Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377897
Status:
UNKNOWN
Last Update Posted:
2009-02-16
First Post:
2006-09-18
Brief Title:
Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia CLI
Sponsor:
University of Paris 5 - Rene Descartes
Organization:
University of Paris 5 - Rene Descartes
Study Overview
Official Title:
Optimisation dun Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans lischémie Critique Des Membres inférieurs liée à lathérosclérose
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 075 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None