A Cellular Matrix That Closes Difficult Wounds

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. Since the cells used to produce OrCel are extensively expanded in vitro, they cease to express significant levels of human leukocyte antigen 2 (HLA-2) and, upon application to a wound bed, are apparently not immediately recognized by the recipient's immune system as foreign.

The absorbable biocompatible matrix provides a favorable environment for host cell migration and has been shown to contain various cell-expressed cytokines and growth factors. The product is not intended to be a human skin replacement and does not contain Langerhans cells, melanocytes, macrophages, lymphocytes, blood vessels, or hair follicles. Resorption appears to take place gradually, with no remnants of the donor cells or matrix being detectable by two weeks post-treatment. The 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.

The OrCel matrix was developed by Ortec International (New York, NY, USA). It can be cryopreserved and recovers full potency upon thawing, providing an off-the-shelf wound treatment option, available on demand at point of use.

Approval by the U.S. Food and Drug Administration (FDA) was obtained in 2005 for the treatment of acute surgical excisions--such as contracture release sites--and donor sites such as in epidermolysis bullosa patients undergoing hand-reconstruction surgery, or burn victims undergoing excision and autografting. In addition, the FDA has granted Ortec approval to initiate a phase 3 trial evaluating OrCel for the treatment of diabetic foot ulcers.



Related Links:
Ortec International