American CryoStem has received a warning letter from the U.S. Food and Drug Administration (FDA) for marketing its adipose-derived stem cell product Atcell without required regulatory approval, and for “significant deviations” from manufacturing processes that potentially raise safety concerns.
The company has 15 working days to respond to the concerns raised by the agency and detail how they will be corrected, or risk “enforcement actions,” the FDA said in a Jan. 4 press release.
Studies suggest that mesenchymal stem cells can be used to alleviate symptoms and possibly treat several degenerative disorders, including multiple sclerosis.
Atcell is a therapy based on the ability of mesenchymal stem cells isolated from adipose tissue (fatty tissue) to transform into a subset of mature cells, which include adipocytes (adipose cells), osteocytes (bone cells), and chondrocytes (cartilage cells).
Although not approved for use, Atcell is being distributed directly to physicians to treat patients affected by several life-threatening diseases, including Parkinson’s disease, amyotrophic lateral sclerosis, stroke, and multiple sclerosis, the FDA said in its release. It is administered intravenously, intrathecally (injection or infusion into the central nervous system) or by aerosol inhalation.
The product is designed to be used in the same individual (autologous use) the cells are collected from, an approach intended to reduce risk. The cells are extracted using the company’s proprietary Cellect collection system. They are then expanded in the laboratory using the company’s ASCelerate SF-M serum free (animal-product free) media, providing compounds needed for the cells to survive and proliferate. Stem cells put through this process are ready to be used as therapy or to be stored for future use.
A recent FDA inspection found that Atcell’s manufacturing steps are not in line with current good manufacturing practice requirements. Specifically, the manipulation of the adipose tissue was more than “minimal,” the FDA reported, changing “relevant characteristics” of the original tissue that could introduce contamination by microorganisms or product defects and represent a “risk of harm” to patients.
Because of this manipulation, FDA review is required by law to ensure Atcell’s safety and efficacy, the agency said.
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