CompletedPhase 1/2

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

Kazakhstan30 participantsStarted 2020-03-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Unt…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of ischemic and arrhythmic events, abnormal laboratory and ECG findings within 5 days after intracoronary infusion of umbilical cord-derived MSCs [Safety Assessment]

Timeframe: First 5 days after infusion

Trial details

NCT IDNCT04325594

SponsorThe Research-Clinical Center for Cardiac Surgery and Transplantology LLP

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-01

View on ClinicalTrials.gov More Chronic Heart Failure trials