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

NCT ID: NCT04325594

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2023-04-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Patients with chronic non-ischemic heart failure received a single intracoronary administration of 1×10⁷ umbilical cord-derived MSCs and continued optimal pharmacological therapy.

Group Type: EXPERIMENTAL

Intracoronary administration of umbilical cord-derived MSCs

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Men and women aged 18 years and older
• Registered at the Research-Clinical Center for Cardiac Surgery and Transplantology
• Established diagnosis of non-ischemic dilated cardiomyopathy (NYHA Class III-IV)
• Non-ischemic etiology confirmed by coronary angiography or contrast-enhanced cardiac CT
• Left ventricular ejection fraction (LVEF) ≤ 35% based on echocardiography or cardiac CT
• Clinical indications for implantation of an implantable cardioverter-defibrillator (ICD), regardless of actual implantation status
• No clinical or laboratory signs of dysfunction or insufficiency of other major organs
• No history of malignancy within the past 5 years and no abnormal tumor markers
• Signed written informed consent

Exclusion Criteria

• Ischemic heart disease or prior cardiac surgery, including coronary artery stenting
• Significant valvular heart disease, intracardiac thrombus, left ventricular aneurysm, hypertrophic, postpartum, alcoholic or restrictive cardiomyopathy, congenital heart defects, or resistant hypertension
• Stroke within the past 2 years
• Autoimmune or immunodeficiency disorders
• Polyvalent allergy
• Decompensated chronic comorbidities
• Use of systemic corticosteroids, cytotoxic or immunosuppressive drugs (e.g., cyclophosphamide, methotrexate, cyclosporine, azathioprine) within 4 weeks before enrollment
• Positive tests for hepatitis B or C, syphilis, or HIV/AIDS
• Active systemic infections requiring targeted antibiotic therapy
• Untreated peptic ulcer disease or history of gastrointestinal bleeding
• Clinically significant traumatic brain injury requiring treatment
• Uncontrolled epileptic seizures
• Porphyria
• Requirement for hospice-level care
• Alcohol or drug abuse, lack of permanent residence, severe depression, disorientation, or inability to participate in follow-up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State-Financed Health Facility "Samara Regional Medical Center Dinasty"

OTHER

Sponsor Role: collaborator

The Research-Clinical Center for Cardiac Surgery and Transplantology LLP

OTHER

Sponsor Role: lead

Responsible Party

Azkhojayev Aziz, MD

Cardiac surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aziz Azkhojayev, MD

Role: PRINCIPAL_INVESTIGATOR

The Research-Clinical Center for Cardiac Surgery and Transplantology LLP

Locations

The Research-Clinical Center for Cardiac Surgery and Transplantology LLP

Taraz, Zhambyl Oblysy, Kazakhstan

Countries

Kazakhstan

Other Identifiers

RCCCT 02-02-2020

Identifier Type: -

Identifier Source: org_study_id