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 götting IG-Hostein, Canpus Lübek (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 Fail. 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-road heart muscle made up of induced pluripotent stem cell-directed 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 efficious delivery with long-term retection 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 (UNIVERITY MEDERATY CETER Al Heart Patch Studies, Togeether with Colleagues from the Umg and Uksh, have successfully Implanted the so-called “Heart Patch” in Patients with Heart Fail 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 rahsus macaques. The simulation of the clinical application in Rhesus macaques at the German Primate Center – Libniz Institute for Primate Research (DPZ) was essential to Gather Compeling Data to Suppport 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 Strenched 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 enough cells from freed Uripotent 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 report with tissue enginered heart muscle implants Eart failure.

Provided by universitätsmedizin göttingen-Georg-August-universität