NCT05638776已完成2 期
A Multicenter, Randomized, Single-Blind, Placebo-Parallel-Controlled Research of REGEND001 Cell Therapy for Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect
Regend Therapeutics8 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年12月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 8
- 主要终点
- Change of lung diffusing capacity for carbon monoxide (DLCO) from baseline
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide with the characterization of obstructed airflow. In a large number of patients, diffusion function is impaired along with the progression of disease. REGEND001 cell therapy, comprised of airway basal cells with ability to regenerate lung tissue, is promising to COPD treatment. In this study, a multicenter, randomized, single-blind, placebo-parallel-controlled trial is performed to assess the efficacy and safety of REGEND001 cell therapy in treatment of chronic obstructive pulmonary disease with diffusion capacity defect.
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
- Single (Participant)
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 to 75 at the time of signing informed consent.
- •Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD).
- •The ratio of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)FEV1/FVC is < 70% after inhalation of bronchodilators.
- •The diffusion function of carbon monoxide (DLCO) is ≥ 20% and < 80% of the predicted value at screening.
- •Tolerated to pulmonary function tests.
- •Tolerated to bronchoscopy
- •Voluntary to sign the informed consent, coordinated to finish the trial-related procedures and tests, and capable of recording or stating the change of disease condition in a relatively complete manner.
排除标准
- •Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant);
- •Subject positive in each of the tests containing treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody at screening. But except the followings:
- •Hepatitis B virus carriers (only HBsAg positive without any hepatitis symptom or sign, and all liver function tests present normal results or abnormal markers without clinical significance by the assessment of investigators);
- •Cured hepatitis C patients (negative in HCV ribonucleic acid (RNA) test);
- •Subject with assessed survival time of < 1 year by investigators at screening;
- •Subject with malignant tumors or a history of malignant tumors at screening;
- •Subject with infections in lung or other sites, requiring intravenous drug treatment within a week prior to screening;
- •Subject with more than 4 moderate-to-severe AECOPD, resulting in hospitalization within a year prior to screening;
- •Subject with one or more pathogenetic or serologic findings of the novel coronavirus infection, or symptoms of suspected infection within 6 weeks prior to screening;
- •Subject with a history of invasive or noninvasive mechanical ventilation within 4 weeks prior to screening;
- •Subject who has taken prednisone tablets orally at a dose of ≥ 20 mg/day (or equivalent amount of other oral corticosteroids) within 4 weeks prior to screening;
- •Subject with major lung diseases other than COPD by assessment of investigators at screening;
- •Subject with severe systemic diseases other than lung within 6 months prior to screening and assessed to be inappropriate to participate in this trial by investigators;
- •Subject with severe anemia or poorly controlled granulocyte deficiency, thrombocytopenia by assessment of investigators;
- •Subject with abnormal coagulation and assessed to be negative for the safety of fiberoptic bronchoscopy operations at screening;
- •Subject requiring long-term anticoagulation therapy of using antiplatelet coagulant therapeutic agents and disable to discontinue their medications 1 week prior to cell collection and cell infusion as assessed by investigators;
- •Subject with a risk of suicide, a history of mental illness or a history of epilepsy at screening;
- •Subject with severe arrhythmias or heart conduction disorders (degree II or above) in 12-lead ECG test at screening;
- •Subject participated in other clinical trials with interventions within 3 months prior to screening;
- •Investigators, co-investigators, research coordinators, employees of research participants or research centers, or their family members;
- •Any circumstance considered to probably increase the risk of patients or interfere with the clinical trial.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change of lung diffusing capacity for carbon monoxide (DLCO) from baseline
时间窗: Within 52 weeks after treatment
DLCO is considered a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.
次要结局
- Change of the alveolar volume (VA) from baseline(Winthin 52 weeks after treatment)
- Change of images of lung by high resolution computed tomography (HR-CT) from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Change of forced vital capacity (FVC) from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Change of forced expiratory volume in one second (FEV1) from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Change of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Change of the diffusing capacity for carbon monoxide/ the alveolar volume (DLCO/VA) from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Change of 6-minute-walk test (6MWT) from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Change of modified medical research council (mMRC) dyspnea scale from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Change of chronic obstructive pulmonary disease Assessment Test (CAT) from baseline(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Annual frequency of exacerbations(1 year after treatment)
- Symptoms, physical examination(Baseline, treatment day (D1), 24 hours after treatment, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- 12-lead ECG(4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Blood routine(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Urine routine(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Blood biochemistry(Baseline, 4 weeks after treatment, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Function of blood clotting(Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Carcinoembryonic antigen (CEA)(Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Neuron-specific enolase (NSE)(Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Cytokeratin-19-fragment (CYFRA21-1)(Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
- Squamous cell carcinoma antigen (SCC)(Baseline, 12 weeks after treatment, 24 weeks after treatment, 52 weeks after treatment)
研究者
研究点 (8)
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