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news.Fibrocell Science, an autologous cell therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, announced the US Food and Drug Administration is allowing the company's investigational new drug (IND) application to proceed for developing a new treatment for amputee stump skin to prevent skin diseases that lead to prosthesis abandonment.
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"We are proud and hopeful to play a role to develop a treatment that could potentially reduce the rate of prosthesis abandonment for those who have so honorably served our country, as my father did in the U.S. Marine Corps during World War II," said David Pernock, Chairman and Chief Executive Officer of Fibrocell.
By using autologous fibroblasts to help wounded warrior amputees, Fibrocell aims to address skin breakdown and pain at the stump site by promoting the skin properties found on the palms and soles.
Specifically, autologous volar fibroblasts will be used to re-program non-palmar/plantar skin to develop a thickened stratum corneum and express keratin-9. If successful, this technique should reduce the rate of prosthesis abandonment in wounded warriors and other people with amputations.
To support development of this program, Fibrocell has collaborated with Lt. Col. Jon Meyerle, MD, of the Uniformed Services University of the Health Sciences in submission of an invited application to the Peer Reviewed Orthopaedic Research Program Clinical Trial Award (DoD/CDMRP/PRORP) Grant.
This program is administered by the Congressionally Directed Medical Research Programs Office of the Department of Defense. Fibrocell would begin the program upon receipt of the grant.
"Prosthesis abandonment among amputees is due in large part to skin disease. We are working with Fibrocell on a clinical study to develop a novel treatment of amputee stump skin that could advance the quality of life of service members by improving the ‘wearability’ of their prosthetic devices," said Lt. Col. Meyerle, MD, Assistant Professor of Dermatology, USU, Residency Program Director, and Chief of Immunodermatology at Walter Reed National Military Medical Center.