Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy

PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Dilated Cardiomyopathy
Interventions
BIOLOGICAL

CD34+ autologous stem cell transplantation

Peripheral blood stem cells will be mobilized by daily subcutaneous injections of filgrastim; CD34+ cells will be collected via apheresis and labeled with technetium. Patients will undergo myocardial perfusion scintigraphy for myocardial viability assessment and the collected CD34+ cells will be injected intracoronary in the artery supplying the segments of reduced tracer accumulation

DRUG

Bone Marrow Stimulation

Patients will undergo filgrastim stimulation and viability assessment using the same protocol as in Arm 1. However, in this group, no intracoronary stem cell delivery will be performed; the patients will receive placebo (saline).

BIOLOGICAL

SC therapy

In the SC group, CD34+ cells were mobilized by granulocyte colony-stimulating factor and collected via apheresis. Patients underwent myocardial scintigraphy and cells were injected in the artery supplying segments with the greatest perfusion defect

Trial Locations (1)

1000

Ljubljana University Medical Center, Ljubljana

All Listed Sponsors
collaborator

Blood Transfusion Centre of Slovenia

OTHER_GOV

collaborator

Stanford University

OTHER

lead

University Medical Centre Ljubljana

OTHER

NCT00629018 - Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy | Biotech Hunter | Biotech Hunter