Cell Therapy in HFpEF

Heart Failure With Normal Ejection Fraction Clinical Trial

— CELLpEF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923609
• Other study ID #: CELLpEF
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: March 2022

Study information

• Verified date: May 2023
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Normal Ejection Fraction

Intervention

Biological:
• Cell Therapy
Electro-anatomical mapping will be performed using the Biosense NOGA system (Biosense-Webster, Diamond Bar, California). Local diastolic function will be assessed by a novel algorhithm that allows for the measuring local ventricular relaxation times at each of the sampling points. Target areas for cell delivery will be defined as the myocardial segments with the evidence of local diastolic dysfunction and myocardial hibernation. Transendocardial delivery of cell suspension in the SC Group will be performed with MyoStar® (Biosense Webster) injection catheter. Each patient will receive 20 injections of 0.3 mL of stem cell suspension.

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular filling pressures (E/e') assessed by echocardiography	The E/e' ratio will be calculated from early transmitral velocity divided by peak left ventricular relaxation velocity for estimation of the left ventricular filling pressure.	Baseline, 6 months and 1 year
Secondary	Change in exercise capacity	6-minute walk test will be performed by a blinded observer according to the standard protocol.	Baseline, 6 months and 1 year
Secondary	Change in NT-proBNP levels	NT-proBNP assays will be performed at a central independent laboratory, blinded to the patient's clinical data using a commercially available kit (Roche Diagnostics, Mannheim, Germany).	Baseline, 6 months and 1 year
Secondary	Change in systolic strain	Left ventricular longitudinal strains will be analyzed by speckle tracking echocardiography from apical four-chamber, two-chamber, and long-axis views.	Baseline, 6 months and 1 year
Secondary	Change in diastolic dysfunction grade	Diastolic dysfunction will be graded according based on E/A ratio and left atrial pressure estimation.	Baseline, 6 months and 1 year