Cell Therapy With Bone Marrow Mononuclear Cells in CLI - Full Text View

Sponsors and Collaborators:	University of Paris 5 - Rene Descartes AP-HP
Information provided by:	University of Paris 5 - Rene Descartes
ClinicalTrials.gov Identifier:	NCT00377897

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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
Healing
Amputation rate

Secondary Outcome Measures:

TcPO2

Estimated Enrollment:	20
Study Start Date:	January 2005
Estimated Study Completion Date:	September 2006

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 arounf 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 be 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 ti include patients in January 2005 and will last until decembre 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 gangrena
No possibility of surgical revascularization
No posibility 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

Study ID Numbers:	OPTIPEC
Study First Received:	September 18, 2006
Last Updated:	September 18, 2006
ClinicalTrials.gov Identifier:	NCT00377897
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University of Paris 5 - Rene Descartes:

critical leg ischemia
PAD
cell therapy

Study placed in the following topic categories:

Atherosclerosis
Ischemia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009