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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Airway Basal Stem Cells
Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
RECRUITINGChange 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
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Bronchiolitis Obliterans (BO) exacerbation
Frequency and severity of events will be evaluated
Time frame: 24 weeks after treatment