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Results from rhesus macaques provide solid ground for a first-in-human investigation of heart repair with stem cell-derived engineered heart muscle. The study is a milestone for the clinical application of the 'heart patch' as an innovative treatment option for patients with advanced heart failure at the University Medical Center Göttingen (UMG) and University Medical Center Schleswig-Hostein, Canpus Lübeck (UKSH). The study is part of the translational research strategy of the German Center for Cardiovascular Research (DZHK). The results have been published in the prestigious journal 'Nature'.
The BioVAT-HF-DZHK20 clinical trial is currently investigating a unique approach to address the unmet medical need in patients with advanced heart failure. Implantation of a tissue engineered heart patch, called engineered heart muscle (EHM), is developed to repair the failing heart. The EHM patch is a lab-grown heart muscle made up of induced pluripotent stem cell-derived heart cells embedded in a collagen hydrogel. The foundation for the translation into clinical testing was established by simulation of the clinical treatment in rhesus macaques. The EHM patch is currently the only technology that allows safe and efficacious delivery with long-term retention of cardiomyocytes in the heart.
An interdisciplinary team led by Professor Wolfram-Hubertus Zimmermann, director of the Department of Pharmacology and Toxicology at the University Medical Center (UMG) and Scientific Director of the preclinical and clinical heart patch studies, together with colleagues from the UMG and UKSH, has successfully implanted the so-called "heart patch" in patients with heart failure for the first time. The approval of this clinical trial by the responsible regulatory authority, the Paul-Ehrlich-Institute, was preceded by the documentation of safety and efficacy of the heart patch in rhesus macaques. The simulation of the clinical application in rhesus macaques at the German Primate Center - Leibniz Institute for Primate Research (DPZ) was essential to gather compelling data to support clinical translation. The researchers were able to show that implanted heart patches, consisting of up to 200 million cells, led to an improvement in heart function through re-muscularization (building of new heart muscle). Imaging techniques and tissue analysis confirmed that the implanted heart muscle cells are retained under concomitant immune suppression and strengthened the heart's pumping function.
“We have shown in rhesus macaques that cardiac patch implantation can be applied to re-muscularized the failing heart. The challenge was to generate and implant enough heart muscle cells from rhesus macaque induced pluripotent stem cells to achieve sustainable heart repair without dangerous side effects such as cardiac arrhythmia or tumor growth,” explains Professor Zimmermann. The results of the now reported investigations were crucial for the approval of the world's first clinical trial to repair the heart with tissue engineered heart muscle implants developed in the laboratory in people with advanced heart failure.
The results of the pivotal preclinical investigations and a first clinical case report have been published in the prestigious journal 'Nature'.
Original publication:
Jebran AF, Seidler T, Tiburcy M, Daskalaki M, Kutschka I, Fujita B, Ensminger S, Bremmer F, Moussavi A, Yang H, Qin X, Mißbach S, Drummer C, Baraki H, Boretius S, Hasenauer C, Nette T, Kowallick J, Ritter CO, Lotz J, Didié M, Mietsch M, Meyer T, Kensah G, Krüger D, Sakib MS, Kaurani L, Fischer A, Dressel R, Rodriguez-Polo I, Stauske M, Diecke S, Maetz-Rensing K, Gruber-Dujardin E, Bleyer M, Petersen B, Roos C, Zhang L, Walter L, Kaulfuß S, Yigit G, Wollnik B, Levent E, Roshani B, Stahl-Henning C, Ströbel P, Legler T, Riggert J, Hellenkamp K, Voigt JU, Hasenfuß G, Hinkel R, Wu JC, Behr R & Zimmermann WH. Engineered heart muscle allografts for heart repair in primates and humans. Nature (2025). DOI: 10.1038/s41586-024-08463-0
“For the first time, we have been able to observe the development of new heart muscle in the failing human heart. The successful treatment shows that we are on the right track with the heart patch,” said Professor Ingo Kutschka, director of the Department of Cardiothoracic and Vascular Surgery at UMG and surgical director of the BioVAT-HF-DZHK20 study at UMG.
