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Clinical Trials associated with Human cord derived MSC cell(Allcare Biomedical)人脐带间充质干细胞注射液用于中、重度溃疡性结肠炎患者的I期临床试验
[Translation] Phase I clinical trial of human umbilical cord mesenchymal stem cell injection for 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、重度溃疡性结肠炎单次、多次给药的安全性、耐受性,探索其最大耐受剂量(MTD)和剂量限制毒性(DLT),为II期临床试验设计提供根据;次要目的:初步评价人脐带间充质干细胞注射液治疗中、重度溃疡性结肠炎的有效性;探索人脐带间充质干细胞注射液的药代动力学(PK)特征和免疫原性;探索人脐带间充质干细胞注射液治疗中、重度溃疡性结肠炎的药效动力学特征。
[Translation] The main purpose is to evaluate the safety and tolerability of single and multiple doses of human umbilical cord mesenchymal stem cell injection in the treatment of moderate to severe ulcerative colitis, explore its maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), and provide a basis for the design of a phase II clinical trial; the secondary purpose is to preliminarily evaluate the effectiveness of human umbilical cord mesenchymal stem cell injection in the treatment of moderate to severe ulcerative colitis; explore the pharmacokinetic (PK) characteristics and immunogenicity of human umbilical cord mesenchymal stem cell injection; explore the pharmacodynamic characteristics of human umbilical cord mesenchymal stem cell injection in the treatment of moderate to severe ulcerative colitis.
100 Clinical Results associated with Human cord derived MSC cell(Allcare Biomedical)
100 Translational Medicine associated with Human cord derived MSC cell(Allcare Biomedical)
100 Patents (Medical) associated with Human cord derived MSC cell(Allcare Biomedical)
100 Deals associated with Human cord derived MSC cell(Allcare Biomedical)