Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 1:45 AM
Study NCT ID:
NCT04325594
Status:
COMPLETED
Last Update Posted:
2025-04-20
First Post:
2020-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-ischemic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of ischemic and arrhythmic events, abnormal laboratory and ECG findings within 5 days after intracoronary infusion of umbilical cord-derived MSCs [Safety Assessment]', 'timeFrame': 'First 5 days after infusion', 'description': 'Safety will be assessed during a 5-day hospitalization period. Cardiac monitoring will be performed during and after intracoronary MSC infusion. Assessment includes incidence of ECG changes (e.g., ST-segment deviation), cardiac enzyme elevations (AST, ALT), local hypokinesia by echocardiography, and occurrence of ventricular arrhythmias. Laboratory evaluations include complete blood count, biochemistry, coagulation, and urinalysis on day 1 and day 5. Immune status will be assessed via neutrophil count and activity. Patients will be monitored in the intensive care unit for the first 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Change in left ventricular structure and function', 'timeFrame': '1, 3, and 6 months', 'description': 'Changes in left ventricular ejection fraction (LVEF), end-diastolic and end-systolic volumes (EDV/ESV), and end-diastolic and end-systolic diameters (EDD/ESD), assessed by transthoracic echocardiography and cardiac computed tomography.'}, {'measure': 'Change in NT-proBNP levels', 'timeFrame': '1, 3, and 6 months', 'description': 'Serum levels of NT-proBNP as a biomarker of myocardial dysfunction.'}, {'measure': 'Change in 6-minute walk test distance', 'timeFrame': '1, 3, and 6 months', 'description': 'Functional capacity evaluated by the distance covered in the 6-minute walk test.'}, {'measure': 'Change in NYHA functional class', 'timeFrame': '1, 3, and 6 months', 'description': 'Heart failure severity graded by the New York Heart Association classification.'}, {'measure': 'Change in quality of life', 'timeFrame': '1, 3, and 6 months', 'description': 'Quality of life assessed using the SF-12 Health Survey, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Minnesota Living with Heart Failure Questionnaire (MLHFQ).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic heart failure', 'Non-ischemic Cardiomyopathy', 'Non-ischemic Dilated Cardiomyopathy', 'Mesenchymal stromal cells', 'Umbilical cord', 'Regenerative Medicine'], 'conditions': ['Chronic Heart Failure', 'Non-ischemic Cardiomyopathy', 'Non-ischemic Dilated Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective single-arm clinical study was to evaluate the safety and potential efficacy of intracoronary administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSCs) as an addition to standard medical therapy in patients with chronic non-ischemic heart failure.', 'detailedDescription': 'This prospective, open-label, single-arm clinical trial investigated the safety and potential efficacy of intracoronary administration of allogeneic umbilical cord-derived mesenchymal stromal cells (MSCs) in patients with chronic non-ischemic heart failure.\n\nA total of 30 patients were enrolled. All participants received standard pharmacological therapy and underwent a single intracoronary infusion of 1×10⁷ MSCs delivered into the left coronary artery during routine cardiac catheterization. The primary objective was to assess the safety of the cell therapy over the first 5 days of hospitalization. Secondary outcomes included changes in left ventricular ejection fraction (LVEF), end-diastolic and end-systolic volumes and diameters, serum NT-proBNP levels, NYHA functional class, 6-minute walk test distance, and quality of life indicators (SF-12, KCCQ, MLHFQ) at 1, 3, and 6 months post-infusion.\n\nAlthough the study was originally registered with a control group and randomization, it was ultimately conducted as a single-arm design due to ethical and logistical constraints in recruitment. All patients received the same intervention, and no allocation or randomization was performed.\n\nWhile most patients had clinical indications for an implantable cardioverter-defibrillator (ICD) in accordance with international guidelines, not all had the device implanted due to personal refusal of the procedure. Therefore, ICD presence was not required for inclusion in the study.