Professor Stephan Ensminger, director of the Clinic for Cardiac and Thoracic Vascular Surgery at the University Heart Center Lübeck of the UKSH and Surgical Director of the BioVAT-HF-DZHK20 study at the UKSH, adds: "The heart patch is an excellent example of translational research - from the laboratory to the clinic. It has the potential to replace mechanical support systems in certain cases and provide a permanent solution for patients.”
“This paper summarizes our most important findings on the way to clinical trials and can therefore serve as a blueprint for the transfer of novel stem cell-based therapies to the clinic. In addition, our work demonstrates for the first time that myocardial repair through re-muscularization is possible in humans. Bench to bed translation was a true tour-de-force made possible by collaborative, interdisciplinary efforts over many years," said Professor Zimmermann.
Preclinical testing of the heart patch treatment has been completed in collaboration with the DPZ and Stanford University. Based on these results, the BioVAT-HF-DZHK20 clinical trial was initiated at the UMG and UKSH in cooperation with the German Centre for Cardiovascular Research (DZHK) and Repairon GmbH in Göttingen.
Background Heart Patch
The heart patch technology was developed by Zimmermann and colleagues over a period of more than 30 years, from its inception to clinical application. The late preclinical preparation of the BioVAT-HF-DZHK20 clinical trial (2014-2021) was informed by scientific advice obtained from the responsible regulatory authority, the Paul Ehrlich Institute. Since 2021, patients with advanced heart failure despite optimal medical therapy are treated at the UMG and the UKSH, Campus Lübeck. The German Center for Cardiovascular Research (DZHK) and Repairon GmbH, a spin-off of the UMG, supported both the preclinical and clinical studies. Following simulations in rhesus macaques under ‘clinical conditions’ at the DPZ, a total of 15 patients have already been treated with ten billion cardiac muscle cells from induced pluripotent stem cells delivery as engineered heart muscle (EHM). Following dose optimization, the interim data on the clinical use of heart patches made from 800 million heart muscle cells in patients with severe heart failure are expected by the end of 2025.
University Medical Center Göttingen, Georg-August-University
Department of Pharmacology and Toxicology
Professor Wolfram-Hubertus Zimmermann
Robert-Koch-Str. 40, 37075 Göttingen
Phone +49 551 / 39-65781
biovat.info@med.uni-goettingen.de
https://biovat.dzhk.de/
Jebran AF, Seidler T, Tiburcy M, Daskalaki M, Kutschka I, Fujita B, Ensminger S, Bremmer F, Moussavi A, Yang H, Qin X, Mißbach S, Drummer C, Baraki H, Boretius S, Hasenauer C, Nette T, Kowallick J, Ritter CO, Lotz J, Didié M, Mietsch M, Meyer T, Kensah G, Krüger D, Sakib MS, Kaurani L, Fischer A, Dressel R, Rodriguez-Polo I, Stauske M, Diecke S, Maetz-Rensing K, Gruber-Dujardin E, Bleyer M, Petersen B, Roos C, Zhang L, Walter L, Kaulfuß S, Yigit G, Wollnik B, Levent E, Roshani B, Stahl-Henning C, Ströbel P, Legler T, Riggert J, Hellenkamp K, Voigt JU, Hasenfuß G, Hinkel R, Wu JC, Behr R & Zimmermann WH. Engineered heart muscle allografts for heart repair in primates and humans. Nature (2025). DOI: 10.1038/s41586-024-08463-0
https://pharmacology.umg.eu/ - Video
The heart patch is produced from induced pluripotent stem cells derived heart muscle cells in a coll ...
umg/eva meyer-besting
Professor Wolfram-Hubertus Zimmermann, director of the Department of Pharmacology and Toxicology at ...
umg/frank stefan kimmel
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