Clinical Trial

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

Study acronym: CELL-VAD
Recruiting Phase 2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-11-22.
Trial Details
NCT Number NCT06154044
Lead Sponsor University Medical Centre Ljubljana
Conditions Heart Failure, Mechanical Circulatory Support
Enrollment 10 participants
Start Date 2022-05-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-26