Could stem cells repair damaged airways in kids?
NCT ID NCT07239895
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether airway basal stem cells can safely help children with bronchiolitis obliterans, a chronic lung disease that narrows airways. About 12 children aged 28 days to 18 years will receive the cells via bronchoscopy. Researchers will check for improvements in coughing, wheezing, breathing, and oxygen needs.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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28 days to 18 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: * Males and females, aged between 28 days and 18 years; * Diagnosed with bronchiolitis obliterans according to the guidelines; * Meeting at least one of the following: FEV1 \< 55% of predicted value; requiring continuous assisted mechanical ventilation or oxygen therapy; * None of acute infections within the past four weeks; * Tolerating bronchoscopy; * The child and/or parent(s) provide informed consent, and are able to understand and adhere to scheduled visits, treatments, laboratory tests, and other study procedures. Exclusion Criteria: * Subjects with bronchiolitis obliterans syndrome (BOS) who are on a current cGVHD treatment regimen at screening. * At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test. Hepatitis B virus carriers with stable current condition can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well. * Subject who is assessed to have major lung diseases other than BO by investigators at screening or who has other severe systemic diseases within 6 months prior to screening and is considered to be unsuitable for this study by investigators. * Presence of severe coagulation dysfunction at screening and may compromise the safety of bronchoscopy in the investigator's judgment. * Subjects requiring long-term maintenance anticoagulant therapy or antiplatelet aggregation therapy, and for whom, in the investigator's assessment, the medication cannot be discontinued within a week prior to cell collection and infusion. * Subjects with suicide risk or a history of psychiatric disorders at screening. * Participation in another interventional clinical study within 3 months prior to screening. * Poor compliance, making him or her difficult to complete the study. * Subjects who is considered to be unsuitable for this study in in the opinion of 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 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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Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University
RECRUITINGShanghai, 200000, China
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