Tuesday, November 20, 2007

Epicel is FDA approved

PR Newswire
October 29th, 2007

The FDA has granted Genzyme Corporation marketing approval for its product Epicel, which stands for cultured epidermal autograph. The rights were granted under the Humanitarian Device Exemption (HDE) for use in life threatening wounds due to severe burns. With its approval Epicel became the first xenotransplantation-classified product to be approved in the U.S. It is considered xenotranslplantation it includes animal cells.

The skin is taken from the patient and then grown on a layer of mouse cells, which expedite the growing process. The skin is grown in lengths which can then be used as grafts. The process takes 16 days to complete and then takes 3 to 4 weeks to incorporate after being attached. Epicel is meant for patients who have suffered damage to more than 30 percent of the body since they no longer have enough healthy skin to cover their burns, though it can also be used with split-thickness autografts. Dr. Rajiv Sood, medical director at Indiana University School of Medicine said that Epicel “has been the most important advance in burn care for the coverage of large total body surface area burn wounds in this decade”.

The press release from PR Newswire released October 29th, 2007 was very thorough in portraying Epicel in its entirety. It mentioned the antibiotics with which it was cultured and that traces of these antibiotics may still be on the graft. It also pointed out that the cells were grown in a medium of cells that have bovine and murine origin.

It also highlighted the danger of the grafts being xenotransplantation-classified. Since the cells were grown in the same culture as mouse cells, there is always the chance of contamination, even though the cells have been tested for bacteria, fungi and viruses. The press release also points out that since the effect of xenotransplantation is not yet known the patients who receive the graft should not donate blood or blood parts, tissue, breast milk, egg, sperm, or other body parts to be used in humans.

Epicel's approval is a big step. Though xenotransplantation is strictly regulated, at the moment there is no technology better than the Epicel cells. The FDA has been very strict about xenotransplantation and the only reason Epicel was approved is because there is not a better option. The HDE makes it possible for new procedures and technologies to be able to be distributed, but Genzyme should work to get general approval. If Epicel can get approval for widespread use then it would be a good option for all burn victims, and may even take over for cadaver donation.

Though the press release emphasized that the inclusion of mouse cells was a risk and that the recipients should not donate any part of their body, it left out a major component of transmission, child birth. With the inclusion of another species in the growing of the grafts there is always the chance that they will transmit a virus or pathogen that is not yet known in humans. If the patient then gets the virus they need to contain it to themselves and so they should not reproduce, in addition to bodily donation.

Yet if Epicel can be used effectively and prove that the xenotransplantation has no negative effects than it can be a very great resource for skin grafts. The harvested skin is the size of a postal stamp and can then be grown to cover the entire body. It would allow for there to be enough grafts available for all patients who need them.

Also the animal rights controversy that usually surrounds xenotransplantation doesn't really affect Epicel. Animal activists though in their plea that all animals are equal, don't really seem to care about mice. If the human cells were grown on animal cells other than mice, then there might be an issue, but as it stands right now there isn't.


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