Clinical trial NCT00904501: Bone Marrow Autograft in Limb Ischemia
Official title: Cell Therapy in Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Vascular Diseases
Keywords: Limb ischemia
Cell Therapy
Lead sponsor: CHU de Reims
Sponsor class: OTHER
Collaborators: name: Etablissement Français du Sang
First posted: 2009-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Unexplained haematological abnormality

Primary outcomes:
measure: Major amputation rate and mortality
timeFrame: 6 months
Secondary outcomes:
measure: Clinical symptoms and haemodynamical parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU
city: Besancon
country: France
facility: CHU
city: Bordeaux
country: France
facility: CHU
city: Bordeaux
country: France
facility: CHU
city: Caen
country: France
facility: CHU
city: Grenoble
country: France
facility: CHU
city: Lille
country: France
facility: CHU
city: Limoges
country: France
facility: CHU
city: Marseille
country: France
facility: CHU
city: Mulhouse
country: France
facility: Centre Hospitalier
city: Nancy
country: France
facility: CHU
city: Nantes
country: France
facility: CHU
city: Paris
country: France
facility: HEGP
city: Reims
country: France
facility: Chu Reims
city: Strasbourg
country: France
facility: Chu Strasbourg
Study officials:
affiliation: CHU REIMS FRANCE
name: Bernard PIGNON
role: STUDY_DIRECTOR
References: