A warning letter issued by the U.S. Food and Drug Administration has cited numerous violations by a stem cell company and claimed it did not have an appropriate license to produce stem cells.
IntelliCell BioSciences in New York derives stem cells from adipose tissue, or fat cells, for treatments ranging from lower back pain to cosmetic surgery. The company claims the cells can be administered to patients intravenously or injected into specific areas of the body, such as the lips, cheeks, knees, scalp, and/or buttocks, the letter said.
It sought to license the technology to institutions that are seeking to use stem cells in their research.
According to the letter, the way the company processes adipose tissue to generate stem cells “alters the relevant characteristics of the adipose tissue” for “reconstruction, repair, or replacement.” By processing the tissue, the FDA letter said, the company does not meet the requirements of minimal manipulation for structural tissue.
The FDA permits autologous stem cell transplantation in which blood-forming stem cells are removed, stored and later given back to the same person. But the regulator said in the letter that treatments such as osteoarthritis and gum recession did not meet the terms of autologous use.
The letter also highlighted additional violations it found after an inspection at the end of last year that included violations of good tissue practice and good manufacturing practices. It also took issue with the company’s reference to off-label uses for its treatment in its YouTube video that promotes the company.
The company’s laboratory came under criticism, with the letter cataloging problems such as failing to ensure appropriate laboratory testing of each batch of drug product required to be free of objectionable microorganisms and failing to reject drug products that did not meet established standards or specifications and any other relevant quality-control criteria.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In order to lawfully market the kind of treatment IntelliCell produces, referred to by the FDA as a biological drug product, the company needs a valid biologics license. To obtain the license, companies need to show safety and efficacy for the product’s intended use, according to a statement from the FDA. Otherwise, the company has to have an investigational new drug application in effect.
On its website the company said it is planning to conduct clinical trials in osteoarthritis, sports medicine injuries, gingival gum regeneration and dermal treatment for burns and nonhealing wounds.
“The IntelliCell product is not the subject of an approved biologics license application, nor is there an IND in effect. Based on this information, we have determined that your product violates the FD&C Act and the PHS Act,” the letter said.
The FDA requires biological activities for stem cells to be evaluated individually under the provisions governing human cells, tissues and cellular and tissue-based products, an emailed statement from the FDA said. For stem cell therapies that do not meet the criteria mapped out by the provision, companies need to obtain a biologics license application before commercial marketing.
The company was given 15 days to respond to the letter or face regulatory action.
