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

History of Changes

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:

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):

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. Epub 2011 Oct 31.

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.

Smadja DM, d'Audigier C, Bièche 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. Epub 2010 Dec 9.

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 May 19, 2013

To Top