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Bone Marrow Autograft in Limb Ischemia

NCT00904501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-03-08

No results posted yet for this study

Summary

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.

Conditions

  • Peripheral Vascular Diseases

Interventions

PROCEDURE

Bone marrow harvest

Implantation of placebo

PROCEDURE

Bone marrow harvest

Implantation of bone marrow - mononuclear cells

Sponsors & Collaborators

  • Etablissement Français du Sang

    collaborator OTHER

  • CHU de Reims

    lead OTHER

Principal Investigators

  • Bernard PIGNON · CHU REIMS FRANCE

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00904501 on ClinicalTrials.gov