Safety and Preliminary Efficacy of hUCMSC-EVs in Interstitial Lung Disease
Starting soon · Phase 1 · Has a placebo group
Conditions studied: Interstitial Lung Disease (ILD)
In brief
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.
Key facts
- Study ID
- NCT07570836
- Run by
- Shanghai Zhongshan Hospital
- People needed
- 24
- Starts
- 2026-04-30
- Expected to finish
- 2028-09-30
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Zhongshan Hospital, Fudan University — Shanghai, China
Full record on ClinicalTrials.gov
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