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

Conditions

Critical Limb Ischemia

What is the purpose of this trial?

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.



Participation Guidelines

Age:
35 Years - 90 Years
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Aastrom Biosciences
Dates:
February 2012
Last Updated:
July 17, 2013
Study HIC#:
1107008853

Clinicaltrials.gov ID: NCT01483898