FDA WARNING_LETTER - Mother Stem Institute, Corp. - September 03, 2024

On August 20, 2024, the FDA issued a Warning Letter to Dr. Skupin of Mother Stem Institute after reviewing their website (www.mothersteminstitute.com) and a February 16, 2024, records request response. The firm processes adipose tissue into stromal vascular fraction (SVF) using enzymatic digestion, administering it intravenously for conditions like Alzheimer’s, Type I/II Diabetes, Lupus, and Rheumatoid Arthritis.

The FDA determined the SVF product is an unapproved new drug and biological product under the FD&C Act and PHS Act, respectively, because its intended uses establish it for disease treatment and affecting body structure/function. It is also an HCT/P, but fails to meet the criteria in 21 CFR 1271.10(a) and does not qualify for exceptions like 21 CFR 1271.15(b) (same surgical procedure) because the processed SVF is not the "same HCT/P" as the original adipose tissue. Furthermore, the enzymatic digestion constitutes more than "minimal manipulation" (21 CFR 1271.10(a)(1) and 1271.3(f)(1)) as it alters the adipose tissue's original relevant characteristics for cushioning and support.

The SVF product lacks an approved biologics license application (BLA) or an