CBER Raises Concerns With Cell Product Promoter RejuvaYou
Regulatory News | 14 February 2020 |
The US FDA’s Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research (CBER) earlier this week raised alarms with South Pasadena, CA-based RejuvaYou Medical Corporation, which claims to treat people with serious illnesses with umbilical cord blood and other cellular products.
RejuvaYou markets the products to treat various diseases or conditions, including some that are serious or life-threatening, FDA’s untitled letter notes, and the firm administers them intravenously or intranasally. But the company is marketing the treatments without first winning FDA approval.
Because the products are intended for nonhomologous uses, FDA adds, the company does not qualify for any exception in 21 CFR 1271.15 and has to submit applications for approval. The agency also points out how the firm markets its treatments for cerebral palsy, traumatic brain injuries, end-stage lung disease and brain atrophy to consumers, including to parents of children with some of these conditions.
The company’s Facebook page, which the untitled letter says CBER reviewed, features patient testimonial videos, including one from a woman from Portugal who traveled for treatment with her daughter who has cerebral palsy.
CBER said: “Such unapproved uses raise potential significant safety concerns. Moreover, because the products are administered by various higher risk routes of administration, their use, if contaminated could cause a range of adverse events.”
Last July, the company’s CEO promoted the products in the South Pasadena Review, explaining: “I’ve used stem cell therapy to treat all sorts of patients, from children with cerebral palsy to adults with Parkinson’s disease. I helped a female firefighter reverse a bad case of Chronic Obstructive Pulmonary Disease, which was caused by smoke burning her lungs. I successfully treated a young boy who suffered seizures and brain damage from nearly drowning in a swimming pool. I have children fly in from around the world to seek treatment for their cerebral palsy and all of them experience significant improvement in their conditions.”
The untitled letter also said that it appears that the company treats patients with exosomes, which were part of a separate public safety alert from FDA last December, but which are being studied in more than 100 clinical trials, according to ClinicalTrials.gov.
“As a general matter, exosomes for clinical use in humans are also regulated as drugs and biological products under section 351 of the PHS Act and the FD&C Act and are subject to premarket review and approval requirements,” CBER said.
But CBER’s issuance of an untitled letter, rather than a warning letter, means that the letter does not include a statement saying that RejuvaYou’s failure to promptly correct the violations may result in enforcement action.
Untitled Letter
RejuvaYou markets the products to treat various diseases or conditions, including some that are serious or life-threatening, FDA’s untitled letter notes, and the firm administers them intravenously or intranasally. But the company is marketing the treatments without first winning FDA approval.
Because the products are intended for nonhomologous uses, FDA adds, the company does not qualify for any exception in 21 CFR 1271.15 and has to submit applications for approval. The agency also points out how the firm markets its treatments for cerebral palsy, traumatic brain injuries, end-stage lung disease and brain atrophy to consumers, including to parents of children with some of these conditions.
The company’s Facebook page, which the untitled letter says CBER reviewed, features patient testimonial videos, including one from a woman from Portugal who traveled for treatment with her daughter who has cerebral palsy.
CBER said: “Such unapproved uses raise potential significant safety concerns. Moreover, because the products are administered by various higher risk routes of administration, their use, if contaminated could cause a range of adverse events.”
Last July, the company’s CEO promoted the products in the South Pasadena Review, explaining: “I’ve used stem cell therapy to treat all sorts of patients, from children with cerebral palsy to adults with Parkinson’s disease. I helped a female firefighter reverse a bad case of Chronic Obstructive Pulmonary Disease, which was caused by smoke burning her lungs. I successfully treated a young boy who suffered seizures and brain damage from nearly drowning in a swimming pool. I have children fly in from around the world to seek treatment for their cerebral palsy and all of them experience significant improvement in their conditions.”
The untitled letter also said that it appears that the company treats patients with exosomes, which were part of a separate public safety alert from FDA last December, but which are being studied in more than 100 clinical trials, according to ClinicalTrials.gov.
“As a general matter, exosomes for clinical use in humans are also regulated as drugs and biological products under section 351 of the PHS Act and the FD&C Act and are subject to premarket review and approval requirements,” CBER said.
But CBER’s issuance of an untitled letter, rather than a warning letter, means that the letter does not include a statement saying that RejuvaYou’s failure to promptly correct the violations may result in enforcement action.
Untitled Letter
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