Bone Marrow Autograft in Limb Ischemia

Peripheral Vascular Diseases Clinical Trial

— BALI  

Official title:

Cell Therapy in Critical Limb Ischemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904501
• Other study ID #: PHRC2007- N11-02
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2009
• Last updated: March 5, 2016
• Start date: March 2009
• Est. completion date: January 2015

Study information

• Verified date: March 2016
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Procedure:
• Bone marrow harvest
Implantation of placebo
• Bone marrow harvest
Implantation of bone marrow - mononuclear cells

Locations

Country	Name	City	State
France	CHU	Amiens
France	CHU	Besancon
France	CHU	Bordeaux
France	CHU	Bordeaux
France	CHU	Caen
France	CHU	Grenoble
France	CHU	Lille
France	CHU	Limoges
France	CHU	Marseille
France	Centre Hospitalier	Mulhouse
France	CHU	Nancy
France	CHU	Nantes
France	HEGP	Paris
France	Chu Reims	Reims
France	Chu Strasbourg	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Reims	Etablissement Français du Sang

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major amputation rate and mortality		6 months	No
Secondary	Clinical symptoms and haemodynamical parameters		6 months	No