NCT07239895招募中1 期
Exploratory Study of Airway Basal Stem Cells on Treatment of Pediatric Bronchiolitis Obliterans
Regend Therapeutics1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年11月11日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in clinical symptoms
研究概览
简要总结
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.
详细描述
The study is co-sponsored by Regend Therapeutics and Shanghai Children's Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Airway Basal Stem Cells
Experimental
干预措施: Airway Basal Stem Cells (Biological)
结局指标
主要结局
Change in clinical symptoms
时间窗: 12 and 24 weeks after treatment
Cough, wheezing, respiratory rate are included in clinical symptomes. Both status and frequency would be evaluated.
Changes in oxygen therapy
时间窗: 24 weeks after treatment
Oxygen saturation (SpO₂), oxygen therapy settings, and daily duration of oxygen therapy would be evaluated.
次要结局
- 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)
- Bronchiolitis Obliterans (BO) exacerbation(24 weeks after treatment)
研究者
研究点 (1)
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