GMP-Production of Engineered Human Myocardium for Heart Failure Repair

Irreversible and progressive loss of cardiomyocytes is the underlying cause of heart failure. Remuscularization of the failing heart can be achieved by epicardial implantation of tissue engineered myocardium. A major procedural challenge for the translation of cell based therapies is the set-up and validation of a cGMP-production process. This should be done early during the translation process to reduce costs and variability/inconsistency already in preclinical studies and facilitate clinical translation into first-in patient studies. We have developed a versatile protocol for the construction of engineered human myocardium from ESCs and iPSCs to meet cGMP demands. The objectives of this project are to now set-up a GMP production pipeline and obtain a manufacturing authorization from the local competent authority for the preparation of EHM for a first in patient safety study with an anticipated number of 10 patients with end-stage heart failure.