[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial evaluating the efficacy and safety of human TH-SC01 cell injection in the treatment of inactive/mildly active Crohn's disease anal fistula
主要目的:评价TH-SC01细胞注射液治疗非活动性/轻度活动性克罗恩病肛瘘的有效性。
次要目的:评价TH-SC01细胞注射液治疗非活动性/轻度活动性克罗恩病肛瘘的安全性。
探索性目的:评价TH-SC01细胞注射液治疗非活动性/轻度活动性克罗恩病肛瘘的长期有效性和安全性。
[Translation] Main purpose: To evaluate the effectiveness of TH-SC01 cell injection in the treatment of inactive/mildly active Crohn's disease anal fistula.
Secondary objective: To evaluate the safety of TH-SC01 cell injection in the treatment of inactive/mildly active Crohn's disease anal fistula.
Exploratory purpose: To evaluate the long-term efficacy and safety of TH-SC01 cell injection in the treatment of inactive/mildly active Crohn's disease anal fistula.