NCT04325594

The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-ischemic Heart Failure

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The Research-Clinical Center for Cardiac Surgery and Transplantology LLP · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Heart Failure
• Non-ischemic Cardiomyopathy
• Non-ischemic Dilated Cardiomyopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-03-01
• Primary completion: 2023-01-01
• Completion: 2023-04-01
• First posted: 2020-03-27
• Last updated: 2025-04-20

Locations

1 site across 1 country: Kazakhstan