Illinois Company Receives Untitled Letter for Marketing Unapproved HCT/Ps

April 19, 2022

The Food and Drug Administration recently sent an untitled letter to the owner of The Regenerative Stem Cell Institute, an Illinois company, regarding the marketing of unlicensed cellular products for which the company does not have an FDA-approved biologics license application (BLA) or investigational new drug (IND) application.

According to FDA, the company markets cellular products derived from adipose tissue as “regenerative medicine therapy,” “adipose stromal vascular fraction (SVF) therapy,” and “therapy” to treat various diseases or conditions, including cerebral palsy, asthma, emphysema and chronic obstructive pulmonary disease.

Based on a review of the company’s social media advertisements, FDA stated that the company’s cellular products appear to be human cells, tissues, or cellular or tissue-based products (HCT/Ps) that should be regulated as both drugs and biological products. To lawfully administer and market these products, a firm must have a valid BLA, which is issued only after the company demonstrates the product is safe, pure and potent for the intended treatment of patients. While the investigational product is under development, the firm must have an FDA-approved IND, as specified by FDA regulations.

Additionally, the company claimed that it offers products “under an Institutional Review Board (IRB)-Approved Research Protocol.” However, FDA noted that IRB approval is required in addition to, not in lieu of, obtaining an effective IND from FDA for the study of the investigational drug or biological product.

FDA directed the company to its comprehensive regenerative medicine policy framework for HCT/Ps and requested a written response within 30 days of receipt of the letter.