Bronchiolitis Obliterans Clinical Trials

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Exploratory Study of Airway Basal Stem Cells on Treatment of Pediatric Bronchiolitis Obliterans

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 28 days
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University
RECRUITING
Shanghai
Contact Information
Primary
Liling Qian, Professor and Chief Physician
qianliling@shchildren.com.cn
086-021-62474880
Time Frame
Start Date: 2025-11-11
Estimated Completion Date: 2027-11
Participants
Target number of participants: 12
Treatments
Experimental: Airway Basal Stem Cells
Related Therapeutic Areas
Sponsors
Leads: Regend Therapeutics
Collaborators: Shanghai Children's Hospital

This content was sourced from clinicaltrials.gov