RecruitingPhase 2NCT06154044

Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support

The Effects of Cell Therapy on Myocardial Recovery in Chronic Heart Failure Patients Undergoing Left Ventricular Assist Device Support: A Pilot Trial (CELL-VAD Pilot)


Sponsor

University Medical Centre Ljubljana

Enrollment

10 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD. In the clinical trial, the investigators aim to enroll 10 patients with NICM, scheduled for LVAD implantation. After successful LVAD implantation, patients will be enrolled and followed for 2 months to allow for postoperative rehabilitation and heart failure medical therapy and LVAD support optimization. All patients will then undergo autologous CD34+ cell therapy which will be intracoronaryly delivered to the target myocardium using NOGA electromechanical mapping system. All patients will be followed for 6 months after cell therapy. At baseline, and at 1, 3, and 6 months after cell therapy, the investigators will perform comprehensive clinical evaluation.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether cell therapy — using a patient's own stem cells — alongside implantation of a mechanical heart pump (Left Ventricular Assist Device, or LVAD) can help the heart muscle recover and potentially avoid the need for a heart transplant in people with non-ischemic dilated cardiomyopathy (a weakened heart not caused by blocked arteries). **You may be eligible if...** - You are 18–65 years old - You have been diagnosed with non-ischemic dilated cardiomyopathy (a weakened heart not caused by blocked arteries) - Your doctor has accepted you for an LVAD (mechanical heart support device) - You have been on optimal heart failure therapy for at least 2 months - You are able to give informed consent **You may NOT be eligible if...** - Your heart failure is caused by coronary artery disease (ischemic) - Your heart failure has a reversible untreated cause (such as thyroid disease or alcohol abuse) - You have a neuromuscular condition such as Duchenne muscular dystrophy - You have a recent or active infection, acute organ failure, severe anemia, or significant blood, liver, or kidney problems - You have a history of blood clots or bleeding disorders - You are significantly obese (BMI above 35) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD34+ stem cell therapy

After 5-days GCSF stimulation all patients will undergo apheresis to obtain CD34+ cell which will subsequently be injected in the target coronary artery using microcatheter.


Locations(1)

University Medical Center Ljubljana

Ljubljana, Slovenia

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NCT06154044


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