Could stem cell 'Bubbles' ease breathing in lung scarring?
NCT ID NCT07570836
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether inhaling tiny particles from stem cells (called extracellular vesicles) is safe and might help people with interstitial lung disease, a condition that scars the lungs and makes breathing hard. About 24 adults will receive either the treatment or a saltwater placebo by nebulizer. The main goal is to check for side effects, not to cure the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongshan Hospital, Fudan University
Shanghai, China
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