Reminder: Interim Vascular Trial Results, to be Presented at Society for Vascular Surgery Annual Meeting, Aastrom Biosciences (ASTM)
Reminder; Interim results from ASTM’s US Phase 2b RESTORE-CLI trial will be presented by the principal investigator, Richard J. Powell, MD, section chief of vascular surgery at the Dartmouth-Hitchcock Medical Center in Lebanon, NH at the 2010 Vascular Annual Meeting on 6/11/10 in Boston, MA.
Dr. Powell’s presentation, entitled “Interim Results from a Randomized, Placebo Controlled, Double-blind Multi-center Phase II Trial Comparing Expanded Autologous Bone Marrow in Patients with Critical Limb Ischemia,” will further describe the interim results based on data from 46 patients enrolled in the RESTORE-CLI trial.
Reiterating, RESTORE-CLI is the largest double-blind, randomized cell therapy study to be conducted for critical limb ischemia or CLI, the end-stage of peripheral arterial disease. The purpose of this trial has been to assess the safety and clinical efficacy of ASTM’s tissue repair cells (TRCs) in the treatment of CLI in patients with no revascularization options. While the primary objective of the trial has been to assess safety in patients with CLI, additional efficacy measures have been monitored, including time to treatment failure (where failure is defined as major amputation, doubling of wound size or new gangrene), amputation rate, wound size and severity.
Critical limb ischemia can be a deadly serious disease with very few treatment options. Aside from the amputation risk these patients face, more than 20% of CLI patients will die within 12 months of disease onset. In 2/10 ASTM reported highlights from a planned analysis of RESTORE-CLI interim data. The final patient treatment in this trial occurred in March.
Approximately 1 M people in the US suffer from CLI.
