Tests a patient's own stem cells in heart failure patients with a heart pump
Tests the patient's own stem cells delivered to the heart in people with heart failure.
Plain-language title generated from the registry record
Registry title: Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support
Key facts
- Where
- Ljubljana, SloveniaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06154044, who can take part
Where in Slovenia
- University Medical Center LjubljanaLjubljana, SloveniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Centre Ljubljana
- Trial code
- NCT06154044
- Record updated
- 26 January 2026
- Original description
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.Read full original descriptionShow less
The Effects of Cell Therapy on Myocardial Recovery in Chronic Heart Failure Patients Undergoing Left Ventricular Assist Device Support: A Pilot Trial (CELL-VAD Pilot)
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.
Patient inclusion criteria will consist of all of the following:; non-ischemic dilated cardiomyopathy; patient accepted for LVAD support; optimal (or maximal tolerable therapy) heart failure ≥ 2 months; age 18-65 years; ability to provide informed consent; Patient exclusion criteria will consist of any of the following:; 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; acute multi-organ failure; clinically significant anemia (Hb < 10 g/dL); clinically significant leukopenia (L < 2 x 109/L) or leukocytosis (L > 14 x 109/L); clinically significant thrombocytopenia (TRC < 50 x 109/L); known disorders of hemostasis that can not be corrected; history of any thromboembolic complications; chronic kidney disease (higher than stage III); chronic liver disease (Child B or C); diminished functional capacity for other reasons such as COPD, moderate or severe claudications, severe musculosceletal system pain or morbid obesity (BMI > 35 kg/m2); aortic stenosis (AVA < 1.3 cm2) or ocluded aortic valve; artificial (mechanical or biological) aortic valve; patients with reduced immune response; history of limphoprolipherative disorders or malignancy within 5 years; left ventricular thrombus; participation in another interventional clinical trial; life expectancy less than 12 months; known hypersensitivity to DMSO, penicillin or streptomycin.