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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
University of Paris 5 - Rene Descartes

Study Description
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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 Design
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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
Arms and Interventions
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Intervention Details:
  • Procedure: cell therapy
    Injection of Bone-Marrow mononuclear cells in the muscles of the calf.

Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00377897


Contacts
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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
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France
Emmerich Recruiting
Paris, France, 75015
Sponsors and Collaborators
University of Paris 5 - Rene Descartes
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Joseph Emmerich Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: DRC, APHP
ClinicalTrials.gov Identifier: NCT00377897    
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
PAD
cell therapy
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes