A "patch for the heart" made from stem cells could potentially cure heart failure.

A study conducted at the Göttingen University Medical Center (UMG) and the University of Schleswig-Holstein Medical Center, Lübeck Campus (UKSH) marks a significant milestone for the clinical application of the "heart patch" as an innovative treatment method for patients with progressive heart failure. The results of the study have been published in the journal Nature.

Within the clinical trial BioVAT-HF-DZHK20, a unique approach to addressing the unmet medical needs of patients with progressive heart failure is being investigated. The implantation of a tissue-engineered heart patch, referred to as engineered heart muscle (EHM), is designed to restore the weakened heart.

The EHM patch consists of lab-grown heart muscle made from induced pluripotent stem cells embedded in a collagen hydrogel. The foundation for transitioning to clinical trials was established through modeling clinical treatments on rhesus macaques. To date, the EHM patch is the only technology that ensures safe and effective delivery and 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 leader of the preclinical and clinical studies of the heart patch, along with colleagues from UMG and UKSH, successfully implanted the so-called “patch-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 documented evidence of the safety and efficacy of the heart patch application in rhesus macaques. Modeling of clinical applications on rhesus macaques at the German Primate Center — Leibniz Institute for Primate Research was essential for collecting convincing data to support use in humans.

The researchers demonstrated that 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 were retained while simultaneously suppressing the immune response and enhancing the heart's pumping function.

“We have shown in rhesus macaques that the implantation of heart patches can be applied for the remuscularization of a failing heart. The challenge was to generate and implant a sufficient number of heart muscle cells from induced pluripotent stem cells of rhesus macaques to achieve sustainable heart recovery without dangerous side effects such as cardiac arrhythmia or tumor growth,” explains Professor Zimmermann.

The research results now being reported were a decisive factor for the approval of the world's first clinical trial for heart recovery using lab-developed tissue-engineered heart muscle implants in individuals with progressive heart failure.