A Multicenter, Randomized, Blinded, Placebo-Controlled Confirmatory Clinical Trial of Autologous REGEND001 Cell Therapy for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a common, progressive, and heterogeneous respiratory disorder. It is associated with substantial morbidity and mortality worldwide, leading to progressive decline in lung function, impaired quality of life, and a significant healthcare burden. REGEND001, made from airway basal stem cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, blinded, placebo-parallel-controlled trial is performed to verify the efficacy and safety of REGEND001 in treatment of COPD patients with emphysema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Male or female, aged 40-75 years；
- •Diagnosed with COPD;
- •Post-bronchodilator FEV1/FVC <0.7
- •Emphysematous lesions demonstrated by HRCT;
- •Hemoglobin-corrected DLCO%predicted ≥20% and <70%;
- •Post-bronchodilator FEV1%predicted ≤80%;
- •COPD Assessment Test (CAT) score ≥3;
排除标准
- •History of ≥2 COPD exacerbations leading to hospitalization within 1 year prior to screening, or a COPD exacerbation leading to hospitalization within 2 months prior to screening;
- •Current or previous history of malignancy;
- •An assessed life expectancy of <1 year;
- •Respiratory tract infection or systemic infection requiring treatment, or severe localized infection within 4 weeks prior to screening;
- •History of invasive or non-invasive mechanical ventilation within 4 weeks prior to screening;
- •Diagnosis of pneumonia within 3 months prior to screening;
- •Abnormal coagulation function affecting the safety of fiberoptic bronchoscopy procedures at screening;
- •Subjects requiring long-term maintenance anticoagulant therapy or antiplatelet therapy, who are unable to discontinue such medications for at least 1 week prior to cell collection and cell infusion;
研究组 & 干预措施
REGEND001
Participants randomized to the experimental arm will receive a single administration of REGEND001.
干预措施: REGEND001 (Biological)
Placebo
Participants randomized to the Placebo Comparator arm will receive a single administration of placebo.
干预措施: Placebo (Biological)
结局指标
主要结局
Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）
时间窗: Week 52 after treatment
The change from baseline in measured DLCO is defined as the difference between the absolute measured DLCO value at baseline and that measured at the assessment time point after treatment.
次要结局
- Change from baseline in COPD Assessment Test (CAT) score(Week 12, 24 and 52 after treatment)
- Proportion of subjects with a ≥2-point improvement or worsening from baseline in CAT score(Week 12, 24 and 52 after treatment)
- Change from baseline in DLCO(Week 12, 24 and 52 after treatment)
- Proportion of subjects with a ≥11% relative improvement or worsening from baseline in absolute measured DLCO(Week 12, 24 and 52 after treatment)
- Change from baseline in alveolar volume (VA)(Week 12, 24 and 52 after treatment)
- Change from baseline in forced expiratory volume in the first second (FEV1) post-bronchodilator(Week 12, 24 and 52 after treatment)
- Change from baseline in 6-minute walk distance (6MWD)(Week 12, 24 and 52 after treatment)
- Proportion of subjects with a ≥30-meter change from baseline in 6MWD(Week 12, 24 and 52 after treatment)
- Change from baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) score(Week 12, 24 and 52 after treatment)
- Proportion of subjects with a ≥4-point improvement or worsening from baseline in SGRQ-C score(Week 12, 24 and 52 after treatment)
- Annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics(Week 52 after treatment)
- Change from baseline in arterial blood gas parameters(Week 52 after treatment)
- Change from baseline in HRCT images(Week 52 after treatment)
- Adverse Event(Hour 24, Week 12, 24 and 52 after treatment)