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

Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose

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).

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.

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+

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