The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-isch… (NCT04325594) | Clinical Trial Compass
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 range18 Years
SexALL
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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…
What they're measuring
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]
Timeframe: First 5 days after infusion
Trial details
NCT IDNCT04325594
SponsorThe Research-Clinical Center for Cardiac Surgery and Transplantology LLP