GMP-Production of Engineered Human Myocardium for Heart Failure Repair
- Förderkennzeichen
81X2300176
- Projektnummer
884
- Institution
- Georg-August-Universität Göttingen - Universitätsmedizin
- Projektleiter
- Wolfram-Hubertus Zimmermann
- Standort
- Göttingen
- Kurzbeschreibung
-
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 …
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.
- Projektart
- Translational Research Project
- Fördersumme
- € 2.654.615,00
- Beginn
- 08.01.2018
- Ende
- 30.06.2022