Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells

NCT07239895 | Recruiting Early Phase 1

• 1 other identifier: BO-V1.2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Bronchiolitis Obliterans

Keywords

Airway Basal Stem Cells; Bronchiolitis obliterans; Bronchiolar Epithelium; Pedatric Bronchiolitis Obliterans

Outcome Measures

Primary Outcomes (2)

• Change in clinical symptoms

  Cough, wheezing, respiratory rate are included in clinical symptomes. Both status and frequency would be evaluated.

  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.

  24 weeks after treatment

Secondary Outcomes (6)

• Changes in general condition

  24 weeks after treatment

• Change in lung diffusing capacity for carbon monoxide (DLCO) from baseline

  12 and 24 weeks after treatment

• Change in forced expiratory volume in one second (FEV1) from baseline

  12 and 24 weeks after treatment

• Change in forced vital capacity (FVC) from baseline

  12 and 24 weeks after treatment

• Change in high resolution computed tomography (HRCT) from baseline

  24 weeks after treatment

Study Arms (1)

Airway Basal Stem Cells

EXPERIMENTAL

Biological: Airway Basal Stem Cells

Interventions

Airway Basal Stem Cells BIOLOGICAL

Airway Basal Stem Cells

Airway Basal Stem Cells

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects requiring long-term maintenance anticoagulant therapy or antiplatelet aggregation therapy, and for whom, in the investigator's assessment, the medication cannot be discontinued within a week prior to cell collection and infusion.
• Subjects with suicide risk or a history of psychiatric disorders at screening.
• Participation in another interventional clinical study within 3 months prior to screening.
• Poor compliance, making him or her difficult to complete the study.
• Subjects who is considered to be unsuitable for this study in in the opinion of the investigator.

Sponsors & Collaborators

• Regend Therapeutics: lead
• Shanghai Children's Hospital: collaborator

Study Sites (1)

Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200000, China

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Central Study Contacts

Liling Qian, Professor and Chief Physician

CONTACT

086-021-62474880; qianliling@shchildren.com.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)