Ignite Creation Date:
2024-05-06 @ 2:40 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04396899
Status:
RECRUITING
Last Update Posted:
2023-03-27
First Post:
2020-05-11
Brief Title:
Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
Sponsor:
University Medical Center Goettingen
Organization:
University Medical Center Goettingen
Study Overview
Official Title:
Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure
Status:
RECRUITING
Status Verified Date:
2023-03
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:
BioVAT-HF
Brief Summary:
The BioVAT-HF trial will test the hypothesis that cardiomyocyte implantation via engineered heart muscle EHM the proposed investigational medicinal product IMP designated Biological Ventricular Assist Tissue or BioVAT results in sustainable remuscularization and biological enhancement of myocardial performance in the failing heart EHM are constructed from defined mixtures of induced pluripotent stem cell iPSC-derived cardiomyocytes and stromal cells in a bovine collagen type I hydrogel Comprehensive preclinical testing confirmed the rationale for the clinical translation of the myocardial remuscularization strategy by EHM implantation The patient target population for EHM therapy is patients suffering from advanced heart failure with reduced ejection fraction HFrEF EF 35 and no realistic option for heart transplantation
Detailed Description:
None
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