Principal investigator: prof. Bojan Vrtovec, MD, PhD

Contact: e-mail: tx.srca@kclj.si, phone: +386-1-522-1163 (weekdays from 8:00 am to 2:00 pm)

Background

Stem cell therapy appears to represent a safe and effective treatment for patients with heart failure due to dilated cardiomyopathy.

Study Aims

The aim of this study is to investigate whether repetitive stem cell application would be associated with superior clinical benefits when compared to single stem cell application in patients with dilated cardiomyopathy.

Methods

The REMEDIUM trial will consist of a prospective randomized study design. We plan to enroll 80 patients with dilated cardiomyopathy. All patients will undergo stem cell mobilization; thereafter CD34+ cells will be collected via apheresis. Patients will be randomly allocated in 1:1 ratio in repetitive cell administration (Group A) and single administration (Group B).

Group A will receive cell therapy at baseline, and again after 6 months; Group B will only receive one dose of cells at baseline. Before cell administration we will perform detailed electroanatomical mapping of the left ventricle, which will enable us to perform regional and global multimodality assessment of viability, contractility, and electrophysiological properties of the myocardium.

The total duration of the follow up will be 1 year. At the time of enrollment, and at 6-month intervals thereafter, we will perform detailed clinical evaluation, echocardiography, high-resolution electrocardiography, 6-minute walk test, and measure plasma levels of NT-proBNP. Magnetic resonance imaging (MRI) will be performed in all eligible patients at baseline, 6 months, and 1 year.

Expected results

When compared to single cell administration we expect repetitive cell therapy to be associated with superior effects on myocardial structure and function, laboratory parameters, electro-anatomical parameters, patient exercise capacity and outcome.