Ignite Creation Date:
2024-05-06 @ 9:12 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02923609
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2016-10-03
Brief Title:
Cell Therapy in HFpEF
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
A PILOT TRIAL OF CELL THERAPY IN HEART FAILURE WITH PRESERVED EJECTION FRACTION
Status:
COMPLETED
Status Verified Date:
2023-05
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:
CELLpEF
Brief Summary:
The primary objective of the study is to investigate safety and efficacy of transendocardial CD34 cell therapy in patients with HFpEF by evaluating changes in myocardial structure and function patient exercise capacity and clinical outcome
The safety end-points include serious adverse events SAEs defined as any serious event that may result in persistent or significant disability or incapacity and included death heart transplantation sustained ventricular arrhythmia ventricular tachycardia or ventricular fibrillation and heart failure exacerbation requiring hospitalization
The safety end-points include serious adverse events SAEs defined as any serious event that may result in persistent or significant disability or incapacity and included death heart transplantation sustained ventricular arrhythmia ventricular tachycardia or ventricular fibrillation and heart failure exacerbation requiring hospitalization
Detailed Description:
In all patients peripheral blood stem cells will be mobilized by daily subcutaneous injections of G-CSF 10 mcgkg divided bid for 5 days Peripheral blood stem cells will then be collected with Miltenyi cell separator Miltenyi Biotech Germany and the magnetic cell separator Isolex 300i Nexell Therapeutics Inc California USA will be used for the immunomagnetic positive selection of the CD34 cells
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None