Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT03180450
Status:
SUSPENDED
Last Update Posted:
2025-05-14
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'Others', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart color ultrasound evaluation', 'timeFrame': '12 months', 'description': 'Criteria:\n\n* Excellent: ejection fraction improve to \\> 50%;\n* Efficient: ejection fraction improved;\n* Inefficient: ejection fraction same as before treatment;\n* Exacerbation: ejection fraction declined.'}], 'secondaryOutcomes': [{'measure': 'Single therapy effectiveness evaluation', 'timeFrame': '12 months', 'description': 'Evaluate criteria:\n\n* Recovery: symptoms disappear\n* Excellent: symptoms improved obviously\n* Efficient: symptoms improved\n* Inefficient: symptoms no change or worse'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Human Umbilical Cord Mesenchymal Stem Cells'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients', 'detailedDescription': 'This is a randomized, paralleled study. Patients will be divided into two groups of treatment and control. all of them will receive conventional treatment based on specific condition, including digitalis, milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), and antiplatelet aggregation etc. Treatment group patients will receive hUC-MSC. Follow-up visit will occur on 3 months, 6 months, and 12 months after the cell transfusion. Vital signs, blood routine test, urine routine test, liver function examination, etc, will be placed to evaluate the safety of hUC-MSC treatment. And the change of symptoms to evaluate the efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* volunteer to participate in clinical trial, and sign informed consent form\n* with cardiac failure symptoms, including oppression in chest, breathe hard, lower limb edema. And new york heart association class as two to four\n* heart color ultrasound indicate left ventricular ejection fraction (LVEF) \\< 40%\n* content of serum NT-proBNP \\> 450pg/ml\n\nExclusion Criteria:\n\n* with severe drug allergy history or allergic constitution\n* patients were severe infected\n* with malignant tumor or with high tumor marker\n* with severe cardiorespiratory dysfunction, hematological system disease\n* with severe mental disorder, cognitive impairment\n* with persistent atrial fibrillation, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy or restrictive cardiomyopathy patients\n* end-stage renal insufficiency, pregnancy, or breast feeding women\n* bleeding tendency, active gastrointestinal ulcer\n* recent have major surgery, stroke, cancer, hepatic function insufficiency or other life-threatening condition.\n* under other therapy that possibly influence MSC security or efficacy\n* donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive\n* participant/donor: alcoholism, drug addicted, mental disease'}, 'identificationModule': {'nctId': 'NCT03180450', 'briefTitle': 'The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sclnow Biotechnology Co., Ltd.'}, 'officialTitle': 'The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)', 'orgStudyIdInfo': {'id': 'SCLnow-IMIMH-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v.', 'interventionNames': ['Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)', 'Drug: conventional treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Conventional treatment', 'interventionNames': ['Drug: conventional treatment']}], 'interventions': [{'name': 'Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)', 'type': 'BIOLOGICAL', 'description': 'Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation.', 'armGroupLabels': ['Treatment group']}, {'name': 'conventional treatment', 'type': 'DRUG', 'description': "The drug and usage will be determined based on patient's condition, including milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), or antiplatelet aggregation etc.", 'armGroupLabels': ['Control group', 'Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '010065', 'city': 'Hohhot', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Inner Mongolia International Mongolian Hospital', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}], 'overallOfficials': [{'name': 'Nashundalai', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inner Mongolia International Mongolian Hospital'}, {'name': 'Lei Guo, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'China-Japan Union Hospital, Jilin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sclnow Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}