Apligraf Cell Therapy Matches Standard Treatment of Excision Wounds

By Heidi Splete

CHICAGO -- The quality of healed wounds treated with bilayered cell therapy equaled that of wounds treated with a standard dressing in a randomized, multicenter study of 172 patients, Vincent Falanga, M.D., reported at the annual meeting of the Wound Healing Society.

Apligraf, a wound dressing based on bilayered cell therapy (BLCT), is approved by the Food and Drug Administration for the treatment of both venous leg ulcers and diabetic foot ulcers, and has been associated with fewer amputations and osteomyelitis in ulcer patients. These results suggest it is appropriate for excisional wounds as well as ulcers, said Dr. Falanga, professor of dermatology and biochemistry at Boston University.

The patients, aged 18-85 years, underwent either Mohs or excisional surgery for skin cancer. Patients with facial wounds were excluded from the study. The average area of the wounds was 821 mm2 in the BLCT group and 715 mm2 in the control group, and the average wound depth was 4 mm for both groups.

The BLCT patients received an application of BLCT mesh, followed by a tie-over, a semiocclusive dressing, and a conforming bandage, while the control group received a similar dressing and bandage without the mesh.

A total of 84 patients were treated with BLCT, and 88 were treated with standard dressings.

The primary efficacy end point was the quality of the healed wound. Wound quality was assessed using the Vancouver Burn Scar Assessment Scale, in which the investigator and an independent observer rate the wound on a scale of 0 (no scar) to 15 (worst scar). Overall, 57 of the 84 BLCT patients received scores of 4 or less from both the investigator and the observer. By comparison, 60 and 54 of the 88 control patients were assigned scores of 4 or less by the investigator and the observer, respectively.

BLCT was safe and well tolerated, and no significant difference in healing times was seen between patients treated with BLCT and controls. Neither group experienced significant adverse events or rapid cancer recurrence.

Dr. Falanga has received grant support from and consulted for Novartis Pharmaceuticals Corp. and Organogenesis Inc.