Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT07239895
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Days
Maximum Age:
18 Years
Study:
NCT07239895
Study Brief:
Protocol Section:
NCT07239895