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Recruiting NCT07239895

Treatment of Pediatric Bronchiolitis Obliterans by Airway Basal Stem Cells

Early Phase I Interventional Pediatric Bronchiolitis Obliterans

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Airway Basal Stem Cells.
Who it may be relevant to
Registry conditions: Pediatric Bronchiolitis Obliterans. Basic parameters: 28 Days — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

The study is co-sponsored by Regend Therapeutics and Shanghai Children's Hospital.

Interventions

  • Biological Airway Basal Stem Cells
    Airway Basal Stem Cells

Primary outcome measures

  • Change in clinical symptoms [Time frame: 12 and 24 weeks after treatment]
  • Changes in oxygen therapy [Time frame: 24 weeks after treatment]
Secondary outcome measures (6)
  • Changes in general condition [Time frame: 24 weeks after treatment]
  • Change in lung diffusing capacity for carbon monoxide (DLCO) from baseline [Time frame: 12 and 24 weeks after treatment]
  • Change in forced expiratory volume in one second (FEV1) from baseline [Time frame: 12 and 24 weeks after treatment]
  • Change in forced vital capacity (FVC) from baseline [Time frame: 12 and 24 weeks after treatment]
  • Change in high resolution computed tomography (HRCT) from baseline [Time frame: 24 weeks after treatment]
  • Bronchiolitis Obliterans (BO) exacerbation [Time frame: 24 weeks after treatment]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai

Identifiers

NCT: NCT07239895 · BO-V1.2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