Pediatric Bronchiolitis ObliteransEarly Phase 1NCT07239895
Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells
A Early Phase 1 study testing Airway Basal Stem Cells in people with Pediatric Bronchiolitis Obliterans, run by Regend Therapeutics at 1 site in China.
Trial summary
Bronchiolitis obliterans (BO) is a chronic lung disease which was initiated with injury of the bronchiolar epithelium and resulted in nonuniform luminal obliteration or narrowing. Among children, the most common form of BO is post-infectious BO with a lack of treatment guidelines or standard therapy. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Pediatric Bronchiolitis Obliterans
- What is being tested?
- Airway Basal Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2025to Nov 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200000
Lei He, 086-021-52976581, hl@shchildren.com.cn
About this study
Official title: Exploratory Study of Airway Basal Stem Cells on Treatment of Pediatric Bronchiolitis Obliterans
Bronchiolitis obliterans (BO) is a chronic lung disease which was initiated with injury of the bronchiolar epithelium and resulted in nonuniform luminal obliteration or narrowing. Among children, the most common form of BO is post-infectious BO with a lack of treatment guidelines or standard therapy. In this study, an open, single-armed study is performed to preliminarily evaluate the safety and efficacy of airway basal stem cells on treatment of pediatric BO.
Read the detailed description
The study is co-sponsored by Regend Therapeutics and Shanghai Children's Hospital.
- Conditions
- Pediatric Bronchiolitis Obliterans
- Being tested
- Airway Basal Stem Cells
- Keywords
- Airway Basal Stem Cells, Bronchiolitis obliterans, Bronchiolar Epithelium, Pedatric Bronchiolitis Obliterans
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway Basal Stem CellsBiological
Airway Basal Stem Cells
| Study group | Role | What they receive |
|---|---|---|
| Airway Basal Stem Cells | Experimental | Not described Receives: Biological: Airway Basal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical symptoms
Cough, wheezing, respiratory rate are included in clinical symptomes. Both status and frequency would be evaluated.
Measured: 12 and 24 weeks after treatment
Changes in oxygen therapy
Oxygen saturation (SpO₂), oxygen therapy settings, and daily duration of oxygen therapy would be evaluated.
Measured: 24 weeks after treatment
Secondary outcomes (6)
Changes in general condition
Rate of weight gain, time of independent activity are evaluated as general condition.
Measured: 24 weeks after treatment
Change in lung diffusing capacity for carbon monoxide (DLCO) from baseline
DLCO is a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.
Measured: 12 and 24 weeks after treatment
Change in forced expiratory volume in one second (FEV1) from baseline
FEV1 is the volume of breath exhaled with effort in one second.
Measured: 12 and 24 weeks after treatment
Change in forced vital capacity (FVC) from baseline
FVC is the full amount of air that can be exhaled with effort in a complete breath
Measured: 12 and 24 weeks after treatment
Change in high resolution computed tomography (HRCT) from baseline
HRCT scan is a type of CT scan that shows detailed pictures of lungs
Measured: 24 weeks after treatment
Bronchiolitis Obliterans (BO) exacerbation
Frequency and severity of events will be evaluated
Measured: 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start11 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Bronchiolitis ObliteransStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regend Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239895
- Sponsor's protocol ID
- BO-V1.2
- Status last verified
- Sep 2025
- First submitted
- 16 Nov 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Airway Basal Stem Cells on Treatment of Pediatric Bronchiolitis Obliterans
- ClinicalTrials.gov ID
- NCT07239895
- Acronym / sponsor ID
- BO-V1.2
- Conditions
- Pediatric Bronchiolitis Obliterans
- Keywords
- Airway Basal Stem Cells, Bronchiolitis obliterans, Bronchiolar Epithelium, Pedatric Bronchiolitis Obliterans
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Regend TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Hospital
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bronchiolitis obliterans (BO) is a chronic lung disease which was initiated with injury of the bronchiolar epithelium and resulted in nonuniform luminal obliteration or narrowing. Among children, the most common form of BO is post-infectious BO with a lack of treatment guidelines or standard therapy. In this study, an open, single-armed study is performed to preliminarily evaluate the safety and efficacy of airway basal stem cells on treatment of pediatric BO.
Detailed description
The study is co-sponsored by Regend Therapeutics and Shanghai Children's Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway Basal Stem Cells | Experimental | Biological: Airway Basal Stem Cells |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway Basal Stem CellsAirway Basal Stem Cells | Biological | Airway Basal Stem Cells |
Primary outcome
Change in clinical symptoms
Time frame: 12 and 24 weeks after treatment
Cough, wheezing, respiratory rate are included in clinical symptomes. Both status and frequency would be evaluated.
Changes in oxygen therapy
Time frame: 24 weeks after treatment
Oxygen saturation (SpO₂), oxygen therapy settings, and daily duration of oxygen therapy would be evaluated.
6 secondary outcomes
Changes in general condition
Time frame: 24 weeks after treatment
Change in lung diffusing capacity for carbon monoxide (DLCO) from baseline
Time frame: 12 and 24 weeks after treatment
Change in forced expiratory volume in one second (FEV1) from baseline
Time frame: 12 and 24 weeks after treatment
Change in forced vital capacity (FVC) from baseline
Time frame: 12 and 24 weeks after treatment
Change in high resolution computed tomography (HRCT) from baseline
Time frame: 24 weeks after treatment
Bronchiolitis Obliterans (BO) exacerbation
Time frame: 24 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Airway Basal Stem Cells in people with Pediatric Bronchiolitis Obliterans, run by Regend Therapeutics at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liling Qian, Professor and Chief Physician (086-021-62474880, qianliling@shchildren.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical symptoms (time frame: 12 and 24 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.