Bone Marrow Autograft in Limb Ischemia (BALI)

This study is currently recruiting participants.
Verified March 2012 by CHU de Reims
Sponsor:
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
  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 April 14, 2014