived mesenchymal stem cells (AdMSC) for patient administration across various indications, promoting these uses through clinical trials.

The FDA classified CellTex's product as a human cell, tissue, or cellular and tissue-based product (HCT/P) under 21 CFR 1271.3(d). However, the processing, including cell culture and expansion, was deemed to alter the original relevant characteristics of the adipose tissue, failing to meet the "minimal manipulation" definition (21 CFR 1271.3(f)(1)). Additionally, the clinical uses were not considered "homologous use" (21 CFR 1271.3(c)). Consequently, the product does not meet criteria for regulation solely under Section 361 of the PHS Act and 21 CFR Part 1271.

The FDA concluded that CellTex's promotion causes the AdMSC product to be a drug and biological product, requiring a valid biologics license or an Investigational New Drug (IND) application. Since neither was in effect, the product violates the FDC Act and PHS Act.

The inspection also revealed significant