According to Globes [online], Israeli company Ortec International Inc. has successfully completed trials of its OrCel wound sealant.
Ortec said, “OrCel healed more wounds and achieved 100% wound closure of those wounds sooner in comparison to the control group.” The company will submit the trial results to the US Food and Drug Administration (FDA) and hopes to receive a reply by year end…
The product closes difficult wounds, such as skin ulcers in limbs or from diabetes, using a collagen matrix with embedded cells that form skin cells. The material is kept chilled, in contrast to OrCel, which is frozen and therefore easier and cheaper to transport.
Here’s the company explains its technology:
OrCel® is a bilayered cellular matrix in which normal human allogeneic skin cells (epidermal keratinocytes and dermal fibroblasts) are cultured in two separate layers into a Type I bovine collagen sponge. Donor dermal fibroblasts are cultured on and within the porous sponge side of the collagen matrix while keratinocytes, from the same donor, are cultured on the coated, non-porous side of the collagen matrix…
OrCel®’s first FDA approvals were obtained last year for treatment of acute surgical excisions, such as contracture release sites and donor sites in Epidermolysis Bullosa patients undergoing hand reconstruction surgery and donor sites in burn victims undergoing excision and autografting. Since the cells used to produce OrCel® are extensively expanded in vitro, they cease to express significant levels of HLA-II antigens and, upon application to a wound bed, are apparently not immediately recognized by the recipient’s immune system as foreign.
This has been confirmed in both clinical trial and commercial experience, as no clinical observations of signs of tissue rejection have ever been reported. In addition, in a recent pilot study with the experimental cryopreserved OrCel® product, no HLA-cytolytic antibody response to alloantigens in the product was detected in a cohort of 13 patients after four sequential weekly product applications. Resorption appears to take place gradually, with no remnants of the donor cells or matrix being detectable by two weeks post-treatment. Our working hypothesis is that extracellular secretion of cytokines and growth factors by the living cells in OrCel® is a major contributing factor to the product’s ability to accelerate wound healing.