Bone Marrow Autograft in Limb Ischemia (BALI)

March 5, 2016 updated by: PIGNON, CHU de Reims

Cell Therapy in Critical Limb Ischemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU
      • Besancon, France, 25030
        • CHU
      • Bordeaux, France, 33604
        • CHU
      • Bordeaux, France, 33075
        • CHU
      • Caen, France, 14033
        • CHU
      • Grenoble, France, 38043
        • CHU
      • Lille, France, 59037
        • CHU
      • Limoges, France, 87000
        • CHU
      • Marseille, France, 13005
        • CHU
      • Mulhouse, France, 68100
        • Centre hospitalier
      • Nancy, France, 54511
        • CHU
      • Nantes, France, 44035
        • CHU
      • Paris, France, 75908
        • HEGP
      • Reims, France, 51092
        • Chu Reims
      • Strasbourg, France, 67091
        • CHU Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: Bone marrow harvest
Implantation of bone marrow - mononuclear cells
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 placebo
Procedure: Bone marrow harvest
Implantation of bone marrow - mononuclear cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major amputation rate and mortality
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical symptoms and haemodynamical parameters
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Collaborators

Etablissement Français du Sang

Investigators

  • Study Director: Bernard PIGNON, CHU REIMS FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

May 18, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 19, 2009

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 5, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC2007- N11-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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