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Bone Marrow Autograft in Limb Ischemia (BALI)

This study has been completed.
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 5, 2016
Last verified: March 2016
  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
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

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 ]

Enrollment: 40
Study Start Date: March 2009
Study Completion Date: January 2015
Primary Completion Date: January 2015 (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   (Adult, Senior)
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
Amiens, France, 80054
CHU
Besancon, France, 25030
CHU
Bordeaux, France, 33075
CHU
Bordeaux, France, 33604
CHU
Caen, France, 14033
CHU
Grenoble, France, 38043
CHU
Lille, France, 59037
CHU
Limoges, France, 87000
CHU
Marseille, France, 13005
Centre Hospitalier
Mulhouse, France, 68100
CHU
Nancy, France, 54511
CHU
Nantes, France, 44035
HEGP
Paris, France, 75908
Chu Reims
Reims, France, 51092
Chu Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
CHU de Reims
Etablissement Français du Sang
Investigators
Study Director: Bernard PIGNON CHU REIMS FRANCE
  More Information

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 5, 2016
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 September 23, 2016