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MechanismStem cell replacements |
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Drug Highest PhasePhase 1/2 |
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Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
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Drug Highest PhaseDiscovery |
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/ Not yet recruitingPhase 1 An Open Clinical Study Exploring the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Interstitial Lung Disease (ILD)
Main objective: To explore the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD); Secondary objective: To explore the preliminary effectiveness of human umbilical cord mesenchymal stem cell therapy for interstitial lung disease (ILD) and recommend appropriate cell therapy doses for subsequent clinical studies; Exploring the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD).
An Open Clinical Study to Explore the Safety, Tolerance and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Main purpose
-To explore the safety and tolerance of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF).
Secondary purpose
* To explore the preliminary efficacy of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF), and to recommend the appropriate dose of cell therapy for subsequent clinical studies.
* To explore the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of idiopathic pulmonary fibrosis (IPF).
This study adopts a clinical research design of multi center, single dose and increasing dose.
18 qualified IPF subjects will be included in this study.
/ Not yet recruitingPhase 1/2 探索人脐带间充质干细胞注射液治疗间质性肺病(ILD)的安全性、耐受性和初步有效性的I/II期临床试验
[Translation] A Phase I/II clinical trial to explore the safety, tolerability and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD)
I期主要目的:评价人脐带间充质干细胞注射液多次给药治疗ILD患者的安全性和耐受性,并确定最大耐受剂量(MTD)及II期推荐剂量(RP2D)。次要目的:评价人脐带间充质干细胞注射液多次给药治疗ILD患者的初步有效性和免疫原性。
II期的主要目的:评价人脐带间充质干细胞注射液治疗ILD患者的有效性。次要目的:评价人脐带间充质干细胞注射液治疗ILD患者的安全性和免疫原性。
[Translation] The main purpose of Phase I is to evaluate the safety and tolerability of multiple administrations of human umbilical cord mesenchymal stem cell injection in the treatment of ILD patients, and to determine the maximum tolerated dose (MTD) and Phase II recommended dose (RP2D). Secondary purpose: to evaluate the preliminary efficacy and immunogenicity of multiple administrations of human umbilical cord mesenchymal stem cell injection in the treatment of ILD patients.
The main purpose of Phase II is to evaluate the efficacy of human umbilical cord mesenchymal stem cell injection in the treatment of ILD patients. Secondary purpose: to evaluate the safety and immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of ILD patients.
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