Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-31 @ 7:01 AM
Study NCT ID:
NCT01273857
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2011-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018636', 'term': 'Hypoplastic Left Heart Syndrome'}, {'id': 'D000080039', 'term': 'Univentricular Heart'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hidemasa@md.okayama-u.ac.jp', 'phone': '+81-086-235-6506', 'title': 'Prof. Hidemasa Oh', 'organization': 'Okayama University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 years', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Subjects will undergo standard staged-procedures without cell infusion\n\nstaged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cell Infusion', 'description': 'Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure\n\nAutologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.\n\nstaged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects will undergo standard staged-procedures without cell infusion\n\nstaged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied'}, {'id': 'OG001', 'title': 'Cell Infusion', 'description': 'Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure\n\nAutologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.\n\nstaged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months to 1 year after cell transplantation', 'description': 'Feasibility was assessed by number of participants discontinued the study due to adverse events or number of participants received unsuccessful cell delivery by study physician. Unsuccessful was defined as failure of coronary selection of guiding catheter or direct cell infusion.\n\nThe primary end point is to monitor major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects will undergo standard staged-procedures without cell infusion\n\nstaged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied'}, {'id': 'OG001', 'title': 'Cell Infusion', 'description': 'Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure\n\nAutologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.\n\nstaged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months to 1 year after cell transplantation', 'description': 'The incidence of hospitalization for heart failure, ventricular arrhythmia, general infection, and renal and hepatic dysfunction by CDC treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Subjects will undergo standard staged-procedures without cell infusion\n\nstaged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied'}, {'id': 'FG001', 'title': 'Cell Infusion', 'description': 'Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure\n\nAutologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.\n\nstaged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Subjects will undergo standard staged-procedures without cell infusion\n\nstaged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied'}, {'id': 'BG001', 'title': 'Cell Infusion', 'description': 'Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure\n\nAutologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.\n\nstaged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2011-01-10', 'resultsFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2011-01-10', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-12', 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells', 'timeFrame': '3 months to 1 year after cell transplantation', 'description': 'Feasibility was assessed by number of participants discontinued the study due to adverse events or number of participants received unsuccessful cell delivery by study physician. Unsuccessful was defined as failure of coronary selection of guiding catheter or direct cell infusion.\n\nThe primary end point is to monitor major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.'}], 'secondaryOutcomes': [{'measure': 'Serious Adverse Events', 'timeFrame': '3 months to 1 year after cell transplantation', 'description': 'The incidence of hospitalization for heart failure, ventricular arrhythmia, general infection, and renal and hepatic dysfunction by CDC treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac progenitor cells', 'Cell therapy', 'Hypoplastic Left Heart Syndrome', 'Single Ventricle', 'Norwood', 'Sano modification', 'Glenn', 'Fontan'], 'conditions': ['Hypoplastic Left Heart Syndrome', 'Single Ventricle', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '19038683', 'type': 'BACKGROUND', 'citation': 'Takehara N, Tsutsumi Y, Tateishi K, Ogata T, Tanaka H, Ueyama T, Takahashi T, Takamatsu T, Fukushima M, Komeda M, Yamagishi M, Yaku H, Tabata Y, Matsubara H, Oh H. Controlled delivery of basic fibroblast growth factor promotes human cardiosphere-derived cell engraftment to enhance cardiac repair for chronic myocardial infarction. J Am Coll Cardiol. 2008 Dec 2;52(23):1858-1865. doi: 10.1016/j.jacc.2008.06.052.'}, {'pmid': '18754813', 'type': 'BACKGROUND', 'citation': 'Tateishi K, Takehara N, Matsubara H, Oh H. Stemming heart failure with cardiac- or reprogrammed-stem cells. J Cell Mol Med. 2008 Dec;12(6A):2217-32. doi: 10.1111/j.1582-4934.2008.00487.x. Epub 2008 Aug 27.'}, {'pmid': '17502484', 'type': 'BACKGROUND', 'citation': 'Tateishi K, Ashihara E, Takehara N, Nomura T, Honsho S, Nakagami T, Morikawa S, Takahashi T, Ueyama T, Matsubara H, Oh H. Clonally amplified cardiac stem cells are regulated by Sca-1 signaling for efficient cardiovascular regeneration. J Cell Sci. 2007 May 15;120(Pt 10):1791-800. doi: 10.1242/jcs.006122.'