Could inhaled stem cell therapy help stiff lungs?
NCT ID NCT07515066
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether inhaling tiny particles from stem cells (extracellular vesicles) is safe for people with idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs and makes breathing hard. Nine adults with mild-to-moderate IPF will inhale the treatment twice daily for a week, then be followed for a year. The main goal is to check for side effects and find the best dose, while also looking at lung function and breathing symptoms.
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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 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
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: * Age 18 to 75 years, male or female at the time of signing the informed consent form. * Confirmed diagnosis of idiopathic pulmonary fibrosis (IPF) in accordance with the 2022 ATS/ERS/JRS/ALAT clinical criteria. * Forced vital capacity (FVC) ≥50% and ≤80% of predicted value, and hemoglobin-corrected diffusing capacity of the lung for carbon monoxide (DLCO) ≥30% and ≤80% of predicted value at screening. * Stable dose of antifibrotic therapy (nintedanib, pirfenidone, or nerandomilast) for at least 8 weeks prior to screening. * 6-minute walking distance (6MWD) \>150 meters at screening. * Willing to use effective contraception during the study and for 12 months after the last dose of study treatment (for subjects of childbearing potential, including male subjects whose spouses are of childbearing potential). * Signed and dated written informed consent form prior to any study-related procedures. * Able to comply with all study procedures and scheduled follow-up visits. Exclusion Criteria: * Prior treatment with stem cell-derived products or extracellular vesicles for any disease. * Inability to tolerate nebulized inhalation therapy. * History of severe drug allergy or anaphylaxis to any component of the study treatment or nebulization materials. * Diagnosis of bronchial asthma or other active respiratory diseases that may interfere with study assessments. * Pregnant, breastfeeding, or planning pregnancy within 12 months after the last dose of study treatment. * Malignancy within 5 years prior to screening (except adequately treated basal cell carcinoma or cervical carcinoma in situ). * Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). * History of solid organ or hematopoietic stem cell transplantation, or being on the transplant waiting list. * Requirement for long-term oxygen therapy for more than 15 hours per day. * Severe cardiac, hepatic, renal, or other systemic diseases that, in the investigator's judgment, would compromise study participation or confound study results. * Participation in another interventional clinical trial within 3 months prior to screening.
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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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Beijing Chest Hospital, Capital Medical University
Beijing, China
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