Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06154044
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-11-06
Brief Title:
Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
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
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CELL-VAD
Brief 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
Detailed Description:
PROBLEM IDENTIFICATION Left ventricular assist device LVAD technology has evolved significantly and represents a standard of care for patients with advanced chronic heart failure However a significant discrepancy exists between structural and functional recovery of the failing myocardium as only a small fraction 2 of LVAD-supported patients demonstrate reverse structural remodeling and eventually reach clinically significant and stable functional improvement that allows for LVAD removal Thus there is a significant unmet need to define better the mechanisms of myocardial reverse remodeling in advanced chronic heart failure patients undergoing LVAD support
OBJECTIVES
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 The investigators propose a Phase II non-randomized single-center clinical study focusing on 1 the administration of stem cell therapy that would allow for durable improvements in heart function and structure in NICM-LVAD patients By using integrated analysis of multimodality imaging and biomarkers of fibrosis and angiogenesis this project aims to 2 better define the pathophysiological mechanisms involved in myocardial recovery Additionally the investigators also aim to 3 define the safety parameters of stem cell therapy in NICM-LVAD patients Based on these aims the specific objectives of the CELL-VAD Pilot trial are
The primary objective of this study is to investigate the safety and efficacy of stem cell therapy in NICM-LVAD patients by evaluating changes in left ventricular structure and function biomarkers of neurohormonal activation patient exercise capacity and clinical outcome
The secondary objective of this study is to better define pathophysiological mechanisms involved in myocardial recovery in NICM-LVAD patients by evaluating temporal changes in myocardial perfusion and in biomarkers of myocardial fibrosis in angiogenesis
STUDY DESIGN The CELL-VAD Pilot trial consists of a clinical trial WP1 and a multimodality imaging platform WP2 The overall duration of the project is 3 years 36 months
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 delivered via the 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 the investigators will perform comprehensive clinical evaluation Clinical biochemical biomarker-related imaging and myocardial histology data will be transferred to a secured central database
The investigators also aim to develop a personalized multimodality imaging platform by integrating the data obtained from advanced echocardiography and PET imaging
EXPECTED OUTCOMES The investigators expect to demonstrate that in NICM-LVAD patients transendocardial autologous CD34 cell therapy is safe and efficient promoting the structural and functional reverse remodelling of the failing myocardium Additionally the results of this trial will establish a solid framework of knowledge and expertise for future clinical trials to build on
OBJECTIVES
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 The investigators propose a Phase II non-randomized single-center clinical study focusing on 1 the administration of stem cell therapy that would allow for durable improvements in heart function and structure in NICM-LVAD patients By using integrated analysis of multimodality imaging and biomarkers of fibrosis and angiogenesis this project aims to 2 better define the pathophysiological mechanisms involved in myocardial recovery Additionally the investigators also aim to 3 define the safety parameters of stem cell therapy in NICM-LVAD patients Based on these aims the specific objectives of the CELL-VAD Pilot trial are
The primary objective of this study is to investigate the safety and efficacy of stem cell therapy in NICM-LVAD patients by evaluating changes in left ventricular structure and function biomarkers of neurohormonal activation patient exercise capacity and clinical outcome
The secondary objective of this study is to better define pathophysiological mechanisms involved in myocardial recovery in NICM-LVAD patients by evaluating temporal changes in myocardial perfusion and in biomarkers of myocardial fibrosis in angiogenesis
STUDY DESIGN The CELL-VAD Pilot trial consists of a clinical trial WP1 and a multimodality imaging platform WP2 The overall duration of the project is 3 years 36 months
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 delivered via the 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 the investigators will perform comprehensive clinical evaluation Clinical biochemical biomarker-related imaging and myocardial histology data will be transferred to a secured central database
The investigators also aim to develop a personalized multimodality imaging platform by integrating the data obtained from advanced echocardiography and PET imaging
EXPECTED OUTCOMES The investigators expect to demonstrate that in NICM-LVAD patients transendocardial autologous CD34 cell therapy is safe and efficient promoting the structural and functional reverse remodelling of the failing myocardium Additionally the results of this trial will establish a solid framework of knowledge and expertise for future clinical trials to build on
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None