Status:
COMPLETED
The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-ischemic Heart Failure
Lead Sponsor:
The Research-Clinical Center for Cardiac Surgery and Transplantology LLP
Collaborating Sponsors:
State-Financed Health Facility "Samara Regional Medical Center Dinasty"
Conditions:
Chronic Heart Failure
Non-ischemic Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 cel...
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 (M...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04325594
Start Date
March 1 2020
End Date
April 1 2023
Last Update
April 20 2025
Active Locations (1)
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1
The Research-Clinical Center for Cardiac Surgery and Transplantology LLP
Taraz, Zhambyl Oblysy, Kazakhstan, 080000