Today there are about 60 M people with diabetes in the EU. Type 1 Diabetes (T1D) patients must cope with a lifetime of intensive self-care (testing their blood sugar levels several times a day to inject insulin when required) and the risk of premature death. Even with careful management patients can still have difficulties keeping a steady blood glucose level and over time these life-threatening fluctuations, especially the chronic high blood sugar levels (hyperglycemia), can cause serious complications including heart disease, blindness, kidney failure and limb amputations due to nerve damage. Islet transplantation is a novel technique which while effective is not a scalable therapy and limited to only the most severe T1D cases due to the shortage of cadaveric donor islets. Recent advances in generating insulin producing beta cells from pluripotent stem cells (hPSCs), positions stem cell-based therapy as a promising treatment for a wider population of T1D patients. A stem cell-based therapy would replace the damaged beta cells in the patients and allow for a natural production and secretion of insulin to regulate the blood glucose levels. To make stem cell therapy a clinically and commercially viable treatment in diabetes, the following technical hurdles need to be addressed: safety (lack of purity), cost-effective scalability, and lack of immune protection of the implanted cells.
PanINSULA, in contrast to other available competing technologies, addresses all these issues enabling both purification and automation. This ensures unparalleled safety with cost-efficient scalability and manufacturability of the final cell product.