Actively Recruiting
Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells
Led by Regend Therapeutics · Updated on 2026-01-14
12
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
R
Regend Therapeutics
Lead Sponsor
S
Shanghai Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females, aged between 28 days and 18 years
- Diagnosed with bronchiolitis obliterans according to guidelines
- Meeting at least one: FEV1 less than 55% predicted, or requiring continuous assisted mechanical ventilation or oxygen therapy
- No acute infections within the past four weeks
- Able to tolerate bronchoscopy
- Child and/or parent(s) provide informed consent and can follow study visits, treatments, and tests
You will not qualify if you...
- Subjects on current cGVHD treatment for bronchiolitis obliterans syndrome at screening
- Positive for treponema pallidum antibody, HIV antibody, hepatitis B surface antigen, or hepatitis C antibody at screening (hepatitis B carriers with stable condition and cured hepatitis C patients with negative RNA test may enroll)
- Major lung diseases other than BO or severe systemic diseases within 6 months prior to screening
- Severe coagulation dysfunction at screening
- Need for long-term anticoagulant or antiplatelet therapy that cannot be stopped within a week before cell collection and infusion
- Suicide risk or history of psychiatric disorders at screening
- Participation in another interventional clinical study within 3 months prior to screening
- Poor compliance making study completion difficult
- Considered unsuitable for the study by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China, 200000
Actively Recruiting
Research Team
L
Liling Qian, Professor and Chief Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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