Interstitial Lung Disease (ILD)Phase 1NCT07570836
Safety and Preliminary Efficacy of hUCMSC-EVs in Interstitial Lung Disease
A Phase 1 study testing Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs) in people with Interstitial Lung Disease (ILD), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease (ILD)
- What is being tested?
- Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 30 Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital, Fudan University
Shanghai
Tong, M.D, 86-13764089607, tong.lin@zs-hospital.sh.cn
Yuanlin Song, M.D
About this study
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
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.
- Conditions
- Interstitial Lung Disease (ILD)
- Being tested
- Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs), Normal Saline Placebo
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs)Biological
hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles
Normal Saline PlaceboBiological
Nebulized inhalation BID × 7d per cycle, 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | Not described Receives: Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs); Biological: Normal Saline Placebo |
| Moderate-dose group | Experimental | Not described Receives: Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs); Biological: Normal Saline Placebo |
| High-dose group | Experimental | Not described Receives: Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs); Biological: Normal Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events
Measured: From first dose to Week 12
Secondary outcomes (4)
Change from Baseline in Forced Vital Capacity (FVC)
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.
Measured: From first dose to Week 24
Change from Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
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.
Measured: From first dose to Week 24
Change from Baseline in 6-Minute Walk Test (6MWT) Distance
Measured: From first dose to Week 24
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score
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).
Measured: From first dose to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study is designed as a dose-escalation trial comprising three sequential dose cohorts: low-dose, medium-dose, and high-dose. Escalation will proceed from the lowest to the highest dose level. Within each cohort, subjects will be randomized in a 3:1 ratio to receive either investigational product or placebo.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570836
- Sponsor's protocol ID
- ACE001-RI001
- Status last verified
- May 2026
- First submitted
- 17 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07570836
- Acronym / sponsor ID
- ACE001-RI001
- Conditions
- Interstitial Lung Disease (ILD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study is designed as a dose-escalation trial comprising three sequential dose cohorts: low-dose, medium-dose, and high-dose. Escalation will proceed from the lowest to the highest dose level. Within each cohort, subjects will be randomized in a 3:1 ratio to receive either investigational product or placebo.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs)hUCMSC-EVs , nebulized BID × 7d/cycle, 3 cycles | Biological | High-dose group, Low-dose group, Moderate-dose group |
| Normal Saline PlaceboNebulized inhalation BID × 7d per cycle, 3 cycles | Biological | High-dose group, Low-dose group, Moderate-dose group |
Primary outcome
Incidence and Severity of Adverse Events
Time frame: From first dose to Week 12
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs) in people with Interstitial Lung Disease (ILD), run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tong, M.D (86-13764089607, tong.lin@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (time frame: From first dose to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.