Date: 2014-09-15
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the joint annual meeting of the Eastern Vascular Society and the New England Society for Vascular Surgery .
Company: Osiris Therapeutics (USA - MD)
Product: Grafix®
Action
mechanism: Grafix® is a cryopreserved placental membrane for acute and chronic wounds. It is a flexible, conforming membrane that is applied directly at the site of the wound. Grafix is produced by Osiris\' BioSmart™ Intelligent Tissue Processing which maintains the integrity of the extracellular matrix, growth factors, and endogenous fibroblasts, epithelial cells and mesenchymal stem cells of the native tissue.
Disease: chronic venous ulcers
Therapeutic area: Cardiovascular diseases
Country:
Trial details:
Latest
news: * On September 15 2014, Osiris Therapeutics announced that data from an evaluation of Grafix® in the treatment of chronic venous leg ulcers (VLUs) was presented on Sunday September 14th, at the joint annual meeting of the Eastern Vascular Society and the New England Society for Vascular Surgery . The data, presented by Shahab Toursavadkohi, MD, Assistant Professor of Vascular Surgery at the University of Maryland School of Medicine , highlighted the initial experience of Grafix® in the treatment of chronic venous ulcers of at least 12 weeks duration that failed standard compression therapy for at least 6 weeks. Patients with an active infection were excluded from treatment. The interim study analysis evaluated 18 wounds treated with Grafixv and compression therapy compared to 13 case matched control wounds with similar wound area and wound age treated with standard compression therapy alone. Overall healing rates in the Grafix patients were 50% compared to 15.4% in the control group (p < 0.05). In addition, patients in the Grafix® group had significantly reduced mean time to complete healing (11.9 weeks vs 29.9 weeks, p < 0.05) and mean length of therapy (12.6 weeks vs 106.3 weeks, p=0.015) compared to the compression only group. The on-going evaluation will include up to 50 total patients.
