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Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support

RecruitingPhase 2Ages 18 Years - 65 YearsAllUniversity Medical Centre Ljubljana
NCT06154044 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • CD34+ stem cell therapy
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Where

1 site
University Medical Center Ljubljana
Ljubljana, Slovenia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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