‘Heart patch’ from stem cells may cure heart failure

The results obtained in a study on rhesus macaques provide a solid basis for the first study of heart repair in humans using stem cell-engineered heart muscle. The study, conducted at the University of Göttingen Medical Center (UMG) and the University of Schleswig-Hostein Medical Center, Kanpus-Lübeck (UKSH), is a milestone for the clinical application of the “heart patch” as an innovative treatment for patients with advanced heart failure. The results of the study are published in the journal Nature.

The BioVAT-HF-DZHK20 clinical trial is exploring a unique approach to address the unmet medical need of patients with advanced heart failure. Implantation of a tissue-engineered heart patch, called engineered heart muscle (EHM), is designed to repair a weakened heart.

The EHM patch is a lab-grown heart muscle composed of induced pluripotent stem cells embedded in a collagen hydrogel. The foundation to move into clinical trials was laid by modeling clinical treatments on rhesus macaques. The EHM patch is currently the only technology that provides safe and effective delivery and long-term maintenance of cardiomyocytes in the heart.

An interdisciplinary team led by Prof. Wolfram-Hubertus Zimmermann, Director of the Department of Pharmacology and Toxicology at the University Medical Center (UMG) and scientific leader of the preclinical and clinical studies of the heart patch, together with colleagues from UMG and UKSH, successfully implanted the so-called “ patch” in patients with heart failure for the first time.

The approval of this clinical trial by the responsible regulatory body, the Paul Ehrlich Institute, was preceded by documentation of the safety and efficacy of the cardiac patch in rhesus macaques. Modeling of the clinical application on rhesus macaques at the German Primate Center, Leibniz Institute for Primate Research, was necessary to gather convincing data to support the application in humans.

The researchers were able to show that the implanted heart patches, consisting of 200 million cells, led to improved heart function through remuscularization (building new heart muscle). Imaging techniques and tissue analysis confirmed that the implanted heart muscle cells persisted while suppressing immunity and enhancing the pumping function of the heart.

“We have shown in rhesus macaques that cardiac patch implantation can be applied to remuscularize a failing heart. The challenge was to generate and implant enough heart muscle cells from induced pluripotent stem cells from rhesus macaques to achieve sustainable heart repair without dangerous side effects such as cardiac arrhythmias or tumor growth,” explains Professor Zimmermann.

The research results now reported were a decisive factor for the approval of the world’s first clinical trial for heart repair using the tissue-engineered heart muscle implants developed in the laboratory in people with advanced heart failure.