[Translation] A phase I/II clinical study to evaluate the safety, tolerability, and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with fibrotic interstitial lung disease
主要目的:
Ⅰ期:评价人脐带间充质干细胞注射液在纤维化性间质性肺病患者中单次给药(SAD)的安全性和耐受性。
Ⅱa期:评价人脐带间充质干细胞注射液在纤维化性间质性肺病患者中多次给药(MAD)的安全性和耐受性。
Ⅱb期:首次给药后24周,用力肺活量(FVC)较基线的变化。
次要目的:
评价人脐带间充质干细胞注射液在纤维化性间质性肺病患者中的有效性。
评价人脐带间充质干细胞注射液在纤维化性间质性肺病患者中的安全性(仅Ⅱb期)。
[Translation] Primary Objectives:
Phase I: To evaluate the safety and tolerability of a single dose (SAD) of human umbilical cord mesenchymal stem cell injection in patients with fibrotic interstitial lung disease.
Phase IIa: To evaluate the safety and tolerability of multiple doses (MAD) of human umbilical cord mesenchymal stem cell injection in patients with fibrotic interstitial lung disease.
Phase IIb: To evaluate the change from baseline in forced vital capacity (FVC) 24 weeks after the first dose.
Secondary Objectives:
To evaluate the efficacy of human umbilical cord mesenchymal stem cell injection in patients with fibrotic interstitial lung disease.
To evaluate the safety of human umbilical cord mesenchymal stem cell injection in patients with fibrotic interstitial lung disease (Phase IIb only).