NCT00904501

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_3

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

5.8 years

First QC Date

May 18, 2009

Last Update Submit

March 5, 2016

Conditions

Peripheral Vascular Diseases

Keywords

Limb ischemiaCell Therapy

Outcome Measures

Primary Outcomes (1)

  • Major amputation rate and mortality

    6 months

Secondary Outcomes (1)

  • Clinical symptoms and haemodynamical parameters

    6 months

Study Arms (2)

A

PLACEBO COMPARATOR

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

B

EXPERIMENTAL

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

Interventions

Bone marrow harvestPROCEDURE

Implantation of placebo

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Critical limb ischemia
  • No possible surgical treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHU

Amiens, 80054, France

Location

CHU

Besançon, 25030, France

Location

CHU

Bordeaux, 33075, France

Location

CHU

Bordeaux, 33604, France

Location

CHU

Caen, 14033, France

Location

CHU

Grenoble, 38043, France

Location

CHU

Lille, 59037, France

Location

CHU

Limoges, 87000, France

Location

CHU

Marseille, 13005, France

Location

Centre Hospitalier

Mulhouse, 68100, France

Location

CHU

Nancy, 54511, France

Location

CHU

Nantes, 44035, France

Location

HEGP

Paris, 75908, France

Location

Chu Reims

Reims, 51092, France

Location

Chu Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Bernard PIGNON

    CHU REIMS FRANCE

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 19, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

FR(15)