Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT03759405
Status:
UNKNOWN
Last Update Posted:
2022-07-22
First Post:
2018-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2018-11-23', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life assessment', 'timeFrame': '6 months', 'description': 'Minnesota Heart Failure Scale for Quality of Life. Scale ranges (0-100), do higher values represent a worse outcome. The higher the score, the lower the quality of life.'}, {'measure': 'Curative effect evaluation', 'timeFrame': '6 months', 'description': 'Cardiac Function Measurement by Cardiac Color Doppler Ultrasound. Under normal conditions, left ventricular ejection fraction is more than 50%. The lower ejection fraction, the worse heart function.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'Based on the safety evaluation of primates, the best cell transplantation scheme was integrated. One patient with CHF caused by coronary heart disease, one patient with CHF caused by dilatation and one patient with CHF caused by Keshan disease were selected and treated with autologous iPS differentiated cardiomyocyte intravenous transplantation. The safety evaluation of human body was completed and combined with subjective and objective indexes respectively. Structural and functional indicators were used to evaluate the therapeutic effect of cell transplantation. The results of animal experiments confirmed the safety and effectiveness of intravenous myocardial cell transplantation, and clarified its possible mechanism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* It accords with the diagnostic standard of chronic heart failure.\n* The etiological diagnosis accords with the corresponding diagnostic standard.\n* The age is 30\\~80 years old.\n* Cardiac function classification is III- grade IV.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Those who did not meet the diagnostic criteria and were included in the standard.\n* Patients with severe dyspnea (such as COPD with pulmonary encephalopathy, upper gastrointestinal bleeding, etc.) accompanied by obvious hypoxemia and hemodynamic instability.\n* Patients with severe primary diseases, such as liver and kidney diseases, hematological diseases, autoimmune diseases, malignant tumors, progressive diseases or diseases with poor prognosis, such as severe infection, severe water and electrolyte disorders, acid-base imbalance.\n* Various infectious diseases.\n* Participants in other clinical trials in the past two months.'}, 'identificationModule': {'nctId': 'NCT03759405', 'acronym': 'IDCVTCHF', 'briefTitle': 'IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Beijing University of Chinese Medicine'}, 'officialTitle': 'Myocardial Cell Vein Transplantation for Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'BUCM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chronic heart failure treatment group', 'description': 'One case of CHF caused by coronary heart disease, one case of CHF caused by dilated heart disease and one case of CHF caused by Keshan disease were selected and treated with autologous iPS differentiated cardiomyocyte intravenous transplantation.', 'interventionNames': ['Biological: iPS differentiated cardiomyocytes']}], 'interventions': [{'name': 'iPS differentiated cardiomyocytes', 'type': 'BIOLOGICAL', 'description': 'Repair of injured myocardium by vein transplantation with autologous iPS differentiated cardiomyocytes', 'armGroupLabels': ['Chronic heart failure treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing University of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing University of Chinese Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dongzhimen Hospital, Beijing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Anlong Xu', 'investigatorAffiliation': 'Beijing University of Chinese Medicine'}}}}