Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)
Recruitment status was: Recruiting
|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|
- 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 ]
- TcPO2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|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)|
Procedure: cell therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377897
|Paris, France, 75015|
|Principal Investigator:||Joseph Emmerich||Assistance Publique - Hôpitaux de Paris|