Status:
COMPLETED
Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
Lead Sponsor:
Andalusian Network for Design and Translation of Advanced Therapies
Collaborating Sponsors:
Carlos III Health Institute
Conditions:
Peripheral Vascular Diseases
Diabetic Foot
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revasculariz...
Detailed Description
Phase I/II, prospective, single-center study, with consecutive inclusion of 20 diabetic patients with critical limb ischemia due to bellow-the-knee extensive arterial disease. After the inclusion, pa...
Eligibility Criteria
Inclusion
- Diabetic patients under treatment (type I or II)
- Critical limb ischemia (rest pain and/or non-healing ischemic ulcers lasting more than 4 weeks, and/or Ankle-Brachial Index \< 0,8)
- Not suitable to be revascularized (surgical and interventional consensus)
Exclusion
- Neoplastic disease and/or hematologic disease during the last 2 years
- Diabetic retinopathy
- Ischemic ulcer greater than 10 cm2
- Major amputation at target limb
- Life expectancy \> 2 years
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00872326
Start Date
December 1 2007
End Date
May 1 2009
Last Update
November 14 2014
Active Locations (1)
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1
University Hospital Virgen Macarena
Seville, Seville, Spain, 41007