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NOT YET RECRUITING
NCT07570836
PHASE1

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

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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.

Official title: A Clinical Study to Explore the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles in the Treatment of Interstitial Lung Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-04-30

Completion Date

2028-09-30

Last Updated

2026-05-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs)

hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles

BIOLOGICAL

Normal Saline Placebo

Nebulized inhalation BID × 7d per cycle, 3 cycles

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, China