NCT01483898

An Efficacy and Safety Study of Ixmyelocel-T in Patients With Critical Limb Ischemia (CLI)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Ixmyelocel-T In Subjects With Critical Limb Ischemia And No Options For Revascularization

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Vericel Corporation · Industry
• Sex: All
• Age: 35 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of ixmyelocel-T, a patient-specific expanded multicellular therapy, for the treatment of patients with critical limb ischemia (CLI). The study is a randomized, vehicle controlled (placebo)study in CLI patients who have no option for revascularization procedures. All patients randomized will undergo a small volume bone marrow aspiration in a 15-minute outpatient or in-office procedure. All patients will receive injections of either ixmyelocel-T or vehicle-control into their pre-identified index leg. Patients will be followed for 18 months.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
BIOLOGICAL	Ixmyelocel-T	On Day 14, 20 intramuscular injections of ixmyelocel-T on pre-identified index leg.
OTHER	Placebo	On Day 14, 20 intramuscular injections of vehicle control on pre-identified index leg.

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-03-25
• Completion: 2014-03-25
• First posted: 2011-12-02
• Last updated: 2021-05-27

Locations

86 sites across 1 country: United States