NCT06998706招募中1 期
REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in DLCO from baseline.
研究概览
简要总结
This clinical trial evaluates the safety and efficacy of REGEND001, an autologous bronchial basal layer stem cell therapy, in patients with interstitial lung disease (ILD). The treatment involves harvesting the patient's own stem cells (expressing KRT5/P63 markers), expanding them ex vivo, and administering them via bronchoscopic infusion to regenerate damaged lung tissue.
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
- •Age 40-75 years.
- •Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).
- •DLCO ≥30% and <80% predicted.
排除标准
- •Pregnancy, lactation, or plans for pregnancy within 1 year.
- •Active malignancy or history of malignancy.
- •Positive serology for HIV, HBV, HCV, or syphilis.
研究组 & 干预措施
ICD patients
Experimental
干预措施: REGEND001 Autologous Basal Layer Stem Cell Suspension (Biological)
结局指标
主要结局
Change in DLCO from baseline.
时间窗: Baseline, 4 weeks post treatment, 24 weeks post treatment
The diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement of the gas transfer capacity of lung.
次要结局
- Change in FVC from baseline(Baseline, 4 weeks post treatment, 24 weeks post treatment)
- Incidence of adverse events and serious adverse events.(Through study completion, an average of 6 months)
- High-resolution CT (HRCT) imaging scores(Baseline, 4 weeks post treatment, 24 weeks post treatment)
- Quality of life (QoL) assessment via validated respiratory questionnaires(Baseline, 4 weeks post treatment, 24 weeks post treatment)
研究者
研究点 (2)
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