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

NCT07570836 — Phase 1, Not yet recruiting, 24 participants, Shanghai Zhongshan Hospital

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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

RegistryNCT07570836
StatusNot yet recruiting
PhasePhase 1
Study typeInterventional; randomized, sequential, masking: single, treatment
Enrollment24 (Estimated)
SponsorShanghai Zhongshan Hospital (Other)
ConditionsInterstitial Lung Disease (ILD)
InterventionsHuman Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs), Normal Saline Placebo (Biological)
Datesstart 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
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
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

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Low-dose groupExperimentalBiological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs); Biological: Normal Saline Placebo
Moderate-dose groupExperimentalBiological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs); Biological: Normal Saline Placebo
High-dose groupExperimentalBiological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs); Biological: Normal Saline Placebo
  • Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs) (Biological): hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles
  • Normal Saline Placebo (Biological): Nebulized inhalation BID × 7d per cycle, 3 cycles

+Outcome measures

Primary outcomes

  • Incidence and Severity of Adverse Events [From first dose to Week 12]

Secondary outcomes

  • Change from Baseline in Forced Vital Capacity (FVC) [From first dose to Week 24]: Forced Vital Capacity (FVC) will be assessed using standardized spirometry in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Measurements will be performed at Baseline (prior to first dose) and at scheduled post-baseline visits. Spirometry will be conducted using a calibrated spirometer. Results will be summarized as absolute change from baseline and percent predicted normal values.
  • Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [From first dose to Week 24]: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) will be assessed using the single-breath method in accordance with ATS/ERS guidelines. Hemoglobin-corrected DLCO values will be recorded if applicable. Measurements will be performed at Baseline and at scheduled post-baseline visits. Results will be summarized as absolute change from baseline and percent predicted normal values.
  • Change from Baseline in 6-Minute Walk Test (6MWT) Distance [From first dose to Week 24]
  • Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score [From first dose to Week 24]: The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure health-related quality of life in patients with chronic respiratory diseases. The Total Score is calculated as a weighted sum of the domain scores and ranges from 0 to 100, with higher scores indicating worse health-related quality of life. A change of 4 units is generally considered the minimal clinically important difference (MCID).

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Zhongshan Hospital, Fudan UniversityShanghaiChina