Approval of the world's first clinical trial on heart repair
‘We were able to show in an animal model that the implantation of heart patches is suitable for the permanent reconstruction of the heart muscle in heart failure. The challenge was to obtain sufficient heart muscle cells from induced pluripotent stem cells from rhesus monkeys to achieve a sustainable repair of the heart without causing dangerous side effects such as cardiac arrhythmia or tumour growth,’ explains Prof. Zimmermann. ‘The results of these investigations were decisive for the approval of the world's first clinical trial to repair the heart with tissue implants developed in the laboratory in people with advanced heart muscle weakness.’
The results of the successful preclinical trial and a first clinical case report have been published in the renowned scientific journal ‘Nature’.
‘For the first time, we were able to observe the development of real heart muscle in the human heart. The successful treatment shows that we are on the right track with the heart patch,’ says Prof Dr Ingo Kutschka, Director of the Department of Cardiothoracic and Vascular Surgery at the UMG and Surgical Director of the BioVAT-HF-DZHK20 study at the UMG.
Prof. Dr Stephan Ensminger, Director of the Clinic for Cardiac and Thoracic Vascular Surgery at the University Heart Centre Lübeck of the UKSH and Surgical Director of the BioVAT-HF-DZHK20 study at the UKSH, adds: ‘The heart patch is an outstanding example of translational research - from the laboratory to clinical application. It has the potential to replace mechanical support systems in certain cases and offer patients a permanent solution.’
Translational research: from the laboratory to clinical application
‘This work summarises our most important findings on the way to clinical trials and can therefore serve as a model for the transfer of novel stem cell-based therapies to the clinic. In addition, our work proves for the first time that heart muscle repair through heart muscle reconstruction is also possible in humans. I would like to thank the entire team for the successful collaboration over the many years,’ says Prof Zimmermann.
The preclinical testing of the heart patch treatment was completed in collaboration with the DPZ and Stanford University. Based on the results, the BioVAT-HF-DZHK20 clinical trial was initiated at the UMG and the UKSH in cooperation with the German Centre for Cardiovascular Research (DZHK) and Göttingen-based Repairon GmbH.
Background of heart patches
The heart patch technology was developed by Zimmermann and his colleagues over a period of more than 30 years from the first model in the culture dish to clinical application. The preparation of the BioVAT-HF-DZHK20 clinical trial took place between 2014 and 2021 in close coordination with the responsible higher federal authority, the Paul Ehrlich Institute. Since 2021, patients with advanced myocardial insufficiency have been treated at the UMG and the UKSH, Lübeck campus. These patients developed life-threatening illnesses even though they had previously been treated according to modern medical care guidelines. The German Centre for Cardiovascular Research (DZHK), together with Repairon GmbH, a spin-off from the UMG, supported both the preclinical and clinical trials. Following simulation in rhesus monkeys under near-clinical conditions at the DPZ, a total of 15 patients have already been treated with ten billion heart muscle cells from induced pluripotent stem cells in the form of engineered heart muscle (EHM). After dose optimisation has already been completed, the first clinical data on the use of heart patches made from 800 million heart muscle cells in patients with severe myocardial insufficiency is expected by the end of 2025.
Original publication:
Engineered heart muscle allografts for heart repair in primates and humans. Jebran, AF., Seidler, T., Tiburcy, M. et al., Nature (2025). https://doi.org/10.1038/s41586-024-08463-0
Scientific Contact:
Prof. Dr. Wolfram-Hubertus Zimmermann, University Medical Centre Göttingen, Georg-August-University, Institute of Pharmacology and Toxicology
biovat.info@med.uni-goettingen.de, www.biovat.dzhk.de
Source: Press release University Medical Centre Göttingen
