Two more stem cell firms slapped with untitled letters

Regulatory NewsRegulatory News | 10 August 2021 |  By 

Untitled letters issued to two firms for marketing unapproved stem cell products signal that some in the industry are undeterred by the US Food and Drug Administration’s (FDA) efforts to get these products approved or off the market.    
The letters join four others from the Center for Biologics Evaluation and Research (CBER) in recent months to clinics marketing unapproved stem cell products after an enforcement grace period ended on 1 June. (RELATED: CBER targets four stem cell firms with untitled letters, Regulatory Focus, 20 July 2021)
Companies selling these products after this date may face tough enforcement action, including potential injunctions, civil monetary penalties, and seizures (RELATED: Time’s up for questionable cell and tissue products, says Marks, Regulatory Focus, 22 April 2021)
The 5 August untitled letter to Stem Cell Therapy of Las Vegas objected to the company’s marketing of unlicensed cell therapy products on its website, as well as its claims that these products can treat diseases and conditions such as congestive cardiac failure, Alzheimer’s disease, multiple sclerosis, autism, chronic obstructive pulmonary disease, Crohn’s disease, lupus and macular degeneration.
The agency also objected to claims on the company’s website that the “revolutionary” stem cell therapies could help resolve autoimmune conditions and took issue with testimonials on the firm’s Facebook page stating that the stem cell therapy treatment successfully worked in helping a paralyzed patient walk again, and that another treatment resulted in a patient’s no longer needing a catheter to treat a bladder problem.
According to FDA, the company’s products do not meet the exception criteria for human cell, tissue or cellular or tissue-based products (HCT/Ps) laid out in 21 CFR 1271.10(a) and the criteria under 21 CFR 1271.15 under section 361 of the Public Health Service Act.
“Such products are regulated as drugs, devices, and/or biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and/or the PHS Act, and are subject to additional regulation, including appropriate premarket review.”
FDA referred the company to the agency’s comprehensive regenerative medicine policy framework for HCT/Ps issued in 2017 and requested a written response within 30 days of the letter’s receipt.
Another untitled letter
FDA told another company, The Regen Centers in Rancho Mirage, CA, that its stem cell treatments do not meet the exceptions for an HCT/P and that approved BLAs are required to keep the products on the market.
The 8 July untitled letter said the company was marketing cellular products derived from human umbilical cord and umbilical cord tissue to treat various disease such as chronic obstructive pulmonary disease, leukemia, diabetes, heart failure, and other diseases without approved biologics licenses.
FDA is “concerned” about the slow uptake from companies seeking regulatory approval to market and distribute cell therapies and is therefore stepping up their enforcement effort against companies making unapproved therapies, Wilson Bryan, director of the Office of Tissues and Advanced Therapies at CBER, said at a recent industry meeting  (RELATED: FDA disappointed with slow uptake of approvals for stem cell therapies, Regulatory Focus, 9 June 2021)
Untitled letter to Stem Cell Therapy; Untitled letter to The Regen Centers


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