}, {'pmid': '17150190', 'type': 'BACKGROUND', 'citation': 'Tateishi K, Ashihara E, Honsho S, Takehara N, Nomura T, Takahashi T, Ueyama T, Yamagishi M, Yaku H, Matsubara H, Oh H. Human cardiac stem cells exhibit mesenchymal features and are maintained through Akt/GSK-3beta signaling. Biochem Biophys Res Commun. 2007 Jan 19;352(3):635-41. doi: 10.1016/j.bbrc.2006.11.096. Epub 2006 Nov 27.'}, {'pmid': '25403163', 'type': 'RESULT', 'citation': 'Ishigami S, Ohtsuki S, Tarui S, Ousaka D, Eitoku T, Kondo M, Okuyama M, Kobayashi J, Baba K, Arai S, Kawabata T, Yoshizumi K, Tateishi A, Kuroko Y, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome: the TICAP prospective phase 1 controlled trial. Circ Res. 2015 Feb 13;116(4):653-64. doi: 10.1161/CIRCRESAHA.116.304671. Epub 2014 Nov 17.'}, {'pmid': '39526355', 'type': 'DERIVED', 'citation': 'Hirai K, Sawada R, Hayashi T, Araki T, Nakagawa N, Kondo M, Yasuda K, Hirata T, Sato T, Nakatsuka Y, Yoshida M, Kasahara S, Baba K, Oh H; TICAP/PERSEUS Study Group. Eight-Year Outcomes of Cardiosphere-Derived Cells in Single Ventricle Congenital Heart Disease. J Am Heart Assoc. 2024 Nov 19;13(22):e038137. doi: 10.1161/JAHA.124.038137. Epub 2024 Nov 11.'}, {'pmid': '29367212', 'type': 'DERIVED', 'citation': 'Sano T, Ousaka D, Goto T, Ishigami S, Hirai K, Kasahara S, Ohtsuki S, Sano S, Oh H. Impact of Cardiac Progenitor Cells on Heart Failure and Survival in Single Ventricle Congenital Heart Disease. Circ Res. 2018 Mar 30;122(7):994-1005. doi: 10.1161/CIRCRESAHA.117.312311. Epub 2018 Jan 24.'}, {'pmid': '26232942', 'type': 'DERIVED', 'citation': 'Tarui S, Ishigami S, Ousaka D, Kasahara S, Ohtsuki S, Sano S, Oh H. Transcoronary infusion of cardiac progenitor cells in hypoplastic left heart syndrome: Three-year follow-up of the Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single-Ventricle Physiology (TICAP) trial. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1198-1207, 1208.e1-2. doi: 10.1016/j.jtcvs.2015.06.076. Epub 2015 Jul 8.'}]}, 'descriptionModule': {'briefSummary': "Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac output. Infants with the syndrome generally undergo a staged surgical approach in view of an ultimate Fontan procedure. Although long-term survival in patients with HLHS and related single ventricle physiology has improved markedly with advances in medical and surgical therapies, a growing number of infants will ultimately require heart transplantation for end-stage heart failure due to several potential disadvantages include a negative effect on right ventricular function, arrhythmia, additional volume load via regurgitation from the nonvalved shunt, and impaired growth of the pulmonary artery.\n\nRisk factors for poor outcome of heart transplantation with HLHS and single ventricle physiology are older age at transplantation and previous Fontan operation. New strategies are needed to improve the underlying transplant risks proper for the Fontan failure patients.\n\nEmerging evidence suggests that heart-derived stem/progenitor cells can be used to improved cardiac function in patients with ischemic heart disease. In this trial, the investigators aimed to test the safety and feasibility of intracoronary injection of autologous cardiac progenitor cells in patients with HLHS and related single ventricle anomalies and that could improve ventricular function at 3 months' follow up.", 'detailedDescription': "Autologous cardiac progenitor cells are isolated from patients' own cardiac tissues obtained during palliative shunt procedure. Patients will receive 0.3 million/kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants with hypoplastic left heart syndrome and related single ventricle anomalies undergoing first to third palliative shunt surgeries will be recruited into the study.\n* Patients between 0 and 6 years of age are eligible if written informed consent can be obtained.\n\nExclusion Criteria:\n\n* Cardiogenic shock\n* Eisenmenger syndrome\n* Uncontrollable arrhythmia\n* Severe chronic diseases\n* Infections\n* Cancer\n* Unwillingness to participate'}, 'identificationModule': {'nctId': 'NCT01273857', 'acronym': 'TICAP', 'briefTitle': 'Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology', 'organization': {'class': 'OTHER', 'fullName': 'Okayama University'}, 'officialTitle': 'Phase I Study of Cardiac Progenitor Cell Therapy in Patients With Single Ventricle Physiology', 'orgStudyIdInfo': {'id': 'MHLW10103228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Subjects will undergo standard staged-procedures without cell infusion', 'interventionNames': ['Procedure: staged shunt procedure']}, {'type': 'EXPERIMENTAL', 'label': 'Cell infusion', 'description': 'Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure', 'interventionNames': ['Procedure: Autologous cardiac progenitor cell transplantation', 'Procedure: staged shunt procedure']}], 'interventions': [{'name': 'Autologous cardiac progenitor cell transplantation', 'type': 'PROCEDURE', 'otherNames': ['Cardiosphere-derived cells'], 'description': 'Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.', 'armGroupLabels': ['Cell infusion']}, {'name': 'staged shunt procedure', 'type': 'PROCEDURE', 'description': 'Norwood-Glenn, Glenn, or Fontan procedure will be applied', 'armGroupLabels': ['Cell infusion', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-8558', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}], 'overallOfficials': [{'name': 'Hidemasa Oh, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okayama University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cerebral and Cardiovascular Center, Japan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD., Ph.D.', 'investigatorFullName': 'Hidemasa Oh, MD', 'investigatorAffiliation': 'Okayama University'}}}}