CLI Clinical Trials
Critical limb ischemia (CLI) is a severe type of peripheral arterial disease (PAD) that results from markedly reduced blood flow to the hands, legs, and feet. There are an estimated 5 million people with PAD in the United States and 1 million people with CLI. To read more about critical limb ischemia, visit our critical limb ischemia information page in the For Patients section of our website. Below is information about the status of Aastrom’s CLI clinical trials.
Clinical Trial Information for Critical Limb Ischemia
Status: Active not enrolling patients
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: R 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; e-pub ahead of press.
You may also view more complete information about this Restore-CLI (55-0610-1) study on ClinicalTrials.gov, a registry of clinical trials conducted in the United States and around the world.
Clinical Trial Information for Critical Limb Ischemia
REVIVE-CLI (55-1009-1)
Status: In development, not enrolling. Special Protocol Assessment concordance with FDA in July 2011. Planned enrollment beginning fourth quarter 2011.
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, central 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: Multiple sites in the United States
Publications based on study: Not applicable