Effect of Encapsulated Human Islet Cells Implantation on Insulin Dependency in Diabetes Mellitus: An Innovative Approach

Abstract

Background: Globally, the number of diabetic patients has quadrupled in last 30 years and diabetes mellitus (DM) is among the major causes of death with rank 9 worldwide. Approximately there is 1 patient with DM in 11 people worldwide. Asia is among the major areas of where T2DM is rapidly emerging into global epidemic. In Asian countries China and India are top two epicenters for this rapidly emerging epidemic. Studies have shown that without immunosuppression in diabetic animal model, normoglycemia is maintained after implantation of encapsulation technique (macro/micro-encapsulation) containing islets at different sites in body. If this study could work well, it will be possible to implant a capsule in diabetic patient reducing dependency on insulin from outside using other methods like multi-layer-by-layer encapsulation. Purpose of this study will be to determine whether encapsulation of pancreatic β-cell in subcutaneous region could protect human islets from rejection and autoimmune destruction in diabetic patients, by overall decreasing insulin dependency in T2DM patients without immunosuppression. Methods and analysis: Protocol will be based on multi-layer-by-layer encapsulation procedure. Discussion: To our knowledge, there are no such studies which are performed in phases making this study to be a best example of evidence based protocol. Appropriate subgroup analysis has been planned while performing animal experimentation. Routine postoperative monitoring have been planned to ensure Ethics and dissemination. Analysis of encapsulation in different conditions i.e. in-vitro and in-vivo will provide diverse data on effects of encapsulated islet cells on different environmental conditions. In-vitro data will be compared with in-vivo data in order to find out detailed successful results. According to this protocol, if we will be able to develop encapsulated human islet cells that will produce insulin and decrease insulin dependency then this study will be a novel interventional research to decrease burden of insulin therapy in low income population such as of India.