[Translation] A phase I clinical study to evaluate the safety, tolerability and clinical efficacy of allogeneic adipose-derived mesenchymal stem cells (hADSCs) in the treatment of knee osteoarthritis
主要目的:
评价hADSCs治疗膝骨关节炎受试者的临床安全性和耐受性,为本品的后续研究推荐安全剂量范围及RP2D。
次要目的:
初步评价hADSCs治疗膝骨关节炎受试者的有效性,为后续临床试验方案设计提供依据。
[Translation] Main purpose:
Evaluate the clinical safety and tolerability of hADSCs in the treatment of subjects with knee osteoarthritis, and recommend a safe dose range and RP2D for subsequent studies of this product.
Secondary purpose:
Preliminary evaluation of the effectiveness of hADSCs in the treatment of subjects with knee osteoarthritis, and provide a basis for the design of subsequent clinical trial programs.