Status:
UNKNOWN
Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Heart Failure
Mechanical Circulatory Support
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 clin...
Detailed Description
PROBLEM IDENTIFICATION Left ventricular assist device (LVAD) technology has evolved significantly and represents a standard of care for patients with advanced chronic heart failure. However, a signifi...
Eligibility Criteria
Inclusion
- Patient inclusion criteria will consist of all of the following:
- non-ischemic dilated cardiomyopathy
- patient accepted for LVAD support
- optimal (or maximal tolerable therapy) heart failure ≥ 2 months
- age 18-65 years
- ability to provide informed consent
- Patient exclusion criteria will consist of any of the following:
- ischemic cardiomyopathy
- 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.
- Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy.
- ongoing or recent (less than 1 month) infection
- acute multi-organ failure
- clinically significant anemia (Hb \< 10 g/dL)
- clinically significant leukopenia (L \< 2 x 109/L) or leukocytosis (L \> 14 x 109/L)
- clinically significant thrombocytopenia (TRC \< 50 x 109/L)
- known disorders of hemostasis that can not be corrected
- history of any thromboembolic complications
- chronic kidney disease (higher than stage III)
- chronic liver disease (Child B or C)
- diminished functional capacity for other reasons such as COPD, moderate or severe claudications, severe musculosceletal system pain or morbid obesity (BMI \> 35 kg/m2)
- aortic stenosis (AVA \< 1.3 cm2) or ocluded aortic valve
- artificial (mechanical or biological) aortic valve
- patients with reduced immune response
- history of limphoprolipherative disorders or malignancy within 5 years
- left ventricular thrombus
- participation in another interventional clinical trial
- life expectancy less than 12 months
- known hypersensitivity to DMSO, penicillin or streptomycin
Exclusion
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06154044
Start Date
May 1 2022
End Date
May 31 2025
Last Update
December 1 2023
Active Locations (1)
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1
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000