Regenerative medicine company Stratatech Corp. has been awarded $4.6 million by the National Institute of Diabetes and Digestive and Kidney Diseases. The grant will fund the first human clinical trial of Stratatech's ExpressGraft antimicrobial skin substitute, a potential treatment for chronic diabetic foot ulcers.
The clinical trial will assess the safety and efficacy of the tissue, which is the first therapeutic skin substitute to be genetically enhanced to fight infection and accelerate wound healing.
ExpressGraft skin substitute is a living, cell-based tissue with the physical, chemical and histological characteristics of human skin. When applied topically to non-healing ulcers, this tissue provides immediate wound closure and is expected to be gradually replaced by the patient's own cells during the wound healing process. The tissue's ability to produce an immune system protein enables it to fight infections that routinely develop at the site of diabetic foot ulcers.
"Stratatech will advance its second therapeutic product into clinical testing with this award, bringing us another step closer to the multibillion dollar market for chronic skin ulcer treatments," said Lynn Allen-Hoffmann, Ph.D., Stratatech's chief executive and chief scientific officer. "This competitive, peer-reviewed award is another validation of the compelling value of our portfolio of genetically enhanced skin substitutes."
Chronic diabetic foot ulcers are a major and rapidly growing healthcare concern. More than 23 million people in the United States have diabetes and an estimated 900,000 new patients are afflicted with non-healing skin ulcers each year.
Diabetic lesions are responsible for more hospitalizations than any other complication of diabetes and lead to more than 80,000 amputations each year. First-generation human skin substitutes are available to help close chronic wounds, but those skin substitutes are not approved for use in infected wounds, are not effective in many patients and do not fight infection.