The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb ischemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Survival without major amputation
Time frame: 6 months after implantation
Perfusion rate in treated tissue by measure of ankle-brachial index (ABI)
Time frame: Within 6 months after implantation
Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2)
Time frame: Within 6 months after implantation
Perfusion rate in treated tissue by digital subtraction angiography (DSA)
Time frame: Within 6 months after implantation
wound size
Time frame: Within 6 months after implantation
wound stage
Time frame: Within 6 months after implantation
Pain intensity
Pain intensity using Visual Analogue Scale
Time frame: Within 6 months after implantation
Thermography
Time frame: Within 6 months after implantation
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