Stem-cell ‘heart patch’ shows promise for heart failure treatment

by Lena Bösch, Universitätsmedizin Göttingen – Georg-August-Universität

Study results open door to heart failure treatment with 'heart patch'The heart patch is produced from induced pluripotent stem cells derived from heart muscle cells in a collagen hydrogel. Credit: UMG/Eva Meyer-Besting

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 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.Play

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Contracting Rhesus EHM suspended in Ringer solution. Spontaneous contractions of EHM can be readily observed. Credit: Nature (2025). DOI: 10.1038/s41586-024-08463-0

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.

Treating heart failure with stem-cell engineered 'heart patch'Remuscularization of the human heart. Credit: Nature (2025). DOI: 10.1038/s41586-024-08463-0

“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.

More information: Wolfram-Hubertus Zimmermann, Engineered heart muscle allografts for heart repair in primates and humans, Nature (2025). DOI: 10.1038/s41586-024-08463-0. www.nature.com/articles/s41586-024-08463-0

Journal information:Nature

Provided by Universitätsmedizin Göttingen – Georg-August-Universität


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