Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Medical Centre Ljubljana
About this trial
The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD. In the clinical trial, the investigators aim to enroll 10 patients with NICM, scheduled for LVAD implantation. After successful LVAD implantation, patients will be enrolled and followed for 2 months to allow for postoperative rehabilitation and heart failure medical therapy and LVAD support optimization. All patients will then undergo autologous CD34+ cell therapy which will be intracoronaryly delivered to the target myocardium using NOGA electromechanical mapping system. All patients will be followed for 6 months after cell therapy. At baseline, and at 1, 3, and 6 months after cell therapy, the investigators will perform comprehensive clinical evaluation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
non-ischemic dilated cardiomyopathy
patient accepted for LVAD support
optimal (or maximal tolerable therapy) heart failure ≥ 2 months
age 18-65 years
Disqualifiers
ischemic cardiomyopathy
Cardiomyopathy with a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity & chronic uncontrolled tachycardia.
Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy.
ongoing or recent (less than 1 month) infection
Trial design
Design model
Single group
Treatments tested in this trial
CD34+ stem cell therapy
Biological/VaccineAfter 5-days GCSF stimulation all patients will undergo apheresis to obtain CD34+ cell which will subsequently be injected in the target coronary artery using microcatheter.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
change in left ventricular ejection fraction (LVEF)
change in left ventricular ejection fraction (LVEF), measured by transthoracic echocardiography using Simpson's rule between the time of stem cell therapy and 6 months.
Time frame
Baseline to 6 months2
Changes in left ventricular end-systolic and end-diastolic dimensions
Changes in left ventricular end-systolic (LVESd) and end-diastolic dimensions (LVEDd) measured by transthoracic echocardiography in parasternal longitudinal axis with expected change \> 10%.
Time frame
Baseline to 3 and 6 months3
Changes in left ventricular longitudinal and circumferential strains
Changes in left ventricular longitudinal and circumferential strains will be measured using transthoracic echocardiography and segmental wall motion analysis with expected change \> 10%.
Time frame
Baseline to 3 and 6 months4
Changes in right ventricular size
Changes in right ventricular size (RVIDd) will be measured using transthoracic echocardiography with expected change \> 10%.
Time frame
Baseline to 3 and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov