[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical study on the efficacy and safety of human umbilical cord mesenchymal stem cell injection in the treatment of patients with moderate to severe ulcerative colitis
主要目的:评价人脐带间充质干细胞注射液治疗中重度活动性UC的有效性;
次要目的:评价人脐带间充质干细胞注射液治疗中重度活动性UC的安全性;
探索性目的:探索人脐带间充质干细胞注射液在中重度活动性UC受试者中的药效学特征(仅第1阶段); 探索人脐带间充质干细胞注射液治疗前后UC生物标志物(如粪便钙卫蛋白和CRP)的变化。
[Translation] Primary purpose: To evaluate the efficacy of human umbilical cord mesenchymal stem cell injection in the treatment of moderately to severely active UC;
Secondary purpose: To evaluate the safety of human umbilical cord mesenchymal stem cell injection in the treatment of moderately to severely active UC;
Exploratory purpose: To explore the pharmacodynamic characteristics of human umbilical cord mesenchymal stem cell injection in subjects with moderately to severely active UC (Phase 1 only); To explore the changes in UC biomarkers (such as fecal calprotectin and CRP) before and after treatment with human umbilical cord mesenchymal stem cell injection.