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Bone Marrow Autograft in Limb Ischemia (BALI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by CHU de Reims.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014