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Not yet recruiting NCT07570836

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

Phase I Interventional Interstitial Lung Disease (ILD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs), Normal Saline Placebo.
Who it may be relevant to
Registry conditions: Interstitial Lung Disease (ILD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence and Severity of Adverse Events [Time frame: From first dose to Week 12]
Secondary outcome measures (4)
  • Change from Baseline in Forced Vital Capacity (FVC) [Time frame: From first dose to Week 24]
  • Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [Time frame: From first dose to Week 24]
  • Change from Baseline in 6-Minute Walk Test (6MWT) Distance [Time frame: From first dose to Week 24]
  • Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score [Time frame: From first dose to Week 24]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT07570836 · ACE001-RI001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