Status:
UNKNOWN
Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)
Lead Sponsor:
University of Paris 5 - Rene Descartes
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Conditions:
Critical Leg Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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-Yuy...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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+
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00377897
Start Date
January 1 2005
End Date
December 1 2009
Last Update
February 16 2009
Active Locations (1)
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1
Emmerich
Paris, Paris, France, 75015