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SBIR-STTR-Success: Skin Substitute Under Investigation to Reduce Need for Skin Graft

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Post Date:
March 30, 2021
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United States
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Severe burns can be life-threatening—but the standard treatment for burns requires an autograft, causing the patient additional wounds, slicing away a piece of healthy skin from elsewhere on the patient’s body and applying it to the damaged region. Skin grafting is also done for other causes of traumatic skin loss, or extensive skin infections such as diabetic ulcers and necrotizing fasciitis.

“While the grafting procedure works,” says Allen Comer, the Senior Director, Research, Strategy and Innovation at Stratatech, a Mallinckrodt company, “it creates a very painful donor site wound that contributes to the overall wound burden of the patient and causes morbidity. We're developing StrataGraft® skin tissue as an alternative that can eliminate the need to create a donor site in most patients.”

A skin tissue substitute, StrataGraft® skin tissue is made of cells the human body naturally produces, that can be used in place of a skin graft to encourage healing of a wound. Stratatech, in Madison, Wisconsin, has been developing the product for 20 years. And after joining Mallinckrodt Pharmaceuticals in 2016, their product is on the cusp of commercialization.

A skin tissue substitute, StrataGraft® skin tissue is made of cells the human body naturally produces, that can be used in place of a skin graft to encourage healing of a wound.

StrataGraft® skin tissue is based on research from Dr. Lynn Allen-Hoffmann’s lab at the University of Wisconsin-Madison. She and her team discovered a line of keratinocyte cells, the human skin cells that migrate across a wound to close it. The cell line was especially long-living in a culture environment, serving as a consistent source of keratinocytes for the manufacture of StrataGraft® skin tissue.

A rectangular sheet of skin, StrataGraft® skin tissue is similar to what a surgeon would harvest from a donor site. It is even “meshed,” or dotted with slits, just like an autograft is when it’s prepared for surgical use. “That was our goal,” Comer says, “to make something that really would fit naturally within a burn surgeon’s practice.”

StrataGraft® skin tissue is applied to a burn wound and left in place. Its presence protects the wound while it heals, and the keratinocytes promote healing by patient’s own cells. A preliminary study showed that once the wound healed, there was no evidence of StrataGraft® skin tissue remaining. Stratatech has finished a phase III clinical study, saying the results were “very promising.” The data is currently under review by U.S. Food and Drug Administration.

“We are doing everything we can to develop and make StrataGraft skin tissue available to patients, subject to FDA approval,” Comer says. “And the SBIR (Small Business Innovation Research) grants from the NIH,” specifically from the National Institute of Arthritis and Musculoskeletal Diseases and the National Institute of General Medical Sciences, “were critical to really allow us to get the technology started.”

Stratatech has also received SBIR grants to make more specialized skin constructs: funding from National Institute of Diabetes and Digestive and Kidney Diseases supported the development of a product for diabetic ulcers, and the National Institute of Allergy and Infectious Diseases funded a grant to develop a product for skin cancers.

“Stratatech is really tremendous evidence of public-private partnership to advance science,” says Derek Naten, the executive director of Government Affairs and Advocacy at Mallinckrodt.

The late-stage development of StrataGraft® skin tissue has been funded in part with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500027C.

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