The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound.
Critical limb ischemia (CLI) is a progressive disease, which arises as a result of atherosclerosis or vasculitis in leg arteries. Prognosis of CLI is poor, and no effective treatments have been established in patients who are not eligible for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the leg arteries or frequent reocclusion following revascularization. Therefore, it is necessary to establish novel revascularization treatment to improve prognosis of the no-option patients. The investigators will study the safety and clinical efficiency of vascular regeneration by means of transplantation of allogeneic Endothelial Progenitor Cells in patients with CLI who are not eligible for traditional revascularization treatments. The primary endpoint is the safety and tolerance identified by adverse events related with investigated drug;while the secondary endpoints are evaluation of the preliminary efficacy of EPCs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
IV
Clinical standard treatment
Hui Shi
Beijing, Beijing Municipality, China
RECRUITINGadverse events
Incidence and severity of adverse events assessed by CTCAE V5.0
Time frame: baseline to 1 year
Painless walking and intermittent claudication distance
Changes from the baseline of painless walking and intermittent claudication distance by visit
Time frame: month 6
Blood flow of the affected limb
Changes from the baseline of Blood flow of the affected limb by visit
Time frame: month 6
Rutherford grade
Changes from the baseline of Rutherford grade by visit. The range of Rutherford grade is from 0 (normal) to 6 (worse).
Time frame: month 6
The area of skin ulcer
Changes from the baseline of the area of skin ulcer by visit
Time frame: month 6
Vascular Quality of Life Questionnaire-6 score
Changes from the baseline of Vascular Quality of Life Questionnaire-6 score by visit. The range of scores is from 6 (normal) to 24.
Time frame: month 6
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