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
| Registry | NCT07570836 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 1 |
| Study type | Interventional; randomized, sequential, masking: single, treatment |
| Enrollment | 24 (Estimated) |
| Sponsor | Shanghai Zhongshan Hospital (Other) |
| Conditions | Interstitial Lung Disease (ILD) |
| Interventions | Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs), Normal Saline Placebo (Biological) |
| Dates | start 2026-04-30 (estimated), primary completion 2027-04-30 (estimated), completion 2028-09-30 (estimated), first posted 2026-05-06, last updated 2026-05-06 |
| Locations | 1 site in China |
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All trials for Interstitial Lung Disease (ILD) All trials of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs) All trials of Normal Saline Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Low-dose group | Experimental | Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs); Biological: Normal Saline Placebo | |
| Moderate-dose group | Experimental | Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs); Biological: Normal Saline Placebo | |
| High-dose group | Experimental | Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs); Biological: Normal Saline Placebo |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | China |