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
|Condition or disease||Intervention/treatment||Phase|
|Critical Leg Ischemia||Procedure: cell therapy||Phase 1|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Procedure: cell therapy
Injection of Bone-Marrow mononuclear cells in the muscles of the calf.
- Ankle brachial index [ Time Frame: 6 months ]
- Healing [ Time Frame: 1 year ]
- Amputation rate [ Time Frame: 1 year ]
- TcPO2 [ Time Frame: 6 months ]
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
|Contact: Joseph Emmerich, MD, PhD||33 1 56 09 30 firstname.lastname@example.org|
|Contact: Saliha Djane, MD||33 1 44 84 17 email@example.com|
|Paris, France, 75015|
|Principal Investigator:||Joseph Emmerich||Assistance Publique - Hôpitaux de Paris|