Clinical Trial

Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure

Study acronym: BioVAT-HF
Recruiting Phase 1/2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-05-15; most recent amendment 2026-02-19.
Status change: Not Yet Recruiting → Recruiting 2021-02-18
Trial Details
NCT Number NCT04396899
Lead Sponsor University Medical Center Goettingen
Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), University Medical Center Freiburg, Repairon GmbH
Conditions Heart Failure
Enrollment 53 participants
Start Date 2020-02-03
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-20