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)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Slovenia
University Medical Center Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
Mateja Lani
mateja.lani@kclj.si
+38615221163
Backup
Gregor Poglajen, MD, PhD
gregor.poglajen@kclj.si
+38615228671
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 10
Treatments
Experimental: Treatment Arm
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 delivered via intracoronary route. All patients will be followed for 6 months after cell therapy. At baseline, and at 1, 3 and 6 months after cell therapy, we will perform comprehensive clinical evaluation. Clinical, biochemical, biomarker-related, imaging and myocardial histology data will be transferred to a secured central database.
Related Therapeutic Areas
Sponsors
Leads: University Medical Centre Ljubljana

This content was sourced from clinicaltrials.gov