Heart failure affects 60 million people worldwide. With current treatment and medical care, one out of five patients with heart failure will die within 12 months – there is no cure. This means that half of those diagnosed with heart failure today will not be alive in 5 years. The BioVAT-HF-DZHK20 Phase I/II clinical trial comes after 25 years of comprehensive preclinical development, and is the first to investigate whether the implantation of a heart muscle patch, grown in a laboratory from stem cells, can safely and effectively repair the failing heart.
Approval of the BioVAT-HF-DZHK20 multicenter trial was granted by the Paul-Ehrlich-Institute at the end of 2020. The trial is scheduled to enroll 53 patients with advanced heart failure. Additional participating centers include the University Medical Center Schleswig-Holstein in Lübeck and the Heart- and Diabetes Center of the Ruhr University of Bochum in Bad Oeynhausen.
Short description of Engineered Heart Muscle (EHM)
Engineered heart muscle (EHM) is prepared from human induced pluripotent stem cell (iPSC)-derived heart muscle cells and collagen. After 6 years of optimization and valida-tion of the manufacturing process as well as comprehensive safety and efficacy testing, following advice by the Paul-Ehrlich-Institute (the responsible authority for advanced medicinal products [ATMPs] in Germany), approval of manufacturing and clinical testing of the first pluripotent stem cell-derived innovative medicinal product (IMP) in Germany was granted by the competent authorities. The concept of tissue engineered heart repair with EHM as well as the protocols to produce EHM as an IMP were developed at the Institute of Pharmacology and Toxicology at the University Medical Center Göttingen, Germany, by Prof. Dr. Wolfram-Hubertus Zimmermann and colleagues. With evidence for safe and efficacious long-term retention in preclinical models, the first patients are recruited to investigate whether the preclinical observations translate to improve care in and ideally offer a cure to patients with advanced heart failure.
Study title: Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure BioVAT-DZHK20
Scientific contact: Professor Dr. Wolfram-Hubertus Zimmermann, Institute of Pharmacology and Toxicology at the University Medical Center Göttingen, Georg-August-University, biovat.info(at)med.uni-goettingen.de
Contact: Christine Vollgraf, Press and Public Relations, German Center for Cardiovascular Research (DZHK), phone +49 30 3465 529 02, presse(at)dzhk.de
Source: Press release University Medical Center Göttingen
Translational Research Project: GMP-production of engineered human myocardium for heart failure repair