\n\nAlthough remuscularization of the myocardium was not a predefined endpoint, retrospective analysis revealed post-treatment thickening of the left ventricular posterior wall and interventricular septum in a subset of patients, as observed on cardiac computed tomography. This structural change was associated with improved systolic function and may guide future hypothesis-driven research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 years and older\n* Registered at the Research-Clinical Center for Cardiac Surgery and Transplantology\n* Established diagnosis of non-ischemic dilated cardiomyopathy (NYHA Class III-IV)\n* Non-ischemic etiology confirmed by coronary angiography or contrast-enhanced cardiac CT\n* Left ventricular ejection fraction (LVEF) ≤ 35% based on echocardiography or cardiac CT\n* Clinical indications for implantation of an implantable cardioverter-defibrillator (ICD), regardless of actual implantation status\n* No clinical or laboratory signs of dysfunction or insufficiency of other major organs\n* No history of malignancy within the past 5 years and no abnormal tumor markers\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Ischemic heart disease or prior cardiac surgery, including coronary artery stenting\n* Significant valvular heart disease, intracardiac thrombus, left ventricular aneurysm, hypertrophic, postpartum, alcoholic or restrictive cardiomyopathy, congenital heart defects, or resistant hypertension\n* Stroke within the past 2 years\n* Autoimmune or immunodeficiency disorders\n* Polyvalent allergy\n* Decompensated chronic comorbidities\n* Use of systemic corticosteroids, cytotoxic or immunosuppressive drugs (e.g., cyclophosphamide, methotrexate, cyclosporine, azathioprine) within 4 weeks before enrollment\n* Positive tests for hepatitis B or C, syphilis, or HIV/AIDS\n* Active systemic infections requiring targeted antibiotic therapy\n* Untreated peptic ulcer disease or history of gastrointestinal bleeding\n* Clinically significant traumatic brain injury requiring treatment\n* Uncontrolled epileptic seizures\n* Porphyria\n* Requirement for hospice-level care\n* Alcohol or drug abuse, lack of permanent residence, severe depression, disorientation, or inability to participate in follow-up'}, 'identificationModule': {'nctId': 'NCT04325594', 'acronym': 'RegenHeart', 'briefTitle': 'The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-ischemic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'The Research-Clinical Center for Cardiac Surgery and Transplantology LLP'}, 'officialTitle': 'Optimization of the Complex Treatment of Nonischemic Dilated Cardiomyopathy Due to the Addition to the Standard Drug Therapy of Intracoronary Administration of Umbilical Cord-derived Mesenchymal Stromal Cells', 'orgStudyIdInfo': {'id': 'RCCCT 02-02-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Patients with chronic non-ischemic heart failure received a single intracoronary administration of 1×10⁷ umbilical cord-derived MSCs and continued optimal pharmacological therapy.', 'interventionNames': ['Biological: Intracoronary administration of umbilical cord-derived MSCs']}], 'interventions': [{'name': 'Intracoronary administration of umbilical cord-derived MSCs', 'type': 'BIOLOGICAL', 'description': 'A suspension of 1×10⁷ umbilical cord-derived mesenchymal stromal cells in 20 ml of heparinized saline was administered by intracoronary infusion into the left coronary artery via a standard 6 Fr catheter over 10 minutes (2 ml/min). The infusion was performed without balloon occlusion or interruption of coronary blood flow.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '080000', 'city': 'Taraz', 'state': 'Zhambyl Oblysy', 'country': 'Kazakhstan', 'facility': 'The Research-Clinical Center for Cardiac Surgery and Transplantology LLP', 'geoPoint': {'lat': 42.89799, 'lon': 71.37334}}], 'overallOfficials': [{'name': 'Aziz Azkhojayev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Research-Clinical Center for Cardiac Surgery and Transplantology LLP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Research-Clinical Center for Cardiac Surgery and Transplantology LLP', 'class': 'OTHER'}, 'collaborators': [{'name': 'State-Financed Health Facility "Samara Regional Medical Center Dinasty"', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiac surgeon', 'investigatorFullName': 'Azkhojayev Aziz, MD', 'investigatorAffiliation': 'The Research-Clinical Center for Cardiac Surgery and Transplantology LLP'}}}}