Bone Marrow Autograft in Limb Ischemia

Phase 3

Completed

• Conditions: Peripheral Vascular Diseases
• Interventions: Procedure: Bone marrow harvest

• Registration Number: NCT00904501
• Lead Sponsor: CHU de Reims

Brief 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-05
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Critical limb ischemia
• No possible surgical treatment

Exclusion Criteria

• Ongoing infectious disease
• Gangrene extending beyond the digits
• Diabetes mellitus with HbA1c > 7.5% or with proliferative retinopathy
• History of malignant disease
• Contra-indication to general anaesthesia
• Chronic haemodialysis
• Prothrombin Time < 50%
• Recent onset (within 3 months) of myocardial infarction or brain infarction
• Contra-indication to modification of anti-platelet or anticoagulant therapy
• History of heparin-induced thrombocytopenia
• Unexplained haematological abnormality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Bone marrow harvest	A bone marrow harvest (500 mL under general anaesthesia) is performed and BM-MNC are separated and concentrated (30mL) . The BM-MNC are implanted on the same day. Only the cell therapy unit, neither the patient, nor the clinician, know whether BM-MNC or placebo is implanted
A	Bone marrow harvest	A bone marrow harvest (500 mL under general anaesthesia) is performed and BM-MNC are separated and concentrated (30mL). A placebo cell-product (30 mL saline with 4 ml peripheral blood) is implanted and 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. After 6 months, it is possible to use previously cryo-conserved BM-MNC.

Primary Outcome Measures

Name	Time	Method
Major amputation rate and mortality	6 months

Secondary Outcome Measures

Name	Time	Method
Clinical symptoms and haemodynamical parameters	6 months

Trial Locations

Locations (5)

CHU; 🇫🇷 Nantes, France

HEGP; 🇫🇷 Paris, France

Centre Hospitalier; 🇫🇷 Mulhouse, France

Chu Reims; 🇫🇷 Reims, France

Chu Strasbourg; 🇫🇷 Strasbourg, France