The US Food and Drug Administration (FDA) late last month sent an untitled letter, its third of the year, to California-based Chara Biologics for marketing an unapproved stem cell product as a possible treatment for autism and other conditions with few treatment options.

FDA says the product appears to be a human cell, tissue, or cellular or tissue-based product (HCT/P) and the company’s website notes a few stories that suggest the stem cell treatment may help children with autism or people who suffer from traumatic brain injuries, cardiac issues, COPD, osteoarthritis, dementia and autoimmune disorders like lupus or psoriasis.

“Such unapproved uses raise potential significant safety concerns. Additionally, because the product is administered by various higher risk routes of administration, including IV, its use, if contaminated could cause a range of adverse events,” the letter says.

FDA also notes that based on a review of the company’s websites, “it appears that Chara Biologics, Inc. does not qualify for any exception in 21 CFR 1271.15, and that CharaCore™ is intended for nonhomologous uses.”
The letter also directs the company to FDA’s Framework for the Regulation of Regenerative Medicine Products.

Two weeks ago, FDA also sent an untitled letter to Florida-based manufacturer RichSource Stem Cells over unsubstantiated claims for its Richgen allograft product. And last May, FDA sent another untitled letter to Arizona-based R3 Stem Cell and its more than 50 affiliate centers or clinics.

FDA is approaching the end of its 36-month period of enforcement discretion that began in November 2017, during which the agency said it would focus its efforts on products that raise the greatest safety concerns.

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