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

NCT04325594 | Completed Phase 1

• 1 other identifier: RCCCT 02-02-2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chronic heart failure; Non-ischemic Cardiomyopathy; Non-ischemic Dilated Cardiomyopathy; Mesenchymal stromal cells; Umbilical cord; Regenerative Medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  First 5 days after infusion

Secondary Outcomes (5)

• Change in left ventricular structure and function

  1, 3, and 6 months

• Change in NT-proBNP levels

  1, 3, and 6 months

• Change in 6-minute walk test distance

  1, 3, and 6 months

• Change in NYHA functional class

  1, 3, and 6 months

• Change in quality of life

  1, 3, and 6 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Interventions

Intracoronary administration of umbilical cord-derived MSCs 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.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Research-Clinical Center for Cardiac Surgery and Transplantology LLP: lead
• State-Financed Health Facility "Samara Regional Medical Center Dinasty": collaborator

Study Sites (1)

The Research-Clinical Center for Cardiac Surgery and Transplantology LLP

Taraz, Zhambyl Oblysy, 080000, Kazakhstan

Location

Study Officials

• Aziz Azkhojayev, MD

  The Research-Clinical Center for Cardiac Surgery and Transplantology LLP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac surgeon

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 27, 2020
• Study Start: March 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)