Status:
COMPLETED
Autologous Bone Marrow Stem Cell Transfer in Patients With Chronical Critical Limb Ischemia and Diabetic Foot
Lead Sponsor:
University Hospital Ostrava
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A total of 90 patients suffering from end stage-IV Fontaine /CLI and diabetic foot with an ulcerated limb in whom all previous therapeutic strategies failed (e.g. surgical revascularization) will be s...
Detailed Description
1. INTRODUCTION: The local method of autologous bone marrow stem cells transplantation consists of harvesting bone marrow from the iliac crest, its separation using cell separator to generate ABMS...
Eligibility Criteria
Inclusion
- patients suffering from chronic and critical limb ischemia according to the TASC classification Rutherford 4-6, Fontaine IV,
- with failed basic conservative and revascularization treatment (surgical or endovascular),
- with age over 18 years,
- with signed informed consent for this procedure,
- without acute CLI that would require early limb amputation.
Exclusion
- patients with estimated survival less than 6 months,
- with known bone marrow diseases,
- with the final stage of renal failure and dialysed,
- with acute stage of severe limb ischemia with severe inflammatory process affecting patient's life which require limb amputation to avert deterioration in clinical condition and death.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01232673
Start Date
October 1 2008
End Date
December 1 2010
Last Update
March 22 2013
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.