Bone Marrow Autograft in Limb Ischemia (BALI)
This study is currently recruiting participants.
Verified March 2012 by CHU de Reims
Sponsor:
CHU de Reims
Collaborator:
Etablissement Français du Sang
Information provided by (Responsible Party):
PIGNON, CHU de Reims
ClinicalTrials.gov Identifier:
NCT00904501
First received: May 18, 2009
Last updated: March 12, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Vascular Diseases Limb Ishemia |
Procedure: Bone marrow harvest |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Cell Therapy in Critical Limb Ischemia |
Resource links provided by NLM:
Further study details as provided by CHU de Reims:
Primary Outcome Measures:
- Major amputation rate and mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical symptoms and haemodynamical parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: A
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.
|
Procedure: Bone marrow harvest
Implantation of placebo
|
|
Experimental: B
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
|
Procedure: Bone marrow harvest
Implantation of bone marrow - mononuclear cells
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904501
Locations
| France | |
| CHU | Recruiting |
| Amiens, France, 80054 | |
| Contact: Marie Antoinette SEVESTRE, MD sevestre.marie-antoinette@chu-amiens.fr | |
| CHU | Recruiting |
| Besancon, France, 25030 | |
| Contact: GABRIEL CAMELOT gcamelot@chu-besancon.fr | |
| CHU | Recruiting |
| Bordeaux, France, 33075 | |
| Contact: JOEL CONSTANS joel.constans@chu-bordeaux.fr | |
| CHU | Recruiting |
| Bordeaux, France, 33604 | |
| Contact: LAURENT BARANDON laurent.barandon@chu-bordeaux.fr | |
| CHU | Not yet recruiting |
| Caen, France, 14033 | |
| Contact: CLAIRE LE HELLO lehello-c@chu-caen.fr | |
| CHU | Recruiting |
| Grenoble, France, 38043 | |
| Contact: GILLES PERNOD GPernod@chu-grenoble.fr | |
| CHU | Not yet recruiting |
| Lille, France, 59037 | |
| Contact: SOPHIE SUZEN sophiesusen@aol.com | |
| Sub-Investigator: ERIC VANVELLE | |
| CHU | Recruiting |
| Limoges, France, 87000 | |
| Contact: FRANCIS PESTEIL francis.pesteil@chu-limoges.fr | |
| CHU | Recruiting |
| Marseille, France, 13005 | |
| Contact: FRANCOISE DIGNAT-GEORGE francoise.dignat-george@mail.ap-hm.fr | |
| Sub-Investigator: ALAIN BRANCHEREAU | |
| Centre Hospitalier | Recruiting |
| Mulhouse, France, 68100 | |
| Contact: MARIO OJEDA-URIBE ojedam@ch-mulhouse.fr | |
| Sub-Investigator: AMER HAMADE | |
| CHU | Not yet recruiting |
| Nancy, France, 54511 | |
| Contact: ANNA KEARNEY-SCHWARTZ a.kearney-schwartz@chu-nancy.fr | |
| Sub-Investigator: JEAN-PIERRE VILLEMOT | |
| CHU | Recruiting |
| Nantes, France, 44035 | |
| Contact: PATRICIA LEMARCHAND patricia.lemarchand@nantes.inserm.fr | |
| Sub-Investigator: YANN GOUEFFIC | |
| Sub-Investigator: GEROME CONNAULT | |
| HEGP | Not yet recruiting |
| Paris, France, 75908 | |
| Contact: JOSEPH EMMERICH joseph.emmerich@egp.ap-hop-paris.fr | |
| Chu Reims | Recruiting |
| Reims, France, 51092 | |
| Contact: BERNARD PIGNON bpignon@chu-reims.fr | |
| Sub-Investigator: CLAUDE CLEMENT | |
| Chu Strasbourg | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: DOMINIQUE STEPHAN dominique.stephan@chru-strasbourg.fr | |
Sponsors and Collaborators
CHU de Reims
Etablissement Français du Sang
Investigators
| Study Director: | Bernard PIGNON | CHU REIMS FRANCE |
More Information
No publications provided
| Responsible Party: | PIGNON, MD, CHU de Reims |
| ClinicalTrials.gov Identifier: | NCT00904501 History of Changes |
| Other Study ID Numbers: | PHRC2007- N11-02 |
| Study First Received: | May 18, 2009 |
| Last Updated: | March 12, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by CHU de Reims:
|
Limb ischemia Cell Therapy |
Additional relevant MeSH terms:
|
Ischemia Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Pathologic Processes |
Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on June 18, 2013