Stratatech Initiates Second Clinical Trial of StrataGraft® Skin Substitute
MADISON, Wis.–(BUSINESS WIRE)–Stratatech Corp., a leader in regenerative medicine, today announced that it has initiated its second multicenter clinical trial of the company’s StrataGraft® skin substitute. The clinical trial will assess the safety and clinical utility of the StrataGraft® skin substitute in the long-term treatment of patients with severe second-degree burns.
“We achieved our primary endpoints during StrataGraft’s Phase I clinical trial, which were related to safety and efficacy, and obtained important insights into the immunological response of patients with severe third-degree burns”
StrataGraft® skin substitute is a living, cell-based tissue with the physical, chemical and histological characteristics of human skin. The company believes that once the StrataGraft® tissue is applied to a wound, it will restore the critically needed protective barrier lost with the burned skin tissue, accelerate wound healing and be gradually replaced by the patient’s own cells.
There is an urgent need for new burn treatment options. An estimated 1.1 million Americans suffer burns each year, according to the American Burn Association. Approximately 45,000 of these patients are hospitalized for treatment. Their severe burns are life-threatening injuries that require immediate surgical intervention. This intervention typically involves temporary coverage of the wound site with cadaver skin or synthetic dressings in an attempt to prevent infection and dehydration, as there are no full-thickness skin substitutes commercially available for this indication. The clinical trial initiated recently by Stratatech is the next step in the company’s effort to commercialize a living human skin substitute to fill that unmet need.
“We achieved our primary endpoints during StrataGraft’s Phase I clinical trial, which were related to safety and efficacy, and obtained important insights into the immunological response of patients with severe third-degree burns,” said Lynn Allen-Hoffmann, Ph.D., Stratatech’s chief executive and chief scientific officer. “Our second clinical study will enable us to assess in a larger number of patients the longer term safety of StrataGraft, endpoints related to the tissue’s wound-healing function and the cosmetic characteristics of the treated site.”
About Stratatech Corp.
Stratatech Corp. is a privately-held regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products for therapeutic and research applications. These products are made using the company’s proprietary NIKS® cells, a human keratinocyte progenitor cell line that faithfully reproduces normal epidermal skin architecture and barrier function. Stratatech is using its progenitor cell line to build a portfolio of therapeutic products to treat severe burns, non-healing skin ulcers and other complex skin defects. For more information about Stratatech, its technology and product pipeline, please visit the company’s website at www.stratatechcorp.com.
Lynn Allen-Hoffmann Ph.D.
Chief Executive and Chief Scientific Officer,
The Luminis Group, Ltd.
for Stratatech Corp.
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