Advanced Tissue Sciences Inc. (ATS) has filed for aninvestigational device exemption with the FDA to conduct apilot clinical trial of DermaGraft-TC (DermaGraft-transitionalcovering). The trial, expected to begin in early 1994, will followpatients for 12 weeks.
DermaGraft-TC, a living dermal tissue combined with atemporary synthetic epidermal layer, is designed to retainfluids and prevent infections until the patient's own skin canbe used for grafting. ATS (NASDAQ:ATIS) of La Jolla, Calif., saidit is designed to serve as an alternative to human cadaver skinas a transitional covering in patients with severe burns.DermaGraft-TC could offer "several advantages over cadaverskin, such as patient safety, longer-term wound coverage, noimmunological rejection and availability in large amounts," thecompany said.
Kirby Black, ATS's director of medical information, saidDermaGraft-TC has the same cellular and matrix components asthe company's DermaGraft, but that the two are used atdifferent times. DermaGraft, currently in clinical trials, isintended for use in conjunction with autograft to providesupport for skin grafts.
FDA issued an interim rule in the Dec. 14 Federal Registerrequiring tissue banks to conduct testing for certain infectiousdiseases, and donor screening and record-keeping to helpprevent the transmission of AIDS and hepatitis through humantissue used in transplantation.
Black said this requirement will affect the ability of tissuebanks to procure and maintain the same amount of allograftskin. He noted that there have been one or two documentedcases of HIV transmission from skin grafts. -- Brenda Sandburg
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