Target- |
MechanismStem cell replacements |
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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
人脐带间充质干细胞注射液治疗中/重度急性呼吸窘迫综合征的安全性和耐受性开放、单臂、剂量递增Ⅰ-Ⅱ期临床试验
[Translation] An open, single-arm, dose-escalation phase I-II clinical trial of the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome
主要目的:评估人脐带间充质干细胞注射液治疗中/重度急性呼吸窘迫综合征的安全性及耐受性。
次要目的:探索人脐带间充质干细胞注射液治疗中/重度急性呼吸窘迫综合征的有效性和适宜剂量。
探索性目的:探索人脐带间充质干细胞注射液单次给药在中、重度急性呼吸窘迫综合征患者的免疫原性及PK/PD特征。
[Translation] Primary objective: To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.
Secondary objective: To explore the efficacy and appropriate dose of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.
Exploratory objective: To explore the immunogenicity and PK/PD characteristics of a single dose of human umbilical cord mesenchymal stem cell injection in patients with moderate and severe acute respiratory distress syndrome.
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