NCT00377897

Brief Summary

This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 16, 2009

Status Verified

February 1, 2009

Enrollment Period

3.7 years

First QC Date

September 18, 2006

Last Update Submit

February 13, 2009

Conditions

Critical Leg Ischemia

Keywords

critical leg ischemiaPADcell therapy

Outcome Measures

Primary Outcomes (3)

  • Ankle brachial index

    6 months

  • Healing

    1 year

  • Amputation rate

    1 year

Secondary Outcomes (1)

  • TcPO2

    6 months

Interventions

cell therapyPROCEDURE

Injection of Bone-Marrow mononuclear cells in the muscles of the calf.

Eligibility Criteria

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

You may qualify if:

  • Age \> 18
  • Signature of informed consent
  • Critical leg ischemia with ankle pressure \< 70 mmHg
  • Ischemic ulcer or gangrene
  • No possibility of surgical revascularization
  • No possibility of angioplasty

You may not qualify if:

  • Cancer
  • Suspicion of a cancer on X-Ray, mammography or elevated PSA
  • Age \< 18
  • Life expectancy \< 6 months
  • Active retinopathy
  • Angioplasty or surgical revascularization within 3 months
  • Stoke within 3 months
  • HIV + or HCV/HBC+

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emmerich

Paris, Paris, 75015, France

RECRUITING

Related Publications (4)

  • HoWangYin KY, Loinard C, Bakker W, Guerin CL, Vilar J, d'Audigier C, Mauge L, Bruneval P, Emmerich J, Levy BI, Pouyssegur J, Smadja DM, Silvestre JS. HIF-prolyl hydroxylase 2 inhibition enhances the efficiency of mesenchymal stem cell-based therapies for the treatment of critical limb ischemia. Stem Cells. 2014 Jan;32(1):231-43. doi: 10.1002/stem.1540.

    PMID: 24105925DERIVED

  • Smadja DM, Duong-van-Huyen JP, Dal Cortivo L, Blanchard A, Bruneval P, Emmerich J, Gaussem P. Early endothelial progenitor cells in bone marrow are a biomarker of cell therapy success in patients with critical limb ischemia. Cytotherapy. 2012 Feb;14(2):232-9. doi: 10.3109/14653249.2011.627917. Epub 2011 Oct 31.

    PMID: 22040109DERIVED

  • Smadja DM, d'Audigier C, Guerin CL, Mauge L, Dizier B, Silvestre JS, Dal Cortivo L, Gaussem P, Emmerich J. Angiogenic potential of BM MSCs derived from patients with critical leg ischemia. Bone Marrow Transplant. 2012 Jul;47(7):997-1000. doi: 10.1038/bmt.2011.196. Epub 2011 Oct 10. No abstract available.

    PMID: 21986637DERIVED

  • Smadja DM, d'Audigier C, Bieche I, Evrard S, Mauge L, Dias JV, Labreuche J, Laurendeau I, Marsac B, Dizier B, Wagner-Ballon O, Boisson-Vidal C, Morandi V, Duong-Van-Huyen JP, Bruneval P, Dignat-George F, Emmerich J, Gaussem P. Thrombospondin-1 is a plasmatic marker of peripheral arterial disease that modulates endothelial progenitor cell angiogenic properties. Arterioscler Thromb Vasc Biol. 2011 Mar;31(3):551-9. doi: 10.1161/ATVBAHA.110.220624. Epub 2010 Dec 9.

    PMID: 21148423DERIVED

MeSH Terms

Interventions

Cell- and Tissue-Based Therapy

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Joseph Emmerich

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Emmerich, MD, PhD

CONTACT

33 1 56 09 30 51joseph.emmerich@egp.aphp.fr

Saliha Djane, MD

CONTACT

33 1 44 84 17 45saliha.djane@sls.aphp.fr

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 18, 2006

First Posted

September 19, 2006

Study Start

January 1, 2005

Primary Completion

September 1, 2008

Study Completion

December 1, 2009

Last Updated

February 16, 2009

Record last verified: 2009-02

Locations

FR(1)