Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-03-14 @ 5:32 AM
Study NCT ID:
NCT03608592
Status:
UNKNOWN
Last Update Posted:
2019-09-04
First Post:
2018-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Umbilical Cord Mesenchymal Stem Cells (MSCs) Therapy in ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-11-02', 'releaseDate': '2023-01-08'}, {'resetDate': '2024-04-25', 'releaseDate': '2023-11-21'}], 'estimatedResultsFirstSubmitDate': '2023-01-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013535', 'term': 'Suspensions'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A package of 100ml normal saline with 10\\^6/kg umbilical cord derived MSCs suspension will infused from central venous catheter.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-31', 'studyFirstSubmitDate': '2018-07-10', 'studyFirstSubmitQcDate': '2018-07-23', 'lastUpdatePostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Epithelial injury biomarker-KL6', 'timeFrame': 'From day 0 to day 7, day0, 1,3,7', 'description': 'Detect Krebs von den Lungen-6(KL6) level in bronchoalveolar fluid (BALF), unit-U/ml'}, {'measure': 'Endothelial injury biomarker-Ang2', 'timeFrame': 'From day 0 to day 7, day0, 1,3,7', 'description': 'Detect the angiopoietin (Ang2) level in plasma, unit-pg/ml'}, {'measure': 'Tumor necrosis factor a(TNFa)', 'timeFrame': 'From day 0 to day 7, day0, 1,3,7', 'description': 'Detect the TNFa in plasma and in BALF, unit-pg/ml'}, {'measure': 'Interleukin 8(IL8)', 'timeFrame': 'From day 0 to day 7, day0, 1,3,7', 'description': 'Detect the IL8 in plasma and in BALF, unit-pg/ml'}, {'measure': 'Interleukin 6(IL6)', 'timeFrame': 'From day 0 to day 7, day0, 1,3,7', 'description': 'Detect the IL6 in plasma and in BALF, unit-pg/ml'}], 'primaryOutcomes': [{'measure': 'Infusion associated events', 'timeFrame': 'From infusion beginning to the second day, 24 hours', 'description': 'Incidence of prescribed adverse events or unprescribed events agreed by investigators and consultant .'}, {'measure': 'Mortality', 'timeFrame': 'In 60 days after enrolled', 'description': 'All cause mortality. Cause of death, exact survival status (death/survival) and time (days) will also be recorded'}], 'secondaryOutcomes': [{'measure': 'Ventilation free days(VFDs)', 'timeFrame': 'From the day of UCMSCs use(day 0) to day 28', 'description': 'The days without invasive ventilator support(at least 2 consecutive calendar days) in 28 days.\n\nIf the ventilator weaned multiple times, VFDs is the sum of the days without ventilator support.\n\nIf any of following occurring in 28 days, VFDs equals 0:\n\n1. The patient dies in 28 days;\n2. Ventilator never be weaned;\n3. Censored case with ventilator never being weaned.'}, {'measure': 'Oxygenation index(OI) changes', 'timeFrame': 'From day 0 to day 7, each day', 'description': 'The oxygenation index(OI)=partial pressure of oxygen in arterial blood(PaO2) divide inspiration fraction of oxygen(FiO2). OI is measured at day0, day1,day3,day7.'}, {'measure': 'Lung injury score(LIS)', 'timeFrame': 'From day 0 to day 7, day0,1,3,7', 'description': 'Murray lung injury scores (LIS) consist of the following 4 parts:\n\nA.Hypoxemia (PaO2/FiO2≥300, 225-299,175-224,100-174,\\<100, assigned 0,1,2,3,4 scores respectively); B.PEEP (cmH2O) (≤5,6-8,9-11,11-14,≥15, assigned 0,1,2,3,4 scores respectively) ; C.Compliance (ml/cmH2O)(≥80,60-79,40-59,20-39,≤19, assigned 0,1,2,3,4 scores respectively); D.Quadrants infiltrated in Chest X-Ray(CXR) (0,1,2,3,4, assigned 0,1,2,3,4 scores respectively).\n\nThe total LIS score is obtained by dividing the total sum of points by the number of criteria present. For example, if only 3 criteria are answered to, the total sum is divided by 3 to reveal the final score.\n\nThe LIS score ranges between 0 and 4, with scores closer to 4 indicating severe acute lung injury.'}, {'measure': 'Positive end expiratory pressure(PEEP)', 'timeFrame': 'From day 0 to day 7, each day', 'description': 'Monitored by ventilator and recorded per hour, obtain the average value of the day. unit-cmH20'}, {'measure': 'Plateau pressure(Pplat)', 'timeFrame': 'From day 0 to day 7, each day', 'description': 'Monitored by ventilator in one inspiration pause, measured 4 times a day. Record the average value of the day. unit-cmH20'}, {'measure': 'Driving pressure', 'timeFrame': 'From day 0 to day 7, each day', 'description': 'Calculate the driving pressure by Pplat minus PEEP, measured 4 times a day. Record the average value of the day. unit-cmH20'}, {'measure': 'Static compliance', 'timeFrame': 'From day 0 to day 7, each day', 'description': 'Calculate the static compliance