NCT06154044RecruitingPhase 2
Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support
The Effects of Cell Therapy on Myocardial Recovery in Chronic Heart Failure Patients Undergoing Left Ventricular Assist Device Support: A Pilot Trial (CELL-VAD Pilot)
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 6 Nov 2023
- Start date
- 1 May 2022
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Heart failure
- NCT number
- NCT06154044
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- From 1 May 2022 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.