NCT07239895 Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells
| NCT ID | NCT07239895 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Regend Therapeutics |
| Condition | Pediatric Bronchiolitis Obliterans |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-11-11 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2025-11-11 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07239895 clinical trial?
This trial is open to participants of all sexes, aged 28 Days or older, up to 18 Years, studying Pediatric Bronchiolitis Obliterans. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07239895 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07239895 currently recruiting?
Yes, NCT07239895 is actively recruiting participants. Contact the research team at qianliling@shchildren.com.cn for enrollment information.
Where is the NCT07239895 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07239895 clinical trial?
NCT07239895 is sponsored by Regend Therapeutics. The trial plans to enroll 12 participants.