Cell Therapy in HFpEF (CELLpEF)

University Medical Centre Ljubljana

Status and phase: Completed; Phase 2

Conditions: Heart Failure With Normal Ejection Fraction

Treatments: Biological: Cell Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02923609

CELLpEF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preserved left ventricular systolic function on echocardiography (LVEF>50%)
• Evidence of diastolic dysfunction by echocardiography (E/e'>15)
• Symptoms of heart failure
• NT-proBNP levels >300 pg/ml
• absence of permanent atrial fibrillation

Exclusion criteria

• acute multi-organ failure
• history of any malignant disease within 5 years
• diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity)
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 1 patient group

SC Group

Experimental group

Description:

In Phase 1 of the study, all patients will be treated with optimization of medical therapy for 6 months. Thereafter, all patients will cros over to Phase 2 of the study, where they will receive transendocardial CD34+ cell therapy. Follow-up of Phase 2 will last for 6 months. At the time of enrollment (6 months before cell therapy), at time of cell therapy, and 6 months thereafter we will perform detailed clinical evaluation, laboratory assays, echocardiography, 6-minute walk test, and measure plasma levels of N-terminal pro B-type natriuretic peptide (NT-proBNP).

Treatment:

Biological: Cell Therapy