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Can stem cell mist heal lungs damaged by cancer immunotherapy?

NCT ID NCT07599111

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests whether inhaling tiny particles from stem cells (exosomes) can help heal lung inflammation caused by immunotherapy drugs. The study involves 40 adults with cancer who have persistent lung problems despite standard steroid treatment. Participants will inhale either the exosome mist or a placebo twice daily for a week, and researchers will track lung healing and safety for 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nebulized human umbilical cord mesenchymal stem cell-derived exosomes
What this could lead to
If it works, this could offer a new way to treat lung inflammation caused by immunotherapy, potentially reducing the need for steroids.
What could go wrong
This is a very early, small study (40 people) focused on safety. The treatment is experimental, and it may not improve lung lesions or could cause side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 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

Oct 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 to 75 years

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.

Inclusion Criteria: * Informed consent: Signed written informed consent. * Age and diagnosis: Aged 18-75 years with histologically confirmed malignant tumor. * Treatment history: Received at least one cycle of immune checkpoint inhibitor therapy and developed immune checkpoint inhibitor-related pneumonitis. * Confirmed Grade 3-4 immune checkpoint inhibitor-related pneumonitis (CIP) by clinical evaluation (diagnosis and grading in accordance with the NCCN Guidelines for Management of Immunotherapy-Related Toxicities Version 1.2025), having received standard glucocorticoid therapy for ≥4 weeks, with glucocorticoids either discontinued or tapered to a prednisone-equivalent dose of \<20 mg/day. * Recent HRCT imaging: Persistent residual CIP-related lesions in both lungs, including ground-glass opacity, consolidation, reticular opacity, traction bronchiectasis, and/or honeycombing, involving a large extent of the lung fields; no significant resolution or improvement of these residual lesions on repeated HRCT within the past 4 weeks. * General condition: ECOG PS score 0-1, with stable control of the primary tumor for ≥6 months. * Contraception: Fertile subjects agree to use effective contraception during the study period and for 360 days after the last dose. Exclusion Criteria: * Concomitant medication: Current use of antifibrotic agents such as pirfenidone and nintedanib. * Operational limitation: Inability to cooperate with pulmonary function testing or nebulized inhalation. * History of other pulmonary diseases: Presence of unresolved interstitial lung disease or pulmonary fibrosis induced by targeted therapy, radiotherapy, or other causes. * Severe comorbidities: Including severe cardiac, hepatic, or renal insufficiency, or severe hematological abnormalities. * Specific medical history: Severe neuromuscular disease, history of organ transplantation, active epilepsy, primary or severe acquired/secondary immunodeficiency. * Other factors: Severe allergic constitution, psychiatric disorders, use of other investigational products within 28 days, or any other condition deemed inappropriate by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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  1. The official record

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