The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with critical limb ischemia
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 \~3x10e8 cells
Pusan National University Hospital
Pusan, South Korea
Major Adverse Events Analysis (MAEs)
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs
Time frame: 48 weeks
Ankle-Brachial Index (ABI)
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Time frame: 48 weeks
Digital subtraction angiography (DSA)
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Time frame: 48 weeks
Thermography
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Time frame: 48 weeks
Wong-Baker FACES Pain Rating Score
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Time frame: 48 weeks
Treadmill test
To evaluate the change of treated critical limb ischemia before cell implantation and at 3, 6, 12 months post injection of MSCs.
Time frame: 48 weeks
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