The head of a stem cell company has responded to a warning letter issued by the U.S. Food and Drug Administration that cites several violations at the company that derives stem cells from adipose tissue or body fat.
Dr. Steven Victor of IntelliCell BioSciences said it would be moving to a new facility next month that it believes will address the current good manufacturing practice issues referred to in the warning letter It has also hired consultants with FDA-compliance experience that will help bring its new facilities in compliance with the FDA. Victor added that the company will address all of the FDA’s “observations” on April 3.
The New York company received a warning letter dated March 13 that was published on the FDA’s website yesterday. The letter said that the process that the company uses to produce stem cells from adipose tissue did not meet the FDA’s definition of minimal manipulation for structural tissue such as adipose tissue.
The FDA regulates interstate commerce in human cells and tissue-based products under the Public Health Service Act and the Code of Federal Regulations for Food and Drugs. Although cell-based products that meet this definition need premarket approval to be sold commercially, certain companies are exempt if they conform to provision of the code.
That provision — section 1271.10 of the Code of Federal Regulations for Food and Drugs — requires that the products, in this case, stem cells, are used for the person the cells are taken from, or a first or secondary relative, not combined with anything else other than water, a preservative, or sterilizing or storage products. It also permits these cells to be used for reproduction. Treatments that do not fall within this provision are classified as a drug.
Although there are numerous clinical trials using stem cells to treat cancer and rare diseases, critics say the FDA’s intransigence on stem cell treatments using adult stem cells has produced unintended consequences. Private clinics in the U.S. and outside the country are using adult stem cells for cosmetic surgery and treating other maladies like back pain with no clinical trials to prove their efficacy and safety.
