A University of Wisconsin–Madison spinoff that makes an innovative material designed to speed healing of serious burns has begun a large clinical trial for the “regenerative skin tissue” it has been developing since 2000.
Stratatech, now a Mallinckrodt Pharmaceuticals company, aims to prove to the Food and Drug Administration that the material, called StrataGraft, is safe and effective for treating severe burns. Intense burns can be painful, even deadly, because they destroy key protections against infection and dehydration.
Today, treatment involves removing a portion of the patient’s intact skin and grafting it to the burned site. In contrast, StrataGraft is designed to cover deep burns with a matrix containing human skin cells.
These cells, called keratinocyte progenitors, are able to form the epidermis, or top layers of skin. It is possible that the progenitor cells also produce and release growth factors that stimulate regeneration of the patient’s own skin cells, yet evoke a very limited immune response…
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Zdroj: Innovative skin replacement starts final clinical trial