An Early Phase 1 interventional study of Airway Basal Stem Cells in Pediatric Bronchiolitis Obliterans, sponsored by Regend Therapeutics. Recruiting at 1 site in China. Open to participants aged 28 Days to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Regend Therapeutics · Early Phase 1, Interventional, and Treatment
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.
The study is co-sponsored by Regend Therapeutics and Shanghai Children's Hospital.
87 studies on the registry are indexed under Bronchiolitis Obliterans; 11 are open to participants now.
This study's planned enrollment of 12 is below the median of 30 across 59 interventional studies indexed under Bronchiolitis Obliterans.
Browse Bronchiolitis Obliterans studies →Regend Therapeutics is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Airway Basal Stem Cells
Airway Basal Stem Cells
Change in clinical symptoms
Cough, wheezing, respiratory rate are included in clinical symptomes. Both status and frequency would be evaluated.
Time frame: 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.
Time frame: 24 weeks after treatment
Changes in general condition
Rate of weight gain, time of independent activity are evaluated as general condition.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 24 weeks after treatment
Bronchiolitis Obliterans (BO) exacerbation
Frequency and severity of events will be evaluated
Time frame: 24 weeks after treatment
Plan to share: No
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Regend Therapeutics