CLI Clinical Trials
Advancing stem cell therapy to treat critical limb ischemia
Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease (PAD) caused by chronic inflammatory processes associated with atherosclerosis that result in markedly reduced blood flow to the legs, feet and hands. There are an estimated 10-12 million people with PAD in the United States and over 1 million people with CLI. To read more about critical limb ischemia, visit our critical limb ischemia information page in the Cardiovascular Disease Patients section of our website. Below is information about the status of Aastrom’s CLI clinical trials.
Status: Study Ended
Study design: Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter
Patients: Patients with CLI who have no revascularization options as confirmed by an independent, centralized Eligibility Review Committee (ERC). Patients must have tissue loss on their index leg at screening.
Purpose: To assess the efficacy and safety of ixmyelocel-T treatment compared with placebo (vehicle control) in patients with CLI. The primary objective is to assess the effect of treatment with ixmyelocel-T on amputation-free survival (AFS) at 12 months post-injection.
Locations: Approximately 80 sites in the United States
You may also view more complete information about this REVIVE-CLI (55-1009-1) study on ClinicalTrials.gov, a registry of clinical trials conducted in the United States and around the world.
Study design: Phase 2, randomized, placebo controlled, double-blind, parallel-group, multicenter
Patients: Patients with lower extremity CLI with persistent, recurring rest pain for ~2 weeks and/or ulceration or gangrene of the foot or toe; patients were to have infrainguinal occlusive disease with no options for revascularization.
Purpose: To assess the safety and efficacy of ixmyelocel-T treatment compared with placebo (vehicle control) in patients with CLI.
Locations: Multiple sites in the United States
Publications based on study: RJ Powell, A Comerota, S Berceli, et al. Interim analysis results from the RESTORE-CLI, a randomized, double-blind multicenter phase II trial comparing expanded autologous bone marrow-derived tissue repair cells and placebo in patients with critical limb ischemia. J Vas Surg 2011. This manuscript is not available outside of the journal; however, you may view the abstract on the Journal of Vascular Surgery website.
W Marston, RJ Powell, S Berceli, et al. Patient-Specific Cellular Therapy (Ixmyelocel-T) is Safe and Improves Time to Treatment Failure in Patients with Critical Limb Ischemia and No Revascularization Options. Circulation. 2011; 124: A8547. This manuscript is not available outside of the journal; however, you may view the abstract on the Circulation website, and the full presentation on the Aastrom News and Events tab on the website.
RJ Powell, W Marston, S Berceli, et al. Cellular therapy with ixmyelocel-T to treat critical limb ischemia: the randomized, double-blind, placebo-controlled RESTORE-CLI trial. RJ Powell, W Marston, S Berceli, et al. Cellular therapy with ixmyelocel-T to treat critical limb ischemia: the randomized, double-blind, placebo-controlled RESTORE-CLI trial. Molecular Therapy 20, 1280-1286 (June 2012)