Bone Marrow Autograft in Limb Ischemia (BALI)

CHU de Reims

Status and phase: Completed; Phase 3

Conditions: Peripheral Vascular Diseases

Treatments: Procedure: Bone marrow harvest

Study type: Interventional

Funder types: Other

Identifiers

NCT00904501

PHRC2007- N11-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Bone marrow harvest

Procedure: Bone marrow harvest

B

Experimental group

Description:

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

Treatment:

Procedure: Bone marrow harvest

Procedure: Bone marrow harvest