Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells
ConditionPediatric Bronchiolitis Obliterans
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age28-18
SponsorRegend Therapeutics
About this trial
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
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Airway Basal Stem Cells
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Regend Therapeutics
Lead sponsor
Shanghai Children's Hospital
Collaborator
Source ClinicalTrials.gov