Condition: Heart Failure · Sponsor: University Medical Center Goettingen
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.
This description comes directly from the study's public registry record.
Wolfram-Hubertus Zimmermann, Prof. · +49 551 / 3965781 · sekretariat.pharma@med.uni-goettingen.de
Florian Walker, Dr. · +49 551 / 3960825 · biovat@med.uni-goettingen.de
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| University Medical Center Göttingen | Göttingen, Lower Saxony, Germany | Recruiting |
| Herz- und Diabeteszentrum Nordrhein-Westfalen | Bad Oeynhausen, North Rhine-Westphalia, Germany | Not Yet Recruiting |
| University Medical Center Schleswig-Holstein | Lübeck, Schleswig-Holstein, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04396899