评价脐带间充质干细胞注射液对类风湿关节炎患者的安全性、耐受性及初步有效性的随机、双盲、安慰剂对照、单次给药、剂量递增Ⅰ期临床研究
[Translation] A randomized, double-blind, placebo-controlled, single-dose, dose-escalation phase I clinical study evaluating the safety, tolerability, and preliminary efficacy of umbilical cord mesenchymal stem cell injection in patients with rheumatoid arthritis.
主要目的:评价脐带间充质干细胞注射液在类风湿关节炎患者中的单次给药后的安全性和耐受性。次要目的:评价脐带间充质干细胞注射液在类风湿关节炎患者中的初步有效性。
[Translation] Primary objective: To evaluate the safety and tolerability of a single-dose umbilical cord mesenchymal stem cell injection in patients with rheumatoid arthritis. Secondary objective: To evaluate the preliminary efficacy of the umbilical cord mesenchymal stem cell injection in patients with rheumatoid arthritis.
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