Clinical Trial

Safety and Preliminary Efficacy of hUCMSC-EVs in Interstitial Lung Disease

Not Yet Recruiting Phase 1
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Summary
This is an exploratory, randomized, single-blind, placebo-controlled, multiple-dose, dose-escalation clinical study. The study aims to evaluate the safety and preliminary efficacy of nebulized inhalation of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs) in patients with interstitial lung disease (ILD). This study is designed to include three sequential dose cohorts-low, medium, and high-with dose escalation proceeding in an ascending order. Eligible subjects will be enrolled and randomized sequentially, with a planned enrollment of 8 subjects per cohort. Within each cohort, subjects will be randomly assigned in a 3:1 ratio to receive either hUCMSC-EVs or saline placebo.
Trial Details
NCT Number NCT07570836
Lead Sponsor Shanghai Zhongshan Hospital
Conditions Interstitial Lung Disease (ILD)
Enrollment 24 participants
Start Date 2026-04-30
Primary Completion 2027-04-30 (estimated)
Study Completion 2028-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-06