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Could stem cell 'Bubbles' ease breathing in lung scarring?

NCT ID NCT07570836

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Zhongshan Hospital, Fudan University

    Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.