The purpose of this study is to evaluate the safety and efficacy of human TH-SC01 cell injection for the treatment of complex perianal fistulas
This study is a phase Ⅰ/Ⅱ study, Phase 1 was the dose increment phase, and phase 2 was the expansion phase
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Single injection of 0.6×10\^7,1.2×10\^8, 1.8×10\^8 cells/kg
saline solution will be given at the same quantity and following the same schedule
Xiangya Hospital Central University
Changsha, Hunan, China
Severity and incidence of study drug-related adverse-events
Severity and incidence of study drug-related adverse-events within D28(W4) after administration.
Time frame: Day 28 (Week 4)
Dose-limiting toxicity (DLT)
Exploration of dose-limiting toxicity (DLT)
Time frame: Day 28
maximum tolerated dose (MTD)
Exploration of maximum tolerated dose(MTD)
Time frame: Day 28
Percentage of effectiveness
Percentage of effectiveness at 84 days of administration by MRI imaging evaluated fistula healing with no or minimal effusion
Time frame: Day 84
Severity and incidence of study drug-related adverse-events
Severity and incidence of study drug-related adverse-events after D28(W4) after administration.
Time frame: Day 28
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