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

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

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

Conditions3

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