First European clinical trial in human stem cell therapy for type 1 diabetes is underway

The development of encapsulation technologies to treat insulin-dependent diabetes has been at the forefront of type 1 diabetes (T1D) research in North America for many years. This is because new methods of cell delivery may offer a functional cure for people with T1D at high risk for life-threating complications.

Recently, the Center for Beta Cell Therapy in Diabetes, coordinator of an international consortium in translational medicine in diabetes, and ViaCyte Inc., a privately held regenerative medicine company, collaborated on their first European clinical trial involving human stem cell-derived implants among T1D patients.

Performed at UZ Brussel, the University Hospital of Vrije Universiteit Brussel (VUB), the pilot project saw participants receive ViaCyte’s product candidate, PEC‐Direct™, which delivers pancreatic cells in a device to individuals with severe hypoglycemic episodes, extreme changes in their glucose levels, and/or hypoglycemia unawareness. Upon maturation, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. The device not only replaces lost insulin-producing beta cells but also restores blood sugar control for T1D patients who are eligible for beta cell replacement therapy.

This work complements the clinical evaluation of PEC-Direct™ currently underway in North America. During the first phase of the European trial, implants will be evaluated for their ability to form beta (insulin-producing) cells; the second phase will examine their capacity to produce systemic levels of insulin that establish glucose control. The implantation in these first European patients is a major step in the development of cell therapies with the potential to cure T1D.

This trial, along with preclinical trials, was carried out by the Beta Cell Therapy Consortium with the support of a Horizon 2020 grant from the European Commission. The consortium is composed of clinical, industrial, and research teams at VUB, ViaCyte, San Raffaele Hospital Diabetes Research Institute in Milan, Nestlé Institute of Health Sciences in Lausanne, the University Medical Center in Leiden, and Institut du Cerveau et de la Moelle Epinière in Paris.

For more informative articles on health and type 1 diabetes, visit our JDRF Blog.

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