drugset / Trial / NCT06154044

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

NCT06154044 ↗

Phase 2 Recruiting 10 enrolled University Medical Centre Ljubljana
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-05-01
Primary completion
2028-12-31
Completion
2029-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CD34+ stem cell therapy Cell therapy — Other

Indications