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Clinical Trials associated with VUM-02A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of VUM02 Injection in the Treatment of Patients With Steroid-refractory Acute Graft-versus-host Disease (SR-aGvHD)
It is a phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of VUM02 Injection in patients with acute graft-versus-host disease (aGvHD) who have failed systemic steroid therapy. VUM02 Injection (human umbilical cord-derived mesenchymal stromal /stem cells, hUC-MSC) is an off-the-shelf allogeneic cell therapy product comprising culture-expanded mesenchymal stromal /stem cells derived from the human umbilical cord tissue. The product is cryopreserved with the cell concentration of 5 x 10^6 cells/mL. Patients with grade II to IV aGvHD who have failed systemic steroid therapy (i.e. patients with steroid-refractory aGvHD (SR-aGvHD)), will be recruited into this study. This study consists of two phases, a dose-escalation phase (phase I) and a dose-expansion phase (phase II).
探索VUM02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 VUM02 injection in the treatment of idiopathic pulmonary fibrosis (IPF)
主要研究目的:
评价不同剂量的VUM02注射液治疗特发性肺纤维化(IPF)的安全性、耐受性。
次要研究目的:
1)评价不同剂量的VUM02注射液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。
2)探索VUM02注射液治疗特发性肺纤维化(IPF)的免疫相关特征。
[Translation] Main research objectives:
Evaluate the safety and tolerability of different doses of VUM02 injection in the treatment of idiopathic pulmonary fibrosis (IPF).
Secondary research objectives:
1) Evaluate the preliminary effectiveness of different doses of VUM02 injection in the treatment of idiopathic pulmonary fibrosis (IPF) and recommend appropriate cell therapy doses for subsequent clinical studies.
2) Explore the immune-related characteristics of VUM02 injection in the treatment of idiopathic pulmonary fibrosis (IPF).
A Phase I Open Label, Dose Escalation Study to Characterize the Safety, Tolerability, and Efficacy of VUM02 Injection in Subjects With Idiopathic Pulmonary Fibrosis
This study is a single-arm, multiple-dose, dose-escalation, open-label multicenter clinical trial, aiming to evaluate the safety, tolerability, and preliminary efficacy of VUM02 Injection for treatment of idiopathic pulmonary fibrosis (IPF). VUM02 Injection (Human Umbilical Cord Tissue-derived Mesenchymal Stem Cells Injection, hUCT-MSC) is an allogeneic cell therapy product comprising culture-expanded Mesenchymal Stem Cells derived from the human umbilical cord tissue. The product is cryopreserved with the amount of 5 x 10^7 cells per 10 mL per bag (5 x 10^6 cells/mL). This study is a multiple-dose tolerability study following the "3+3" dose escalation principle and progressing from the low-dose group to the high-dose group sequentially. Three to six patients will be enrolled in each dose group and administered every 3 days for a total of 3 doses.
100 Clinical Results associated with VUM-02
100 Translational Medicine associated with VUM-02
100 Patents (Medical) associated with VUM-02
100 Deals associated with VUM-02