by the following formula:\n\nstatic compliance=tidal volume/(Pplat-PEEP), unit-ml/cmH2O'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['refractory acuter respiratory distress syndrome', 'mesenchymal stem cells', 'salvage therapy'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'Acute respiratory distress syndrome (ARDS) is a devastating inflammatory and destructive disease in critical ill patients. Preclinical studies have shown a promising perspective of mesenchymal stem cells (MSCs) therapies in ARDS. But the safety and efficacy of umbilical cord MSCs (UCMSCs) have not yet been convinced in clinical trails. This study will explore the safety and life-rescue potential of UCMSCs in refracotry ARDS.', 'detailedDescription': 'This is a single arm study. According Berlin definition (2012), moderate or severe adult ARDS patients who fail to improve oxygenation (PaO2/FiO2 increase over 20%) in the first 24h or 8h after diagnosis will be enrolled. A salvage package of 10\\^6/kg suspended UCMSCs in 100ml normal saline or only 100ml normal saline will be infused through central venous catheter. Infusion associated events (IAEs) in 24 hours will be closely monitored. Compared with propensity score matched controls, mortality in 28 days as the primary outcomes. oxygenation index, ventilator parameters, lung injury biomarkers and clinical outcomes as secondary outcomes will be analyzed.\n\nThis is a revised trail from its previous registered pilot RCT, approved by Ethic Committe of Stem Cells Trails (ECSCT) of 3rd affiliated hospital of Sun Yat-Sen university'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged≥18 years old;\n2. Including all the criteria:\n\n(1) Invasive ventilation, OI（PaO2/FiO2）\\<200; (2) PEEP≥8cmH2O; (3) Bilateral infiltration of lung in X-ray or CT; (4) In 1 week after onset; (5) Still OI\\<200 after protective ventilation or conservative fluid management.\n\nExclusion Criteria:\n\n1. Any malignant disease;\n2. Cardiogenic pulmonary edema;\n3. Over 50% atelectasis either lung lobe in X-ray;\n4. Pregnancy or perinatal or lactation;\n5. Previous end stage respiratory disease;\n6. More than 3 organs failure;\n7. Liver failure with MELD(Model For End-Stage Liver Disease) score\\>40;\n8. Stage III or IV pulmonary hypertension;\n9. None invasive arterial and central venous catheter;\n10. Concurrent deep venous thrombus or pulmonary embolism in 3 months;\n11. Cerebral hernia;\n12. More than 96 hours after ARDS onset.'}, 'identificationModule': {'nctId': 'NCT03608592', 'acronym': 'ARDS', 'briefTitle': 'Human Umbilical Cord Mesenchymal Stem Cells (MSCs) Therapy in ARDS', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Human Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'QHJH201804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UCMSCs group', 'description': 'Intravenous infusion of 1million UCMSCs per kilogram body weight suspended in 100ml normal saline, infusion duration 30-60min.', 'interventionNames': ['Biological: umbilical cord derived mesenchymal stem cells (UCMSCs) suspension', 'Biological: normal saline']}], 'interventions': [{'name': 'umbilical cord derived mesenchymal stem cells (UCMSCs) suspension', 'type': 'BIOLOGICAL', 'description': 'Clinical grade human umbilical cord derived mesenchymal stem cells (passage 3-5) suspension are provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University. Cells are made of suspension packages (60million cells in 100ml normal saline per bag) and infused intravenously in 2 hours.', 'armGroupLabels': ['UCMSCs group']}, {'name': 'normal saline', 'type': 'BIOLOGICAL', 'description': 'A bag of 100ml clinical grade normal saline are also provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University.', 'armGroupLabels': ['UCMSCs group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haijin Lv', 'role': 'CONTACT', 'phone': '2082179173'}], 'facility': 'Huimin Yi', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Huimin Yi, Doctor', 'role': 'CONTACT', 'email': 'ylhmin@hotmail.com', 'phone': '86-020-85252673'}], 'overallOfficials': [{'name': 'Huimin Yi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The 3rd affiliated hospital of Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'attending physician', 'investigatorFullName': 'Lv Haijin', 'investigatorAffiliation': 'Sun Yat-sen University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-01-08', 'type': 'RELEASE'}, {'date': '2023-11-02', 'type': 'RESET'}, {'date': '2023-11-21', 'type': 'RELEASE'}, {'date': '2024-04-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Lv Haijin, attending physician, Sun Yat-sen University'}}}}