GMP-production of engineered human myocardium for heart failure repair

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

Results

The patches developed in the project were used to start the BioVAT-HF-DZHK20 clinical trial, which is funded by the DZHK clinical trials program. (press release: Start of First Clinical Trial on Tissue Engineered Heart Repair, 9.2.2021)