A Phase 1/2 interventional study of Intracoronary administration of umbilical cord-derived MSCs in Chronic Heart Failure, Non-ischemic Cardiomyopathy and Non-ischemic Dilated Cardiomyopathy, sponsored by The Research-Clinical Center for Cardiac Surgery and Transplantology LLP. Completed at 1 site in Kazakhstan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by The Research-Clinical Center for Cardiac Surgery and Transplantology LLP · Phase 1/2, Interventional, and Treatment
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.
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.
A 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.
Although 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.
While 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.
Although 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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
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Exclusion Criteria:
Patients with chronic non-ischemic heart failure received a single intracoronary administration of 1×10⁷ umbilical cord-derived MSCs and continued optimal pharmacological therapy.
Biological: Intracoronary administration of umbilical cord-derived MSCs
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.
Incidence of ischemic and arrhythmic events, abnormal laboratory and ECG findings within 5 days after intracoronary infusion of umbilical cord-derived MSCs [Safety Assessment]
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.
Time frame: First 5 days after infusion
Change in left ventricular structure and function
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.
Time frame: 1, 3, and 6 months
Change in NT-proBNP levels
Serum levels of NT-proBNP as a biomarker of myocardial dysfunction.
Time frame: 1, 3, and 6 months
Change in 6-minute walk test distance
Functional capacity evaluated by the distance covered in the 6-minute walk test.
Time frame: 1, 3, and 6 months
Change in NYHA functional class
Heart failure severity graded by the New York Heart Association classification.
Time frame: 1, 3, and 6 months
Change in quality of life
Quality of life assessed using the SF-12 Health Survey, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Time frame: 1, 3, and 6 months
Plan to share: No
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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