At a glance
ClinicalIndex Comparison Record- ✓Age 40-75 years old
- ✓Diagnosed with IPF per 2022 ATS/ERS/JRS/ALAT guideline
- ✓Stable disease with DLCO 30-79% predicted, FVC ≥50% predicted, FEV1/FVC ≥0.70
- ✓Treated with standard IPF treatment for at least 3 months
- ✕Allergic to any ingredient of the product
- ✕Other interstitial lung diseases besides IPF
- ✕Active lung diseases including asthma, pulmonary embolism, pneumothorax, lung cancer, obstructive bronchitis
- ✕Immune system diseases or immunodeficiency diseases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06230822Phase 1RecruitingUpdate OverdueUpdated 28mo ago · Completion was 17mo agoA Phase I Open Label, Dose Escalation Study to Characterize the Safety, Tolerability, and Efficacy of VUM02 Injection in Subjects With Idiopathic Pulmonary Fibrosis
In Brief
A Phase 1 clinical trial evaluating VUM02 Injection for Idiopathic Pulmonary Fibrosis. Currently recruiting, targeting 9 participants across 4 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
VUM02 Injection will be administered intravenously every 3 days for a total of 3 doses.