Apligraf Human Skin Indications To Be Extended

Organogenesis of the USA presented results of a two-year clinical trialof its Apligraf (Graftskin) human skin substitute in patients with burns at the Bioengineering of Skin Substitutes meeting, held earlier this month in Boston, Massachusetts. The data from the study show that Apligraf, when used in conjunction with an autograft of the patient's own skin results in less scarring and more normal pliability when compared with an autograft alone.

Clinical studies of Apligraf have now been completed in venous ulcers, burns, dermatological surgery wounds and donor site wounds, and a study is underway in diabetic ulcers. The product has been approved and launched for the treatment of venous ulcers in Canada, and an application for this indication is currently pending at the US Food and Drug Administration. Organogenesis' marketing partner for the product is Swiss firm Novartis, and additional international registrations for the product are being pursued by the two firms, including in Europe.

Severe Burns Study Is Positive The new two-year trial studied the effect of Apligraf on 40 patients with severe burns. The trial had a six-month efficacy phase plus an 18-month follow-up phase. Each patient served as his or her own control. 28 patients completed the six-month efficacy phase of the study, and 17 completed the two-year follow-up phase.