Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-25 @ 5:44 PM
Study NCT ID:
NCT03902067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2019-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UC-MSC Transplantation for Left Ventricular Dysfunction After AMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2019-03-28', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety measured as the number of Major Adverse Cardiac Events (MACE)', 'timeFrame': '12 months', 'description': 'Possible adverse events, including adverse events that may occur during angiography and infusion of transplanted cells such as chest pain, arrhythmia, slow blood flow, myocardial injury, fever, allergic reaction, postoperative infection, etc.'}], 'secondaryOutcomes': [{'measure': 'Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up', 'timeFrame': '12 months', 'description': 'left ventricular ejection fraction measured by magnetic resonance imaging'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AMI'], 'conditions': ['Left Ventricular Dysfunction', 'Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation', 'detailedDescription': 'In this study, 40 patients with cardiac insufficiency after acute myocardial infarction were selected and randomly divided into umbilical cord MSCs transplantation treatment group and non-intervention control group to preliminarily observe the safety and effectiveness of MSCs cell transplantation treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute extensive anterior myocardial infarction were successfully treated with emergency interventional therapy within 12 hours after onset. LVEF was less than 0.35 by echocardiography 30 days after operation, scar area was more than 25% by MRI, and cardiac function was NYHA III-IV grade.\n* Fully inform the purpose, method and possible side effects of the test, agree to the test, and sign an informed consent form;\n* Good compliance, willing to take drugs and follow up according to the requirements of the plan;\n* Life expectancy exceeds one year.\n\nExclusion Criteria:\n\n* Those who cannot tolerate cell therapy;\n* Patients with severe hepatic and renal insufficiency (ALT\\>1.5 times the upper limit of normal value, Cr \\>1.5 times the upper limit of normal value);\n* Patients with malignant tumors or extremely weak patients;\n* Patients with severe infection;\n* Patients who are expected to have the second coronary intervention or bypass grafting within 3 months;\n* Patients with other serious systemic diseases and organ dysfunction;\n* Patients with cardiogenic shock;\n* Patients with hemorrhagic diseases;\n* Researchers believe that anyone who is not suitable for inclusion'}, 'identificationModule': {'nctId': 'NCT03902067', 'briefTitle': 'UC-MSC Transplantation for Left Ventricular Dysfunction After AMI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Life Science & Technology'}, 'officialTitle': 'Safety and Efficacy Evaluation of Umbilical Cord Mesenchymal Stem Cells Transcatheter Transplantation to Treat Left Ventricular Dysfunction After Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'ShanghaiLST-ucmsc-ami01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UC-MSC', 'description': 'UC-MSC transplantation', 'interventionNames': ['Biological: UC-MSC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Routine treatment', 'interventionNames': ['Biological: Control Group']}], 'interventions': [{'name': 'UC-MSC', 'type': 'BIOLOGICAL', 'otherNames': ['Transplantation Group'], 'description': '0.25ml Shanghai Life UC-MSC injection is resuspended into 10ml of cell suspension and slowly infused into infarct-related blood vessels through an administration catheter in 2 minutes, and the number of cells transplanted each time is 5x10(6) cells. The UC-MSC products are manufactured by Shanghai Life with viability\\>80%, and endotoxin\\<0.1 EU， at the concentration of 2x10(7) cells/ml.', 'armGroupLabels': ['UC-MSC']}, {'name': 'Control Group', 'type': 'BIOLOGICAL', 'description': 'Routine treatment without catheter infusion', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200233', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Chengxing Shen', 'role': 'CONTACT', 'email': 'shencx@sjtu.edu.cn', 'phone': '+86-18501664545'}], 'facility': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Chengxing Shen', 'role': 'CONTACT', 'email': 'shencx@sjtu.edu.cn', 'phone': '+86-18501664545'}, {'name': 'Gang LU', 'role': 'CONTACT', 'email': 'glu@shlifestemcell.com', 'phone': '+862134712825'}], 'overallOfficials': [{'name': 'Chengxing Shen, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Life Science & Technology', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Shanghai Jiao Tong University Affiliated Sixth People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}