Target- |
MechanismStem cell replacements |
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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Mechanism- |
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Inactive Indication- |
Drug Highest PhaseDiscovery |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ 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.
/ Not yet recruitingPhase 1 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、耐受性及初步有效性的开放性临床研究
[Translation] An open clinical study to explore the safety, tolerability and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD)
主要目的:
探索人脐带间充质干细胞注射液治疗间质性肺疾病(ILD)的安全性和耐受性;
次要目的:
探索人脐带间充质干细胞治疗间质性肺疾病(ILD)的初步有效性,为后续临床研究推荐合适的细胞治疗剂量;
探索人脐带间充质干细胞注射液治疗间质性肺疾病(ILD)的免疫原性。
[Translation] Main purpose:
To explore the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD);
Secondary purpose:
To explore the preliminary effectiveness of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD) and recommend appropriate cell therapy doses for subsequent clinical studies;
To explore the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD).
探索人脐带间充质干细胞注射液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 clinical study to explore the safety, tolerability and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in the treatment of idiopathic pulmonary fibrosis (IPF)
主要目的
-探索人脐带间充质干细胞治疗特发性肺纤维化(IPF)的安全性和耐受性。
次要目的
-探索人脐带间充质干细胞治疗特发性肺纤维化(IPF)的初步有效性,为后续临床研究推荐合适的细胞治疗剂量。
-探索人脐带间充质干细胞注射液治疗特发性肺纤维化(IPF)的免疫原性。
[Translation] Primary objective
- To explore the safety and tolerability of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF).
Secondary objective
- To explore the preliminary effectiveness of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF) and recommend appropriate cell therapy doses for subsequent clinical studies.
- To explore the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of idiopathic pulmonary fibrosis (IPF).
100 Clinical Results associated with Shanghai Laifu Medical Technology Co., Ltd.
0 Patents (Medical) associated with Shanghai Laifu Medical Technology Co., Ltd.
100 Deals associated with Shanghai Laifu Medical Technology Co., Ltd.
100 Translational Medicine associated with Shanghai Laifu Medical Technology Co., Ltd.