Personalized stem cell therapy for heart failure patients with LVAD support
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)
PHASE2 · University Medical Centre Ljubljana · NCT06154044
This study is testing a personalized stem cell treatment for heart failure patients who are getting a heart pump to see if it helps their heart recover better after surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana (other) |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT06154044 on ClinicalTrials.gov |
What this trial studies
The CELL-VAD Pilot trial aims to explore a personalized approach to stem cell therapy for patients suffering from advanced non-ischemic chronic heart failure who are receiving left ventricular assist device (LVAD) support. This Phase II clinical trial will enroll 10 patients scheduled for LVAD implantation, who will then receive autologous CD34+ cell therapy delivered to the heart after a period of postoperative rehabilitation. The study will monitor patients for 6 months post-therapy, assessing heart function and structure through comprehensive clinical evaluations and multimodality imaging. The goal is to better understand the mechanisms of myocardial recovery and the safety of stem cell therapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with non-ischemic dilated cardiomyopathy who are accepted for LVAD support and have been on optimal heart failure therapy for at least 2 months.
Not a fit: Patients with ischemic cardiomyopathy or those with reversible causes of cardiomyopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could lead to significant improvements in heart function and potentially allow some patients to have their LVAD removed.
How similar studies have performed: While the approach of using stem cell therapy in heart failure patients is being explored, this specific application in LVAD-supported patients is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ljubljana
- University Medical Center Ljubljana — Ljubljana, Slovenia (RECRUITING)
Study contacts
- Principal investigator: Bojan Vrtovec, MD, PhD — UMC Ljubljana
- Study coordinator: Mateja Lani
- Email: mateja.lani@kclj.si
- Phone: +38615221163
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Mechanical Circulatory Support, heart failure, mechanical circulatory support, stem cells