Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

September 30, 2017

Study Completion Date

December 31, 2017

Conditions
Dilated CardiomyopathyHeart Failure
Interventions
BIOLOGICAL

Stem cell therapy

Bone marrow cells will be mobilized into peripheral blood by daily subcutaneous injections of G-CSF (10 µg/kg daily) and collected by leukapheresis. Positive immunomagnetic selection of CD34+ cells will be performed. Electroanatomic mapping of the left ventricle will be performed using the Biosense NOGA system (Biosense-Webster®, Diamond Bar, CA). The target area for cell delivery will be defined as the myocardial segments with unipolar voltage potentials ≥8.3 mV, bipolar amplitudes \>1.9 mV, and linear shortening \<6%. Intramyocardial delivery of cell suspension will be performed with the MyoStar (BiosenseWebster®, Diamond Bar, CA) injection catheter. Each patient will receive 20 injections (0.3 mL each; total volume of 6 mL). All the procedures will be repeated 6 months after baseline.

Trial Locations (1)

1000

UMC Ljubljana, Ljubljana

All Listed Sponsors
lead

University Medical Centre Ljubljana

OTHER

NCT02248532 - Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM) | Biotech Hunter | Biotech Hunter