Peripheral Arterial Disease Clinical Trial
Official title:
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty: A Randomized Controlled Clinical Trial in Diabetic Patients With Below the Knee Critical Limb Ischemia
The main aim of the present study was to evaluate the therapeutic potential and safety of transarterial infusion of granulocyte colony stimulating factor (G-CSF) mobilized cluster of differentiation (CD) 133(+) cells when combined with percutaneous transluminal angioplasty (PTA) in treatment of below the knee (BTK) peripheral arterial disease (PAD) in diabetic patients.
CD133+ cell, a bone marrow derived subpopulation of adult hematopoietic progenitor cells,
confers high proliferative, vasculogenic and regenerative capacity in vitro and in vivo.
thereby suggesting that CD133+ cells may induce vasculogenesis, improve limb perfusion,
prevent tissue loss and restore ambulatory function in patients with critical limb ischemia.
Although several small, randomized trials have been conducted so far demonstrating safety of
autologous cells of bone marrow origin for the treatment, the reported benefits were found
to be variable. A meta-analysis of autologous bone marrow derived cell therapy for critical
limb ischemia trials suggested that application of autologous stem cell transplantation in
curing limb ischemic patients does not have obviously effectiveness in the improvement of
ankle brachial pressure (ABI) of the limb ischemic patients. But it can dramatically reduce
the rate of amputation.
Therefore, in the present study, the investigators aim to evaluate the therapeutic potential
and safety of transarterial infusion of g-csf-mobilized CD 133(+) cells when combined with
PTA in treatment of below the knee PAD in diabetic patients.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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