Status:
COMPLETED
Bone Marrow Autograft in Limb Ischemia
Lead Sponsor:
CHU de Reims
Collaborating Sponsors:
Etablissement Français du Sang
Conditions:
Peripheral Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ische...
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 conc...
Eligibility Criteria
Inclusion
- Critical limb ischemia
- No possible surgical treatment
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00904501
Start Date
March 1 2009
End Date
January 1 2015
Last Update
March 8 2016
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU
Amiens, France, 80054
2
CHU
Besançon, France, 25030
3
CHU
Bordeaux, France, 33075
4
CHU
Bordeaux, France, 33604