Mother Stem Institute, Corp.

Warning LetterOpen

Alvaro Skupin, M.D. Founder Mother Stem Institute, Corp. 2100 Ponce De Leon #1080 Coral Gables , FL 33134 United StatesIssued Aug 20, 2024Center for Biologics Evaluation and Research (CBER)

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations5

Issue DateAug 20, 2024

Product TypeBiologics

StatusOpen

Letter Details

Firm: Mother Stem Institute, Corp.
Location: Alvaro Skupin, M.D. Founder Mother Stem Institute, Corp. 2100 Ponce De Leon #1080 Coral Gables , FL 33134 United States
FEI Number: N/A
Country: United States
Issue Date: August 20, 2024
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Biologics
Status: Open

Summary

Mother Stem Institute, Corp. was warned for manufacturing and marketing stromal vascular fraction (SVF) derived from adipose tissue as an unapproved biologic drug product without proper FDA authorization or compliance with human cells, tissues, and cellular products (HCT/P) regulations. The company's website made unsubstantiated therapeutic claims for treating serious diseases including Alzheimer's disease, marketing the product as capable of transforming into lost cell types and providing preventative and therapeutic effects. The FDA identified these violations following a website review and the company's response to a records request regarding their enzymatic digestion processing method and intravenous administration of the SVF product.

Mother Stem Institute, Corp. FDA Warning Letter, August 20, 2024