一项评价REGEND001 细胞自体回输制剂移植治疗特发性肺纤维化患者有效性、安全性的多中心、随机、双盲、安慰剂平行对照II 期临床研究
[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of autologous retransfusion of REGEND001 cells in the treatment of patients with idiopathic pulmonary fibrosis
评价REGEND001 细胞自体回输制剂移植治疗特发性肺纤维化患者的有效性、安全性。
[Translation] To evaluate the efficacy and safety of autologous REGEND001 cell transplantation in the treatment of patients with idiopathic pulmonary fibrosis.
REGEND001细胞自体回输制剂移植治疗肺弥散功能障碍的慢性阻塞性肺疾病(COPD)的
探索性临床研究(多中心、随机、单盲、安慰剂平行对照)
[Translation] An exploratory clinical study of autologous retransfusion of REGEND001 cells for the treatment of chronic obstructive pulmonary disease (COPD) with pulmonary diffusion dysfunction (multicenter, randomized, single-blind, placebo-controlled)
评价REGEND001细胞自体回输制剂移植治疗肺弥散功能障碍的慢性阻塞性肺疾病(COPD)的有效性、安全性。
[Translation] To evaluate the efficacy and safety of autologous REGEND001 cell transplantation in the treatment of chronic obstructive pulmonary disease (COPD) with pulmonary diffusion dysfunction.
探索REGEND001细胞自体回输制剂移植治疗特发性肺纤维化(IPF)的安全性、耐受性及初步有效性的开放性临床研究
[Translation] An open-label clinical study to explore the safety, tolerability and preliminary efficacy of autologous retransfusion of REGEND001 cells in the treatment of idiopathic pulmonary fibrosis (IPF)
主要研究目的:评价不同剂量的REGEND001细胞自体回输制剂移植治疗特发性肺纤维化(IPF)的安全性、耐受性。
次要研究目的:评价不同剂量的REGEND001细胞自体回输制剂移植治疗特发性肺纤维化(IPF)的有效性,为后续临床研究推荐合适的细胞治疗剂量。
[Translation] The main purpose of the study is to evaluate the safety and tolerability of different doses of REGEND001 autologous cell infusion preparations for the treatment of idiopathic pulmonary fibrosis (IPF).
The secondary purpose of the study is to evaluate the effectiveness of different doses of REGEND001 autologous cell infusion preparations for the treatment of idiopathic pulmonary fibrosis (IPF) and recommend appropriate cell therapy doses for subsequent clinical studies.
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