[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656588":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":58,"studyPopulation":58,"armGroups":68,"interventions":81,"overallOfficials":58,"centralContacts":89,"locations":95,"responsibleParty":108,"collaborators":58,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":58,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":58,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":133,"whyStopped":58,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Regend Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":58},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in the measured Diffusing Capacity of the Lung for Carbon Monoxide (DLCO）","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.","Week 52 after treatment",[14,18,21,24,27,30,33,36,39,42,45,48,51,54],{"measure":15,"description":16,"timeFrame":17},"Change from baseline in COPD Assessment Test (CAT) score","The COPD Assessment Test (CAT) is an 8-item questionnaire used to assess the impact of COPD on health status. The total score ranges from 0 to 40, with higher scores indicating a greater impact of COPD and worse health status. Change from baseline is calculated as the post-treatment CAT score minus the baseline CAT score.","Week 12, 24 and 52 after treatment",{"measure":19,"description":20,"timeFrame":17},"Proportion of subjects with a ≥2-point improvement or worsening from baseline in CAT score","Minimal clinically important difference for CAT is recognized as 2 points.",{"measure":22,"description":23,"timeFrame":17},"Change from baseline in DLCO","DLCO is assessed by absolute measured value, hemoglobin (Hb)-corrected measured\u002Fpredicted ratios and corresponding area under curve (AUC).",{"measure":25,"description":26,"timeFrame":17},"Proportion of subjects with a ≥11% relative improvement or worsening from baseline in absolute measured DLCO","Minimal clinically important difference (MCID) of DLCO is recognized as 11%.",{"measure":28,"description":29,"timeFrame":17},"Change from baseline in alveolar volume (VA)","VA is assessed by measured values, measured\u002Fpredicted ratio and corresponding area under curve (AUC).",{"measure":31,"description":32,"timeFrame":17},"Change from baseline in forced expiratory volume in the first second (FEV1) post-bronchodilator","FEV1 is assessed by measured value, measured\u002Fpredicted ratio and corresponding area under curve (AUC).",{"measure":34,"description":35,"timeFrame":17},"Change from baseline in 6-minute walk distance (6MWD)","6MWD is assessed by the measured value and corresponding area under curve",{"measure":37,"description":38,"timeFrame":17},"Proportion of subjects with a ≥30-meter change from baseline in 6MWD","Minimal clinically important difference (MCID) of 6MWD is recognized as 30 meters.",{"measure":40,"description":41,"timeFrame":17},"Change from baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) score","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.",{"measure":43,"description":44,"timeFrame":17},"Proportion of subjects with a ≥4-point improvement or worsening from baseline in SGRQ-C score","Minimal clinically important difference for SGRQ is recognized as 4 points.",{"measure":46,"description":47,"timeFrame":12},"Annualized rate of COPD exacerbations (AECOPD), adjusted for prior exacerbation history and baseline characteristics","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.",{"measure":49,"description":50,"timeFrame":12},"Change from baseline in arterial blood gas parameters","The change from baseline in arterial blood gas parameters reflects changes in gas exchange function and respiratory status over the assessment period.",{"measure":52,"description":53,"timeFrame":12},"Change from baseline in HRCT images","HRCT images are quantitatively analyzed using dedicated software to measure emphysema volume (mL) and functional lung volume (mL).",{"measure":55,"description":56,"timeFrame":57},"Adverse Event","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.","Hour 24, Week 12, 24 and 52 after treatment",null,{"allocation":60,"interventionModel":61,"interventionModelDescription":58,"primaryPurpose":62,"observationalModel":58,"timePerspective":58,"maskingInfo":63},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":64,"maskingDescription":58,"whoMasked":65},"DOUBLE",[66,67],"PARTICIPANT","OUTCOMES_ASSESSOR",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"Placebo","PLACEBO_COMPARATOR","Participants randomized to the Placebo Comparator arm will receive a single administration of placebo.",[74],"Biological: Placebo",{"label":76,"type":77,"description":78,"interventionNames":79},"REGEND001","EXPERIMENTAL","Participants randomized to the experimental arm will receive a single administration of REGEND001.",[80],"Biological: REGEND001",[82,86],{"type":83,"name":70,"description":84,"armGroupLabels":85,"otherNames":58},"BIOLOGICAL","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.",[70],{"type":83,"name":76,"description":87,"armGroupLabels":88,"otherNames":58},"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.",[76],[90],{"name":91,"role":92,"phone":93,"phoneExt":58,"email":94},"Shiyue Li, Professor and Chief Physician","CONTACT","86-20-83062114","lishiyue@188.com",[96],{"facility":97,"status":58,"city":98,"state":99,"zip":58,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":58},"The First Affiliated Hospital of Guangzhou Medical University","Guangzhou","Guangdong","China","CN",{"type":103,"coordinates":104},"Point",[105,106],113.25,23.11667,{"lat":106,"lon":105},{"type":109,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR","100656588","phase-3-a-clinical-study-of-regend001-for-the-treatment-of-chronic-obstructive-pulmonary-disease-copd-100656588",false,"NCT07828353","A Clinical Study of REGEND001 for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)","A Multicenter, Randomized, Blinded, Placebo-Controlled Confirmatory Clinical Trial of Autologous REGEND001 Cell Therapy for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)","Inclusion Criteria:\n\n* Male or female, aged 40-75 years；\n* Diagnosed with COPD;\n* Post-bronchodilator FEV1\u002FFVC \\\u003C0.7\n* Emphysematous lesions demonstrated by HRCT;\n* Hemoglobin-corrected DLCO%predicted ≥20% and \\\u003C70%;\n* Post-bronchodilator FEV1%predicted ≤80%;\n* COPD Assessment Test (CAT) score ≥3;\n\nExclusion Criteria:\n\n* 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;\n* Current or previous history of malignancy;\n* An assessed life expectancy of \\\u003C1 year;\n* Respiratory tract infection or systemic infection requiring treatment, or severe localized infection within 4 weeks prior to screening;\n* History of invasive or non-invasive mechanical ventilation within 4 weeks prior to screening;\n* Diagnosis of pneumonia within 3 months prior to screening;\n* Abnormal coagulation function affecting the safety of fiberoptic bronchoscopy procedures at screening;\n* 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;","ALL","40 Years","75 Years",{"count":121,"type":122},102,"ESTIMATED","INTERVENTIONAL",[125],"PHASE3","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.",[128],"COPD (Chronic Obstructive Pulmonary Disease)",[130,131,132],"airway basal stem cells","regenerative medicine","COPD","NOT_YET_RECRUITING","2026-09-21",{"date":136,"type":137},"2026-09-24","ACTUAL",{"date":139,"type":122},"2026-10",{"date":141,"type":122},"2028-09",{"name":5,"class":6},1]