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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00377897
Recruitment Status : Unknown
Verified February 2009 by University of Paris 5 - Rene Descartes.
Recruitment status was:  Recruiting
First Posted : September 19, 2006
Last Update Posted : February 16, 2009
Assistance Publique - Hôpitaux de Paris
Information provided by:
University of Paris 5 - Rene Descartes

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).

Condition or disease Intervention/treatment Phase
Critical Leg Ischemia Procedure: cell therapy Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2005
Estimated Primary Completion Date : September 2008
Estimated Study Completion Date : December 2009

Intervention Details:
    Procedure: cell therapy
    Injection of Bone-Marrow mononuclear cells in the muscles of the calf.

Primary Outcome Measures :
  1. Ankle brachial index [ Time Frame: 6 months ]
  2. Healing [ Time Frame: 1 year ]
  3. Amputation rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. TcPO2 [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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+

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00377897

Contact: Joseph Emmerich, MD, PhD 33 1 56 09 30 51
Contact: Saliha Djane, MD 33 1 44 84 17 45

Emmerich Recruiting
Paris, France, 75015
Sponsors and Collaborators
University of Paris 5 - Rene Descartes
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Joseph Emmerich Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: DRC, APHP Identifier: NCT00377897     History of Changes
Other Study ID Numbers: OPTIPEC
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: February 16, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Pathologic Processes