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the maker of an allogenic, adipose-derived stromal vascular fraction (SVF) product that its product is a drug and a biologic and must be regulated as such.

The agency also told Maryland-based Akan Biosciences that its allogenic SVF product Ayama was in violation of a number of current good manufacturing practice (CGMP) requirements -- including failing to screen donors for communicable diseases.

A novel aspect of this product is that adipose-derived SVF is usually autologous, not allogenic, said Paul Knoepfler, PhD, a stem cell biologist at the University of California Davis who blogs about stem cells.

"Allogeneic SVF hasn't really been much of a thing," Knoepfler said in an email to 乌鸦传媒. "It is nearly 100% autologous as sold by stem cell clinics, so this is a unique case and kind of interesting."

Knoepfler that SVF is "one of the most contentious areas of regenerative medicine."

"While the allogeneic SVF focus makes this unusual, on the other hand, the warning to Akan Biosciences is typical for such letters in that it notes that the product being marketed is an unapproved drug and highlights several CGMP-type problems," Knoepfler wrote.

So, why focus on this firm? "Maybe in this case it was the unusual allogenic SVF product that sparked attention?" he wrote.

In the warning letter to company president Mukesh Kumar, PhD, the FDA said Ayama should be regulated as a biological product under section "351" of the Public Health Service Act, rather than the more lax "361" human cell, tissue, or cellular or tissue-based product (HCT/P) pathway.

FDA noted Ayama fails to meet two important criteria to be classified under the 361 pathway. It doesn't meet "minimal manipulation" criteria because processing "alters the original relevant characteristics of the adipose tissue related to its utility for reconstruction, repair or replacement," the agency wrote.

Nor does it meet homologous use criteria, as it is "not intended to perform the same basic function or functions of adipose tissue in the recipient as in the donor, such as cushioning and support for other tissues, including the skin and internal organs, storing energy in the form of lipids, and insulating the body, among other functions," FDA wrote.

Violations of CGMP raised by FDA in the letter include failing to screen donors for communicable diseases including HIV and hepatitis C and B, and using a donor screening form that doesn't address certain risk factors for relevant communicable diseases.

The violations were discovered during an inspection in September 2022 and involved nearly 600 vials of the product made between May 2021 and April 2022, the agency said. In response, Akan Biosciences initiated a voluntary recall of Ayama at the end of September 2022. Nonetheless, FDA said the company's response has been inadequate.

As of press time, Akan Biosciences has not responded to a 乌鸦传媒 request for comment on the FDA's claims or whether it had responded to the FDA's letter.

FDA continues to crack down on unapproved regenerative medicine therapies, which the agency has been trying to bring into . That list includes various birth tissue products -- such as amniotic fluid, umbilical cord blood, cord blood stem cells, and Wharton's jelly -- as well as other stem cell products, SVF, orthobiologics, and exosomes.

The agency now requires manufacturers of such products to meet premarket approval criteria, or conduct research under its investigational new drug (IND) requirements.

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