FDA sends untitled letter to Illinois firm over unapproved stem cell treatments

Regulatory NewsRegulatory News
| 19 April 2022 | By Ferdous Al-Faruque 

The US Food and Drug Administration (FDA) has sent an untitled letter to Illinois-based company The Regenerative Stem Cell Institute over its marketing of stem cell products to treat a slew of conditions without an approved biologics license application (BLA) or an investigational new drug (IND) application filed with the agency.
The untitled letter is the latest in a series of enforcement actions FDA has taken to rein in clinics offering unproven treatments in the wake of the agency’s enforcement discretion policy for such products. The Center for Biologics Research and Evaluation (CBER) sent more than a dozen similar untitled letters to firms in 2020 and 2021. (RELATED: Time's up for questionable cell and tissue products, says Marks, Regulatory Focus 22 April 2022)
In an untitled letter dated 6 April to the company’s president John Prunskis, the FDA said the company seemed to be improperly trying to use an Institutional Review Board (IRB) Approved Research Protocol as a means of getting around submitting an IND.
“You claim that your cellular products are offered ‘under an IRB Approved Research Protocol,’” the FDA said. “Before initiating clinical trials with an investigational drug or biological product, a sponsor must have both an IND in effect and an approval from an Institutional Review Board (IRB). 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 said the company made promotional claims about its stem cell therapy products on its website, Facebook page and YouTube channel, including claims that the products benefited patients with chronic obstructive pulmonary disease (COPD) and can treat other conditions such as cerebral palsy, asthma and rheumatoid arthritis.
“Based on the review of the materials described [in the letter], it appears that your firm does not qualify for any exception in [regulations], and that the above-referenced products are intended for non-homologous uses,” the FDA said. “Accordingly, it appears that the products would be regulated as drugs …and biological products as defined in [regulations.]”
The Regenerative Stem Cell Institute has 30 days from receiving the untitled letter from the FDA to respond to the agency’s concerns and how it plans to comply with regulations.
“If you do not believe there is a basis for the regulatory issues raised in this letter, include your reasoning and any supporting information for our consideration,” FDA said.


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