Heart patch study advances potential treatment for advanced heart failure

The BioVAT-HF-DZHK20 clinical trial is currently evaluating a regenerative therapy for individuals with advanced heart failure. This novel approach involves implanting a tissue-engineered heart patch, known as engineered heart muscle (EHM), to restore heart function. The EHM patch consists of heart cells derived from induced pluripotent stem cells embedded in a collagen hydrogel. 

“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,” says Professor Wolfram-Hubertus Zimmermann, director of the Department of Pharmacology and Toxicology at UMG and Scientific Director of the heart patch study. 

• The heart patches contain up to 200 million cells and significantly improve heart function through re-muscularization (building of new heart muscle). 

• Imaging and tissue analysis confirmed that implanted heart muscle cells are retained under immune suppression. 

• The preclinical studies provided essential data for regulatory approval of the first-in-human clinical trial. 

The BioVAT-HF-DZHK20 clinical trial has already begun treating patients with severe heart failure at UMG and UKSH. A total of 15 patients have received heart patches containing billions of cardiac muscle cells, with dose optimization ongoing. Interim data from these treatments is expected by the end of 2025. 

Professor Ingo Kutschka, director of the Department of Cardiothoracic and Vascular Surgery at UMG and surgical director of the BioVAT-HF-DZHK20 study, emphasized, “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.” 

Prof. Stephan Ensminger, director of the Clinic for Cardiac and Thoracic Vascular Surgery at the University Heart Center Lübeck of UKSH, highlighted the significance of translational research: “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.” 

The heart patch technology has been under development for over three decades. The late preclinical phase of the BioVAT-HF-DZHK20 clinical trial (2014-2021) was conducted in consultation with the Paul Ehrlich Institute, Germany's regulatory body for biomedical research. Since 2021, patients with advanced heart failure, who no longer respond to standard treatments, have received engineered heart muscle implants as part of this study. 

MEDICA-tradefair.com; Source: University Medical Center Göttingen