Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Increase of diffusing capacity of the lung for carbon monoxide (DLCO)
研究概览
简要总结
Interstitial lung diseases (ILD) are a group of diseases affecting the lung interstitium. The lung scarring that occurs in ILD is often irreversible with only mitigating therapy available so far. This study intends to carry out an open, single-armed, phase I/II clinical trial to investigate whether lung stem cells can regenerate damaged lung tissue. During the treatment, lung stem cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with interstitial lung disease
- •Clinically stable
- •Written informed consent signed
排除标准
- •Allergic to cell therapy;
- •Patients with serious significant pulmonary infection need anti-infection treatment;
- •Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months;
- •Patients with malignant tumor in the past 5 years;
- •Participated in other clinical trials in the past 3 months;
- •Patients with serious heart disease(NYHA class Ⅲ-Ⅳ)
- •Pregnant or lactating women;
- •The investigator assessed as inappropriate to participate in this clinical trial.
结局指标
主要结局
Increase of diffusing capacity of the lung for carbon monoxide (DLCO)
时间窗: 24 weeks
次要结局
- Increase in 6 minute walk distance (6MWD)(24 weeks)
- Life quality: assessed by St. George respiratory questionnaire (SGRQ)(24 weeks)
- Increase of total lung capacity (TLC)(24 weeks)
研究者
Wei Zuo
Professor
Shanghai East Hospital