Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Paris 5 - Rene Descartes.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AP-HP
Information provided by:
University of Paris 5 - Rene Descartes
ClinicalTrials.gov Identifier:
NCT00377897
First received: September 18, 2006
Last updated: February 13, 2009
Last verified: February 2009
  Purpose

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).


Condition Intervention Phase
Critical Leg Ischemia
Procedure: cell therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose

Further study details as provided by University of Paris 5 - Rene Descartes:

Primary Outcome Measures:
  • Ankle brachial index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Healing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Amputation rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TcPO2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: cell therapy
    Injection of Bone-Marrow mononuclear cells in the muscles of the calf.
Detailed Description:

Patients will be included with CLI according to the TASC criteria. Under general anesthesia, 500 ml of bone marrow is harvested in both iliac crests. After isolation and concentration of the BMMNC in 30 ml, 40 injections of around 0.75 ml will be done in the gastrocnemius of the ischemic leg, within 3 hours after preparation of the cell therapy product.

Patients will then be followed-up every week during one month and then every month during one year.

This study was approved by the ethical committee of Paris-Broussais HEGP (France) and our french regulatory agency (AFSSAPS).

It began including patients in January 2005 and will last until December 2007.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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+
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377897

Contacts
Contact: Joseph Emmerich, MD, PhD 33 1 56 09 30 51 joseph.emmerich@egp.aphp.fr
Contact: Saliha Djane, MD 33 1 44 84 17 45 saliha.djane@sls.aphp.fr

Locations
France
Emmerich Recruiting
Paris, France, 75015
Sponsors and Collaborators
University of Paris 5 - Rene Descartes
AP-HP
Investigators
Principal Investigator: Joseph Emmerich AP-HP
  More Information

No publications provided by University of Paris 5 - Rene Descartes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DRC, APHP
ClinicalTrials.gov Identifier: NCT00377897     History of Changes
Other Study ID Numbers: OPTIPEC
Study First Received: September 18, 2006
Last Updated: February 13, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University of Paris 5 - Rene Descartes:
critical leg ischemia
PAD
cell therapy

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014