NCT00904501

Bone Marrow Autograft in Limb Ischemia

Cell Therapy in Critical Limb Ischemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: CHU de Reims · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

BALI (Bone marrow Autograft in Limb Ischemia) is a randomized double-blind trial comparing implantation of bone marrow - mononuclear cells versus placebo in patients presenting with critical leg ischemia and no surgical option. The main end point is the survival without major amputation 6 months after implantation. Biological studies are performed on bone marrow mononuclear cells (BM-MNC) to evaluate their angiogenic properties.

Detailed description

One hundred and ten patients with critical leg ischemia and no surgical option will be included. A bone marrow harvest (500 mL under general anaesthesia) is performed and BM-MNC are separated and concentrated (30 mL) for all included patients. For half of them, the BM-MNC are implanted on the same day whereas the others are implanted with a placebo cell-product (30 mL saline with 4 ml peripheral blood). For these patients the BM-MNC are cryo-conserved. Only the cell therapy unit, neither the patient, nor the clinician, know whether BM-MNC or placebo is implanted. The main end point is the survival without major amputation 6 months after implantation. After this delay it is possible to use previously cryo-conserved BM-MNC. Likewise biological studies are performed on BM-MNC: flow-cytometry analysis of progenitor cells content, proteins and mRNAs expression, induced angiogenesis in animal models.

Conditions

• Peripheral Vascular Diseases

Interventions

Type	Name	Description
PROCEDURE	Bone marrow harvest	Implantation of placebo
PROCEDURE	Bone marrow harvest	Implantation of bone marrow - mononuclear cells

Timeline

• Start date: 2009-03-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2009-05-19
• Last updated: 2016-03-08

Locations

15 sites across 1 country: France