Cell Therapy in Critical Limb Ischemia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Diseases
- Sponsor
- CHU de Reims
- Enrollment
- 40
- Locations
- 5
- Primary Endpoint
- Major amputation rate and mortality
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
PIGNON
MD
CHU de Reims
Eligibility Criteria
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
Outcomes
Primary Outcomes
Major amputation rate and mortality
Time Frame: 6 months
Secondary Outcomes
- Clinical symptoms and haemodynamical parameters(6 months)