Clinical Research Directory
Browse clinical research sites, groups, and studies.
Safety and Preliminary Efficacy of hUCMSC-EVs in Interstitial Lung Disease
Sponsor: Shanghai Zhongshan Hospital
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
Conditions
Interventions
Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs)
hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles
Normal Saline Placebo
Nebulized inhalation BID × 7d per cycle, 3 cycles
Locations (1)
Zhongshan Hospital, Fudan University
Shanghai, China