Stem Cell Company Receives Raft of Warnings From FDA

Stem Cell Company Receives Raft of Warnings From FDA

March 28th, 2012 // 12:44 pm @

Source: Pharmalot

From its offices on the east side of Manhattan, IntelliCell BioSciences makes what ceo Steve Victor likes to call a soup – physicians remove fat from their patients and send this to IntelliCell, which has the fat removed and returns the remaining cells to the doctors, who can administer these to their patients to treat various ailments on an off-label basis, according to the video.

To be specific, doctors can administer the cells intravenously into someone’s lips, cheeks, knees, scalp or butt for treating wrinkles, osteoarthritis, and gum recessions, and for breast augmentation. However, the FDA believes IntelliCell has violated various federal regulations. One involves its process for adipose tissue, which is another way of saying body fat.

“Specifically, your processing alters the relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement. Therefore the processing would not meet the definition of minimal manipulation for structural tissue such as adipose tissue,” the FDA writes in a March 13 warning letter, explaining IntelliCell has run afoul of federal regulations.

The agency then says some of the treatments offered do not meet the definition of homologous use, which means the repair, reconstruction, replacement or supplementation of a recipient’s cells or tissues with a biological that performs the same basic function in the recipient as in the donor. As a result, says the FDA, its product is a drug and a biologic.

But IntelliCell does not have an approved biologics license application for its products or an investigational new drug application. Consequently, the product violates both the Food, Drug & Cosmetic Act, as well as the Public Health Service Act. In other words, two for the price of one. We left a message with Victor for a reply and will update you accordingly.

Meanwhile, there is more. The FDA inspected the IntelliCell premises between August 2010 and November 2011, and found a laundry list of problems with good manufacturing practices. These included a “failure to have written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, and a failure to ensure appropriate lab testing of each batch of drug product required to be free of objectionable microorganisms,” according to the letter.

There was also a failure to reject drug products that did not meet “established standards or specifications and any other relevant quality control criteria, and a failure to establish and follow written production and process control procedures designed to assure that drug products have the identity, strength, quality, and purity they purport or are represented to possess,” the letter states.

Here are a few more: “a failure to establish a written record of major equipment cleaning, maintenance, and use, and to include in that record the date, time, product and lot number of each batch processed; a failure to establish and maintain procedures to control the labeling of (human cells, tissues, and cellular or tissue-based products.”

There was also “a failure to establish and follow written procedures for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product.” And the processing area ceiling had missing tiles exposing the building’s ventilation system. Time to call the landlord, yes?

And this encompasses a great deal of issues: “a failure to maintain lab controls that included the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity, including a determination of conformance to written descriptions of sampling procedures and appropriate specifications for acceptance of each lot of drug products.”


Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner