Personalized stem cell therapy for heart failure patients with LVAD support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.