CBER’s first untitled letter of 2023 dings clinic over unlicensed stem cell products

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) last week sent an untitled letter to Los Angeles-based Thomas Advanced Medical LLC stating that the firm’s stem cell products, which it markets for various diseases including Alzheimer’s disease and COVID-19, require regulatory approval under the agency’s regenerative medicine framework.
 
The untitled letter is the first sent by CBER’s bioresearch monitoring program (BIMO) in 2023 after a lull in enforcement letters in 2022 that followed a flurry of activity in 2020 and 2021 as the agency prepared to wind down its enforcement discretion policy toward certain unlicensed regenerative medicines. (RELATED: Time's up for questionable cell and tissue products, says Marks, Regulatory Focus 22 April 2021)
 
In the latest letter, FDA said the materials it reviewed, which include the firm’s website and LinkedIn page, indicate that it markets products derived from either human umbilical cord, umbilical cord blood and amniotic tissue as “regenerative therapy solutions” and “stem cell derived biological products” to consumers.
 
“You and your firm market your products to treat various diseases or conditions, including some that are serious or life-threatening, such as cardiac diseases, Alzheimer’s disease, Parkinson’s disease, lung diseases, and diabetes. According to materials FDA reviewed, your products are intended for intravenous, intrathecal, intra-articular, subcutaneous, or intramuscular injection or topical use,” the letter states.
 
The agency also noted that the clinic offered its umbilical cord derived product PrimePro to treat COVID-19.
 
“Your above-referenced products appear to be human cells, tissues, or cellular or tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d) that would be subject to regulation under 21 CFR Part 1271, issued under the authority of section 361 of the Public Health Service Act (PHS Act),” FDA said, noting that the products do not meet the criteria for exception under 21 CFR 1271, meaning that they are regulated as drugs, medical devices or biological products.
 
The untitled letter adds that the company does not have an approved biologics license application (BLA) or investigational new drug application (IND) in effect for any of its products.
 
“You and your firm are responsible for ensuring that all your products fully comply with the [Federal Food, Drug, and Cosmetic Act] FD&C Act and PHS Act and all applicable regulations. We request a written response within 30 days of your receipt of this letter,” FDA wrote.
 
Untitled letter