A team of researchers from Organogenesis published a tissue-graft study in the peer review journal Transplantation that acompany spokeswoman called "very important for thecredibility of our product."
The article, "Neutral Allografts -- Lack of AllogeneicStimulation by Cultured Human Cells Expressing MHC Class Iand Class II Antigens," establishes that human dermalfibroblasts, epidermal cells and smooth muscle cells fail toactivate T cells, a critical step in recognition of foreign cellsleading to graft rejection.
Organogenesis (AMEX:ORG) of Canton, Mass., uses tissueengineering technology to develop replacement skin andorgans.
"People have been saying you can't use epidermal cells becauseyou'll get rejection," said spokeswoman Jennifer Pierce. "Theyused to say you couldn't use dermal cells, but that's beendisproven over the years."
The research, by Valerie Theobald and co-workers, suggeststhat the failure to elicit a T cell response may be due to thelack of undefined factors, such as cytokines.
Organogenesis has its own patented technology for extractingand manufacturing collagen in braids, rods and sheets. TuftsUniversity is conducting a feasibility study for using collagencables to replace torn knee ligaments, Pierce said. The bodyremodels the collagen, which acts as a scaffold for cells.
The Transplantation journal study implies that fibroblasts,smooth muscle cells and epidermal cells can serve as buildingblocks for engineered grafts that will not induce rejection.
"These findings clearly support our scientific observationsregarding the lack of immune response or rejection in patientswho have received Graftskin (a living skin equivalent)," saidThomas Tully, president and chief operating officer. More than70 patients at 15 centers in the U.S. have been treated withthis dual-layer product to replace skin lost in wounds andburns. None have shown any adverse reaction or immuneresponse.
The company has permission to conduct efficacy trials in up to600 patients in burns, clean excisions and chronic venousulcers, Pierce said. However, a pre-market application could besubmitted to FDA on fewer cases, depending on results of thestudies.
The company's competitors, BioSurface Technologies Inc. ofCambridge, Mass., and Advanced Tissue Sciences Inc. of LaJolla, Calif., have products based on epidermal or dermal cells,respectively, but do not include collagen.
-- Nancy Garcia Associate Editor
(c) 1997 American Health Consultants. All rights reserved.