Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04945018
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2021-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': '26 weeks post-transplant', 'description': 'Adverse events and safety in the 26 weeks after HS-001 CS transplantation'}], 'secondaryOutcomes': [{'measure': 'Left Ventricular Ejection Fraction in Cardiac MRI scan & Echocardiography', 'timeFrame': '26 weeks and 52 weeks post-transplant', 'description': 'Left Ventricular Ejection Fraction in the 26 weeks and 52 weeks after HS-001 CS transplantation'}, {'measure': 'Myocardial wall motion evaluation in Echocardiography', 'timeFrame': '26 weeks and 52 weeks post-transplant', 'description': 'Myocardial wall motion evaluation (Index of myocardial strain) in the 26 weeks and 52 weeks after HS-001 CS transplantation'}, {'measure': 'Myocardial blood flow in SPECT', 'timeFrame': '26 weeks and 52 weeks post-transplant', 'description': 'Myocardial blood flow in the 26 weeks and 52 weeks after HS-001 CS transplantation'}, {'measure': 'Myocardial viability in SPECT', 'timeFrame': '26 weeks and 52 weeks post-transplant', 'description': 'Myocardial viability in the 26 weeks and 52 weeks after HS-001 CS transplantation'}, {'measure': '6-minute walk distance', 'timeFrame': '26 weeks and 52 weeks post-transplant', 'description': '6-minute walk distance in the 26 weeks and 52 weeks after HS-001 CS transplantation'}, {'measure': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': '26 weeks and 52 weeks post-transplant', 'description': 'Kansas City Cardiomyopathy Questionnaire in the 26 weeks and 52 weeks after HS-001 CS transplantation'}, {'measure': '5-level EQ-5D version (EQ-5D-5L)', 'timeFrame': '26 weeks and 52 weeks post-transplant', 'description': '5-level EQ-5D version (EQ-5D-5L) in the 26 weeks and 52 weeks after HS-001 CS transplantation'}, {'measure': 'N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)', 'timeFrame': '26 weeks and 52 weeks post-transplant', 'description': 'N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in the 26 weeks and 52 weeks after HS-001 CS transplantation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Ischemic Heart Disease'], 'conditions': ['Heart Failure', 'Ischemic Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to evaluate the safety and efficacy of HS-001 CS transplanted into severe heart failure patients with underlying ischemic heart disease for 26 weeks after transplantation.', 'detailedDescription': 'This is a multicenter, open-label, two-group dose-escalation, phase I/II study in 10 severe heart failure patients (five in the low-dose group and five in the high-dose group) with underlying ischemic heart disease.\n\nAfter screening period is completed, subjects undergo HS-001 CS transplantation. After transplantation, subjects take immunosuppressant and have efficacy/safety assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with resting left ventricular ejection fraction (LVEF) ≦40% based on institutional assessment on either screening cardiac MRI or echocardiographic assessment\n* New York Heart Association (NYHA) cardiac function classification of grade II or higher at screening\n* Other Criteria apply, please contact the investigator\n\nExclusion Criteria:\n\n* Patients screened less than 1 month after the onset of myocardial infarction\n* Patients with congenital heart disease, or cardiac sarcoidosis\n* Other Criteria apply, please contact the investigator'}, 'identificationModule': {'nctId': 'NCT04945018', 'acronym': 'LAPiS', 'briefTitle': 'A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heartseed Inc.'}, 'officialTitle': 'A Phase I/II Study of Human Induced Pluripotent Stem (iPS) Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Severe Heart Failure, Secondary to Ischemic Heart Disease', 'orgStudyIdInfo': {'id': 'HS-001-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HS-001 Low dose', 'description': 'HS-001 Low dose Administration', 'interventionNames': ['Biological: HS-001 CS', 'Device: HS-001-D needle, HS-001-D Adaptor']}, {'type': 'EXPERIMENTAL', 'label': 'HS-001 High dose', 'description': 'HS-001 High dose Administration', 'interventionNames': ['Biological: HS-001 CS', 'Device: HS-001-D needle, HS-001-D Adaptor']}], 'interventions': [{'name': 'HS-001 CS', 'type': 'BIOLOGICAL', 'description': 'Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension', 'armGroupLabels': ['HS-001 High dose', 'HS-001 Low dose']}, {'name': 'HS-001-D needle, HS-001-D Adaptor', 'type': 'DEVICE', 'description': 'Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors', 'armGroupLabels': ['HS-001 High dose', 'HS-001 Low dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kawasaki', 'country': 'Japan', 'facility': 'St. Marianna University Hospital', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical University International Medical Center', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Juntendo University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Nihon University Itabashi Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'The University of Tokyo Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical and Dental University Medical Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Metropolitan Geriatric Medical Center', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': "Tokyo Women's Medical University", 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heartseed Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}