NCT06154044 Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support
| NCT ID | NCT06154044 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Medical Centre Ljubljana |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 10 participants in total. It began in 2022-05-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Patient inclusion criteria will consist of all of the following: 1. non-ischemic dilated cardiomyopathy 2. patient accepted for LVAD support 3. optimal (or maximal tolerable therapy) heart failure ≥ 2 months 4. age 18-65 years 5. ability to provide informed consent Patient exclusion criteria will consist of any of the following: 1. ischemic cardiomyopathy 2. 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. 3. Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy. 4. ongoing or recent (less than 1 month) infection 5. acute multi-organ failure 6. clinically significant anemia (Hb \< 10 g/dL) 7. clinically significant leukopenia (L \< 2 x 109/L) or leukocytosis (L \> 14 x 109/L) 8. clinically significant thrombocytopenia (TRC \< 50 x 109/L) 9. known disorders of hemostasis that can not be corrected 10. history of any thromboembolic complications 11. chronic kidney disease (higher than stage III) 12. chronic liver disease (Child B or C) 13. diminished functional capacity for other reasons such as COPD, moderate or severe claudications, severe musculosceletal system pain or morbid obesity (BMI \> 35 kg/m2) 14. aortic stenosis (AVA \< 1.3 cm2) or ocluded aortic valve 15. artificial (mechanical or biological) aortic valve 16. patients with reduced immune response 17. history of limphoprolipherative disorders or malignancy within 5 years 18. left ventricular thrombus 19. participation in another interventional clinical trial 20. life expectancy less than 12 months 21. known hypersensitivity to DMSO, penicillin or streptomycin
Contact & Investigator
Bojan Vrtovec, MD, PhD
PRINCIPAL INVESTIGATOR
UMC Ljubljana
Frequently Asked Questions
Who can join the NCT06154044 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06154044 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06154044 currently recruiting?
Yes, NCT06154044 is actively recruiting participants. Contact the research team at mateja.lani@kclj.si for enrollment information.
Where is the NCT06154044 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT06154044 clinical trial?
NCT06154044 is sponsored by University Medical Centre Ljubljana. The principal investigator is Bojan Vrtovec, MD, PhD at UMC Ljubljana. The trial plans to enroll 10 participants.
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