A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
2026年9月14日 更新者：Regend Therapeutics
A Multicenter, Randomized, Blinded, Placebo-Controlled Confirmatory Clinical Trial of Autologous REGEND001 Cell Therapy for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
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.
研究概览
研究类型
介入性
注册 (估计的)
102
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Shiyue Li, Professor and Chief Physician
- 电话号码：86-20-83062114
- 邮箱：lishiyue@188.com
学习地点
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Guangdong
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Guangzhou、Guangdong、中国
- The First Affiliated Hospital of Guangzhou Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Placebo
Participants randomized to the Placebo Comparator arm will receive a single administration of placebo.
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Participants enrolled will have a bronchoscopy with brushing for cell collection, followed by a single adiministratoin of placebo via bronchoscopy and 1 year of follow-up.
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实验性的：REGEND001
Participants randomized to the experimental arm will receive a single administration of REGEND001.
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Participants enrolled will have a bronchoscopy with brushing for cell collection, followed by a single adiministratoin of REGEND001 via bronchoscopy and 1 year of follow-up.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）
大体时间：Week 52 after treatment
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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.
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Week 52 after treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline in COPD Assessment Test (CAT) score
大体时间：Week 12, 24 and 52 after treatment
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The change from baseline in CAT score is defined as the difference between the CAT score at baseline and the CAT score measured at the specified post-treatment assessment time point.
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Week 12, 24 and 52 after treatment
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Proportion of subjects with a ≥2-point improvement or worsening from baseline in CAT score
大体时间：Week 12, 24 and 52 after treatment
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Minimal clinically important difference for CAT is recognized as 2 points.
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Week 12, 24 and 52 after treatment
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Change from baseline in DLCO
大体时间：Week 12, 24 and 52 after treatment
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DLCO is assessed by absolute measured value, hemoglobin (Hb)-corrected measured/predicted ratios and corresponding area under curve (AUC).
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Week 12, 24 and 52 after treatment
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Proportion of subjects with a ≥11% relative improvement or worsening from baseline in absolute measured DLCO
大体时间：Week 12, 24 and 52 after treatment
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Minimal clinically important difference (MCID) of DLCO is recognized as 11%.
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Week 12, 24 and 52 after treatment
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Change from baseline in alveolar volume (VA)
大体时间：Week 12, 24 and 52 after treatment
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VA is assessed by measured values, measured/predicted ratio and corresponding area under curve (AUC).
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Week 12, 24 and 52 after treatment
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Change from baseline in forced expiratory volume in the first second (FEV1) post-bronchodilator
大体时间：Week 12, 24 and 52 after treatment
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FEV1 is assessed by measured value, measured/predicted ratio and corresponding area under curve (AUC).
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Week 12, 24 and 52 after treatment
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Change from baseline in 6-minute walk distance (6MWD)
大体时间：Week 12, 24 and 52 after treatment
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6MWD is assessed by the measured value and corresponding area under curve
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Week 12, 24 and 52 after treatment
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Proportion of subjects with a ≥30-meter change from baseline in 6MWD
大体时间：Week 12, 24 and 52 after treatment
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Minimal clinically important difference (MCID) of 6MWD is recognized as 30 meters.
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Week 12, 24 and 52 after treatment
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Change from baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) score
大体时间：Week 12, 24 and 52 after treatment
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The St. George's Respiratory Questionnaire for COPD (SGRQ-C) is a validated disease-specific patient-reported outcome measure used to assess the impact of COPD on patients' health status and quality of life.
Total score, ranged from 0 to 100, is the sum of points from all items.
A higher value represents a worse outcome.
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Week 12, 24 and 52 after treatment
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Proportion of subjects with a ≥4-point improvement or worsening from baseline in SGRQ-C score
大体时间：Week 12, 24 and 52 after treatment
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Minimal clinically important difference for SGRQ is recognized as 4 points.
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Week 12, 24 and 52 after treatment
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Annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics
大体时间：Week 52 after treatment
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The annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics, represents the adjusted frequency of acute exacerbations of COPD over the assessment period.
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Week 52 after treatment
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Change from baseline in arterial blood gas parameters
大体时间：Week 52 after treatment
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The change from baseline in arterial blood gas parameters reflects changes in gas exchange function and respiratory status over the assessment period.
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Week 52 after treatment
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Change from baseline in HRCT images
大体时间：Week 52 after treatment
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HRCT images are quantitatively analyzed using dedicated software to measure emphysema volume (mL) and functional lung volume (mL).
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Week 52 after treatment
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Adverse Event
大体时间：Hour 24, Week 12, 24 and 52 after treatment
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An adverse event (AE) is any untoward medical occurrence in a subject who has received a study intervention, regardless of whether or not it is considered related to the intervention.
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Hour 24, Week 12, 24 and 52 after treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2028年9月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年9月14日
首先提交符合 QC 标准的
2026年9月14日
首次发布 (实际的)
2026年9月18日
研究记录更新
最后更新发布 (实际的)
2026年9月18日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- REGEND001-COPD-251
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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