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.
Age 18 years and older, regardless of gender.
Diagnosed with interstitial lung disease (ILD).
High-resolution computed tomography (HRCT) findings within 3 months prior to randomization must be consistent with interstitial pulmonary imaging changes.
Pulmonary function test within the protocol-defined acceptable range prior to randomization.
Inability to tolerate nebulized inhalation therapy.
Requirement for oxygen supplementation > 15 hours per day during the screening period.
Allergic diathesis or a history of life-threatening drug hypersensitivity.
History of malignancy within 5 years.