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Cell Therapy in HFpEF — CELLpEF  

Heart Failure With Normal Ejection Fraction Clinical Trial

Official title:
A PILOT TRIAL OF CELL THERAPY IN HEART FAILURE WITH PRESERVED EJECTION FRACTION

Clinical Trial Summary

The primary objective of the study is to investigate safety and efficacy of transendocardial CD34+ cell therapy in patients with HFpEF by evaluating changes in myocardial structure and function, patient exercise capacity and clinical outcome. The safety end-points include serious adverse events (SAEs), defined as any serious event that may result in persistent or significant disability or incapacity and included death, heart transplantation, sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation), and heart failure exacerbation requiring hospitalization.

Clinical Trial Description

In all patients, peripheral blood stem cells will be mobilized by daily subcutaneous injections of G-CSF (10 mcg/kg, divided b.i.d) for 5 days. Peripheral blood stem cells will then be collected with Miltenyi cell separator (Miltenyi Biotech, Germany) and the magnetic cell separator Isolex 300i (Nexell Therapeutics Inc., California, USA) will be used for the immunomagnetic positive selection of the CD34+ cells. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02923609
Study type Interventional
Source University Medical Centre Ljubljana
Contact
Status Completed
Phase Phase 2
Start date January 2016
Completion date March 2022
View Details
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