“Through the establishment of a strong R&D platform for manufacturing of human pluripotent stem cell-derived pancreatic islet cells for future stem cell-based cell therapy of patients with severe forms of T1D, the cooperation offers a unique opportunity for advancement of translational stem cell diabetes research and therapy.
Diabetes is one of the primary worldwide health challenges. Patients with T1D suffer from a destruction of insulin-producing cells of the pancreas. There is currently no cure for the disease; however, cell therapy in the form of pancreatic islet transplantation can prevent uncontrolled fluctuations of blood sugar levels in patients with a severe form of the disease.
The ability of human pluripotent stem cells to self-renew and differentiate into pancreatic islet cells offers a unique, exogenous scalable source of islet cells for such cell therapy in T1D. Human pluripotent stem cell-derived insulin-producing beta cells have yet to be transplanted into patients, and the new collaboration between the University of Copenhagen and Helmholtz Zentrum München provides the essential steps to the first clinical trial.
A platform for translational research
The key element of the new alliance is a platform for translational research associated with the manufacture of cells, in a ‘Good Manufacturing Practice’ (GMP)-dedicated facility in Munich. This platform will provide scalable GMP-grade cell production, regulatory expertise, and the testing of stem cell-derived insulin-producing cells, thereby establishing an optimal, complementary arrangement for translational research and accelerating the planning of the first-in-man clinical trial using human pluripotent stem cell-derived insulin-producing beta cells.
“We believe that we are well on track with our efforts to develop a stem cell-based replacement therapy and that our latest breakthroughs will pave the way for initial clinical trials in patients with severe forms of T1D. It is all the more important for us to exchange ideas with other top diabetes researchers, and we are therefore delighted to be connected with Helmholtz Zentrum München – a beacon of excellence in diabetes research,” says Professor and Executive Director of DanStem Henrik Semb.”