NCT00533104

Brief Summary

The primary focus of the trial is safety and efficacy of the intra-muscular implantation of either bone-marrow, or peripheral blood mononuclear cells, in critical limb ischemia, as judged by the proportion of patients which are alive without major amputation 6 months after inclusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

October 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

4.3 years

First QC Date

September 19, 2007

Last Update Submit

February 5, 2009

Conditions

Peripheral Vascular Diseases

Keywords

Limb ischemiaCell Therapy

Outcome Measures

Primary Outcomes (1)

  • Survival without major amputation

    6 months after implantation

Secondary Outcomes (1)

  • clinical symptoms and haemodynamic parameters

    Within 6 months after implantation

Study Arms (2)

BM-MNC

EXPERIMENTAL

Patients are implanted with bone marrow - mononuclear cells

Procedure: BM-MNC preparation

PB-MNC

EXPERIMENTAL

Patients are implanted with peripheral blood - mononuclear cells

Procedure: PB-MNC preparation

Interventions

BM-MNC preparationPROCEDURE

For autologous bone marrow - mononuclear cells preparation, 500ml of bone marrow are collected under general anaesthesia; mononuclear cells are separated using a blood-cells separator (COBE SPECTRA, GAMBRO BCT) and concentrated to produce a final volume of 40ml. Cells are implanted 1 to 3 hours after preparation by multiple intramuscular injections into the gastrocnemius of the ischemic leg.(30 injection sites, 1 to 1.5 cm deep, spaced 1 cm apart,1 ml per injection).

BM-MNC
PB-MNC preparationPROCEDURE

Peripheral blood - mononuclear cells are collected through cytapheresis with the same blood-cells separator which is adjusted to obtain a 40 mL cell product. No previous mobilization with hematopoïetic growth-factor is administered. Cells are implanted 1 to 3 hours after preparation by multiple intramuscular injections into the gastrocnemius of the ischemic leg.(30 injection sites, 1 to 1.5 cm deep, spaced 1 cm apart,1 ml per injection).

PB-MNC

Eligibility Criteria

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

You may qualify if:

  • Patients with unilateral critical chronic limb ischemia but not suitable candidates for non-surgical or surgical revascularization
  • Before being included, the patient must be screened for human immunodeficiency virus, hepatitis B virus, hepatitis C virus, treponema pallidum

You may not qualify if:

  • Buerger disease
  • Ischemic ulcers with infectious symptoms
  • Diabetes mellitus with HbA1c \> 7,5% or with proliferative retinopathy
  • Past or current malignancy
  • Contra-indication to general anaesthesia
  • Chronic haemodialysis
  • Prothrombin Time \< 60%,
  • Recent onset (within 3 months) of myocardial infarction or brain infarction
  • Coronary angioplasty within 1 year
  • Atrial fibrillation, mechanical mitral prosthetic valve
  • Unexplained hematological abnormality.
  • Expected life span less than six months
  • Patient not competent to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patricia LEMARCHAND

Nantes, 44000, France

Location

Related Publications (3)

  • Pignon B, Sevestre MA, Chatelain D, Albertini JN, Sevestre H. Histological changes after implantation of autologous bone marrow mononuclear cells for chronic critical limb ischemia. Bone Marrow Transplant. 2007 May;39(10):647-8. doi: 10.1038/sj.bmt.1705656. Epub 2007 Mar 26. No abstract available.

    PMID: 17384655RESULT

  • Al-Rifai R, Nguyen P, Bouland N, Terryn C, Kanagaratnam L, Poitevin G, Francois C, Boisson-Vidal C, Sevestre MA, Tournois C. In vivo efficacy of endothelial growth medium stimulated mesenchymal stem cells derived from patients with critical limb ischemia. J Transl Med. 2019 Aug 9;17(1):261. doi: 10.1186/s12967-019-2003-3.

    PMID: 31399109DERIVED

  • Capiod JC, Tournois C, Vitry F, Sevestre MA, Daliphard S, Reix T, Nguyen P, Lefrere JJ, Pignon B. Characterization and comparison of bone marrow and peripheral blood mononuclear cells used for cellular therapy in critical leg ischaemia: towards a new cellular product. Vox Sang. 2009 Apr;96(3):256-65. doi: 10.1111/j.1423-0410.2008.01138.x. Epub 2008 Dec 15.

    PMID: 19207166DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Bernard PIGNON, MD

    University Hospital REIMS FRANCE

    STUDY DIRECTOR

  • Marie-Antoinette SEVESTRE, MD

    University Hospital AMIENS FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 21, 2007

Study Start

October 1, 2004

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

FR(1)