3
项与 人脐带间充质干细胞 (拓华生物) 相关的临床试验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、耐受性和初步有效性的Ⅰ/Ⅱ期临床研究
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)。
A Phase I-II, Open-label, Single-arm, Dose-escalation Clinical Trial to Evaluate the Safety and Tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Moderate to Severe Acute Respiratory Distress Syndrome
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 Objectives: To explore the efficacy and appropriate dosage 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 pharmacokinetic/pharmacodynamic (PK/PD) characteristics of a single dose of human umbilical cord mesenchymal stem cell injection in patients with moderate/severe acute respiratory distress syndrome.
A Phase I-II Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in Patients With Decompensated Hepatitis B Cirrhosis
Phase I (Single Administration, Randomized, Double-blind, Dose Escalation)Primary Objective: To evaluate the safety and tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis, and to determine the safe clinical dose.Secondary Objective: To evaluate the preliminary efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis, providing a basis for the design of subsequent clinical trial protocols.Exploratory Objective: To evaluate the pharmacokinetic characteristics and immunogenicity of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Phase II (Multiple Administrations, Randomized, Double-blind, Dose Expansion)Primary Objective: To evaluate the preliminary efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Secondary Objective: To evaluate the safety of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Exploratory Objective: To evaluate the pharmacokinetic characteristics and immunogenicity of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.
100 项与 人脐带间充质干细胞 (拓华生物) 相关的临床结果
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100 项与 人脐带间充质干细胞 (拓华生物) 相关的专利(医药)
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