Normal Saline Placebo: Nebulized inhalation BID × 7d per cycle, 3 cycles
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
* 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.
* Good compliance, able to understand and cooperate with the required examinations and procedures, and willing to attend follow-up visits as scheduled.
* Voluntary participation and signing of written informed consent form.
Key Exclusion Criteria:
* 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.
* Active hepatitis B, hepatitis C, or HIV infection.
* Active systemic infection requiring antibiotic therapy.
* Clinically significant laboratory abnormalities at screening.
* Concomitant significant or severe respiratory disease.
* History of psychiatric illness, epilepsy, or other central nervous system disorders.
* Concomitant severe cardiovascular, hepatic, or renal systemic disease.
* Pregnancy, planned pregnancy in the near future, or breastfeeding.
* Unwillingness to use effective contraception during the study period.
* Any condition that, in the opinion of the investigator, may increase the risk to the participant or interfere with the study outcomes.
Primary outcome measure(s)
Incidence and Severity of Adverse Events — From first dose to Week 12
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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