Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)

University of Paris 5 - Rene Descartes

Status and phase: Unknown; Phase 1

Conditions: Critical Leg Ischemia

Treatments: Procedure: cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00377897

OPTIPEC

Details and patient eligibility

About

This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).

Full description

Patients will be included with CLI according to the TASC criteria. Under general anesthesia, 500 ml of bone marrow is harvested in both iliac crests. After isolation and concentration of the BMMNC in 30 ml, 40 injections of around 0.75 ml will be done in the gastrocnemius of the ischemic leg, within 3 hours after preparation of the cell therapy product.

Patients will then be followed-up every week during one month and then every month during one year.

This study was approved by the ethical committee of Paris-Broussais HEGP (France) and our french regulatory agency (AFSSAPS).

It began including patients in January 2005 and will last until December 2007.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18
• Signature of informed consent
• Critical leg ischemia with ankle pressure < 70 mmHg
• Ischemic ulcer or gangrene
• No possibility of surgical revascularization
• No possibility of angioplasty

Exclusion criteria

• Cancer
• Suspicion of a cancer on X-Ray, mammography or elevated PSA
• Age < 18
• Life expectancy < 6 months
• Active retinopathy
• Angioplasty or surgical revascularization within 3 months
• Stoke within 3 months
• HIV + or HCV/HBC+

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)