The Center undertakes multicenter clinical trials that are driven by the R&D platform. Our clinical program intervenes at various stages of the disease progression:
1. Screening for Disease Risk
Diagnosis of type 1 diabetes is preceded by a phase without symptoms that can last for several years and during which early markers may be found in the blood. Screening of first degree relatives of people with type 1 diabetes has led to the identification of distinctive risk groups. Identifying people at risk of developing the disease or diagnosing it earlier can greatly improve the treatment of type 1 diabetes. The Center for Beta Cell Therapy in Diabetes is developing and refining biomarkers that can be used for screening, classification and treatment of diabetes patients, as well as selection for innovative intervention trials.
More information from Belgian Diabetes Registry
2. Transplantation of Stem Cell-Derived Progenitors
As the most promising source for beta cell replacement strategies, stem cell-derived pancreatic cells have now entered the phase of clinical translation. The Center for Beta Cell Therapy in Diabetes will conduct a study with ViaCyte’s cell therapy product PEC-Direct™ . It consists in human embryonic stem cell-derived pancreatic progenitors that encapsulated in a device that allows direct vascularization of the implant. This product is currently being tested in the USA and in Canada and has been approved for a phase 2 study in Belgium. It is meant to be tested in type 1 diabetes patients that are at high risk for acute complications, including coma and death. The specific aims of the trial will be to evaluate survival and differentiation capacity of the cell therapy product, and to identify biomarkers associated with clinical outcome. Parallel studies in preclinical models
will be performed to help in the analysis of the results obtained in patients and to identify treatments or procedures susceptible to improve graft outcome.
3. Transplantation of Islet Cell Preparations
Our clinical transplantation trial has identified conditions under which human beta cell implants help achieve glucose control in type 1 diabetic patients. A functional graft results in stabilization of glucose levels, freedom from severe hypoglycaemia and in about half of the implant recipients, complete withdrawal of need for insulin injections. However this procedure is limited by the shortage in human donor organs from which grafts can be prepared.
More information from Belgian Diabetes Registry
4. Preservation of Pancreatic Beta Cells
In type 1 diabetes the immune system destroys the pancreatic beta cells resulting in a loss of insulin production. At the moment of diagnosis, beta cells are still present but their number and function are insufficient to maintain normal glycose levels. Preservation of remaining pancreatic beta cells in type 1 diabetes patients can minimize risk for future complications. The Center for Beta Cell Therapy has shown that patients receiving an anti-CD3 antibody targeting the immune system required less insulin injections to maintain a normal glycemia. This promising study confirmed the important role of the immune system in type 1 diabetes and has stimulated many other immune intervention studies in type 1 diabetic patients worldwide.
More information from Belgian Diabetes Registry
ViaCyte’s PEC-Direct™ product is composed of stem cell-derived pancreatic tissue encapsulated in a device that allows direct vascularization. Image courtesy of ViaCyte.
Human islet cell preparations as used for clinical transplantation protocols. Endocrine cells are stained in blue.