Can stem cell mist heal lungs damaged by cancer immunotherapy?
NCT ID NCT07599111
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 40 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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Oct 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 to 75 years
- 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.
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
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 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.
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