Actively Recruiting
Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support
Led by University Medical Centre Ljubljana · Updated on 2026-01-26
10
Participants Needed
1
Research Sites
356 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-ischemic dilated cardiomyopathy
- Patient accepted for LVAD support
- On optimal or maximum tolerable heart failure therapy for at least 2 months
- Age between 18 and 65 years
- Ability to provide informed consent
You will not qualify if you...
- Ischemic cardiomyopathy
- Cardiomyopathy with untreated reversible causes such as thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity, or chronic uncontrolled tachycardia
- Cardiomyopathy related to neuromuscular disorders like Duchenne's muscular dystrophy
- Ongoing or recent infection within the last month
- Acute multi-organ failure
- Clinically significant anemia (hemoglobin less than 10 g/dL)
- Clinically significant leukopenia (less than 2 x 10^9/L) or leukocytosis (greater than 14 x 10^9/L)
- Clinically significant thrombocytopenia (platelets less than 50 x 10^9/L)
- Known uncorrectable bleeding disorders
- History of thromboembolic complications
- Chronic kidney disease stage higher than III
- Chronic liver disease classified as Child B or C
- Reduced functional capacity due to COPD, moderate or severe claudication, severe musculoskeletal pain, or morbid obesity (BMI over 35 kg/m2)
- Aortic stenosis (aortic valve area less than 1.3 cm2) or occluded aortic valve
- Presence of artificial (mechanical or biological) aortic valve
- Reduced immune response
- History of lymphoproliferative disorders or malignancy within 5 years
- Left ventricular thrombus
- Participation in another interventional clinical trial
- Life expectancy less than 12 months
- Known allergy to DMSO, penicillin, or streptomycin
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
M
Mateja Lani
CONTACT
G
Gregor Poglajen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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