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

IRB Number

11-098

ClinicalTrials.gov Identifier

NCT01483898

Trial Status

Open for Enrollment
Phase 3

Why is this study being done?

The main purpose of this study is to determine the effectiveness and safety of ixmyelocel-T compared to placebo (an inactive solution, like a sugar pill) when given to patients with critical limb ischemia (CLI) who have no options for surgery to fix their disease.

Who is eligible to participate?

People between the ages of 35 and 90 who have been diagnosed with critical limb ischemia.

What is involved?

Patients will have a physical examination, blood samples will be taken, an ECG will be performed, photographs of any leg wounds will be done, and the patient will be sent for an eye examination. Eligible patients will then undergo a bone marrow aspiration (bone marrow is drawn from your hip bone). Approximately two weeks later, patients will return to the clinic for injection of the stem cells collected from the bone marrow. There will be 20 injections in the affected leg. They will receive a phone call four days after the injections and then return to the clinic for follow-up at one, three, six, nine, twelve, fifteen, and 18 months.

How long is the study?

The study has 10 visits spread over approximately 19 months.

Who can I contact for additional information?

Please contact Tiffany Whitaker, R.N., at (217) 545-2531 or email: twhitaker@siumed.edu

Who is the Principal Investigator of this study?

Doug Hood, MD

Where is the trial located?

Springfield, Illinois