Ortec International Inc. has begun clinical trials of its CompositeCultured Skin (CCS) to treat full and deep partial-thickness burns. TheGlendale, N.Y., company will enroll 120 patients in the trial, whichwill be conducted at six burn centers in the U.S.The trial is being conducted under an FDA investigational deviceexemption, and the first patient was enrolled March 16 at Cornell-NewYork Hospital Burn Center in New York. A parallel trial of 20 pediatricburn patients is being conducted by Ortec in Sydney, Australia, wherethe first patient was enrolled Feb. 17. A patent on the product wasissued Feb. 1.Under the protocol, Ortec is focusing on deep second- and third-degreeburns. But Ron Lipstein, Ortec's vice president of financing, toldBioWorld he believes the product has applications for wound healingin general (such as for skin ulcers and scar revisions), which thecompany will look at after current trials.Lipstein said the company is taking a "non-aggressive" approach in ascenario that calls for the product to be on the market in about threeyears: one year of patient enrollment, one year of patient follow-upand a year to get through the FDA's pre-market approval (PMA)process.CCS is a biologically active dressing made up of a biodegradablematrix seeded with epidermal and dermal cells derived from infantforeskins. It uses both epidermal and dermal cells introduced into aproprietary collagen sponge. The graft stimulates the patient's body toregenerate a real, whole, mature skin that is neither temporary norartificial, the company said.Lipstein said the product differs from others in development exceptOrganogenesis Inc.'s GraftSkin in that it is bilayered, having bothan external epidermal and an internal dermal layer, thereby eliminatingthe need to apply an epidermal layer by taking autographs of a patient'sown skin.The company was founded in 1991 by Mark Eisenberg, whose son wasborn with Epidermolysis Bullosa (EB), a rare genetic disease thatcauses the skin to be extremely fragile and to fall off with the slightestfriction, resulting in infection and often in early death. Since 1988 theproduct has been tested on 21 people in Australia, many of whom werechildren with EB.In addition to Organogenesis, Ortec's product is competing withAdvanced Tissue Sciences Inc.'s DermaGraft, LifeCell Corp.'sAlloDerm and BioSurface Technology Inc.'s Epicel, which has hadproblems in clinicals.

-- Jim Shrine

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