A globally unique clinical trial is investigating whether artificial heart tissue from induced pluripotent stem cells can permanently strengthen the heart muscle of patients with heart failure by rebuilding heart muscle tissue.
The study, called BioVAT-HF-DZHK20, is being conducted at the University Medical Center Göttingen and the University Medical Center Schleswig-Holstein and funded by the German Center for Cardiovascular Research and Repairon GmbH. In phase 1 of the study, the dose finding phase, so-called heart patches consisting of 200, 400 or 800 million heart cells were implanted in 10 patients in order to determine the maximum safe dose. The study is now to be continued and its effectiveness investigated. An initial interim evaluation is expected after 15 patients have been treated. A total of 35 patients are to be treated. After many years of preclinical development and research, the transplantation of artificial heart tissue offers a novel therapeutic option for patients with severe heart failure.
Heart failure affects around 60 million people worldwide. Despite advances in pharmacological and interventional heart failure therapies, 20% of patients with heart failure die within a year. After five years, 50% of patients with heart failure have died despite optimal medical therapy. Due to the dramatic demographic changes in our ageing population, the prevalence of heart failure will continue to increase, leading to the death of more people than any other disease. Therefore, novel treatment options are important.
