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Could inhaled stem cell therapy help stiff lungs?

NCT ID NCT07515066

Disease control Sponsor: Huan Ye Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 (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.

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 9 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

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: * 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.

  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

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Contacts and locations

Locations

  • Beijing Chest Hospital, Capital Medical University

    Beijing, China

More trials for these conditions

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