That's the conclusion of a new study conducted in part at the University of North Carolina School of Medicine and published online by The Lancet this week.
The Phase II clinical trial, which investigates the efficacy of HP802-247 from Healthpoint® Biotherapeutics, was designed to determine effectiveness of certain cell concentrations and dosing frequencies of HP802-247, when combined with standard care in treatment of chronic venous leg ulcers.
William Marston, MD, professor of surgery in the UNC School of Medicine and medical director of the UNC Wound Healing Clinic, is an investigator in the study and one of the article authors.
Venous leg ulcers are caused by impaired circulation in the vein system of the legs from blockages or damage. Typically, venous leg ulcers become chronic wounds if, after three months of standard treatment, they fail to heal. Chronic venous leg ulcers appear as open lesions and need specialized medical care. An estimated 1-2 million Americans suffer from venous leg ulcers.
HP802-247 is a living human cell formula consisting of skin cells (keratinocytes and fibroblasts), which release growth factors into the wound on a cellular level for tissue regeneration, along with fibrinogen, which forms a "cellular web" for blood clotting and elasticity. During the study, 228 patients were enrolled at 28 medical centers in the United States, including UNC. Two different cell concentrations and two separate dosing frequencies were tested with standard care, in addition to a control group, over a 12-week period.
Dr. Marston says, "In the past, some chronic venous leg ulcers were treated with skin grafts, which occasionally could break down and also required the patient to heal a partial thickness wound at the skin graft harvest site. During this study, unique living cells were sprayed on the patient's wound, which interacted with the patient's cells for improved wound healing."
"In the study, we determined the best dosing of the fibroblast/keratinocyte preparation that markedly accelerated the rate of healing of the wounds. We are currently preparing a Phase III pivotal trial to start late this year," adds Dr. Marston.
The citation for the Phase II study manuscript is: Kirsner RS, Marston WA, Snyder RJ, Lee TD, Cargill DI, Slade HB. A Multicentre Randomised Dosing Trial of Spray-Applied Cell Therapy With Human Allogeneic Fibroblasts and Keratinocytes for the Treatment of Chronic Venous Leg Ulcers. Lancet 2012; pending.
The study was funded by Healthpoint® Biotherapeutics.
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