Unicyte, a regenerative medicine unit of Fresenius Medical Care, and its collaboration partner Professor Camussi have published results in Stem Cell Reviews and Reports that a potential therapeutic strategy for diabetes is the transplantation of induced-insulin secreting cells.
The Global Disease Burden of Diabetes Mellitus
Diabetes mellitus is one of the most common diseases globally. Diabetes mellitus (DM), commonly referred to as diabetes, is a group of metabolic disorders in which there are high blood sugar levels over a prolonged period. With an aging population and surging rates of obesity, the incidence of this debilitating disease on the rise.
According to the World Health Organization, an estimated 422 million adults were living with diabetes in 2014. This number represents a 4-fold increase since 1980 when there were only 108 million adults with the disease. The global prevalence (age-standardized) of diabetes has also nearly doubled since 1980, rising from 4.7% to 8.5% in the adult population.
According to the Center for Disease Control (CDC), 29.1 million people or 9.3% of the U.S. population has diabetes, including an estimated 8.1 million who are undiagnosed. The American Diabetes Association also reports that the cost of this disease in the U.S. is “$245 billion per annum or approximately $500,000 every minute.”
Cell Therapy Treatments for Diabetes
Fortunately, progress with cell therapy treatments for diabetes is being made by companies and institutions worldwide. There are now 14 companies exploring cell therapies treatments for diabetes, led by leaders that include Unicyte, Viacyte, Semma Therapeutics, Mesoblast, Sernova, Betalin Therapeutics, Orgenesis, and others.
Unicyte has a collaboration with Prof. Giovanni Camussi at the University of Turin, who discovered that Human Liver Stem Cells (HLSCs) are able to undergo differentiation into insulin secreting cells. ViaCyte differentiates stem cells into pancreatic beta cell precursors (PEC-01™) and subcutaneously implants them into patients using a retrievable medical device (an Encaptra® cell delivery system). Semma Therapeutics is commercializing technology from the laboratory of Professor Douglas Melton, who discovered a method to producing billions of functional, insulin-producing beta cells within a laboratory context.
Many other cell therapy approaches are being explored as well.
Human Liver Stem Cell Islet Like Structures (HLSC-ILSs)
Induced pluripotent stem cells (iPSCs) and human embryonic stem cells (hESCs) are potential cell sources for stem-cell derived islets and treatment of diabetes. However, the tumorigenicity of iPSCs and hESCs resulting from residual non-pancreatic cells and multi-step reprogramming procedures is a big concern for clinical translation.
The strategy of choice is encapsulation which requires intensive surgical interventions and several weeks of functional engraftment.
Mentioned previously, Unicyte is a regenerative medicine company headquartered in Oberdorf, Switzerland. It recently developed a one-step process leading to large quantities of islet like structures.
Known as human liver stem cell islet like structures, the short-hand for these cellular structures is HLSC-ISLs. Based on the common embryonic origin of liver and pancreas, it is reasonable that of adult human liver stem-like cells (HLSC) have the potential to generate in vitro insulin-producing 3D spheroid structures (HLSC-ILS).
Supporting Insulin Production and Reversing Hyperglycemia
According to recent research conducted by Navarro-Tableros, et al., in Stem Cell Reviews and Reports, spontaneous differentiation of adult human liver stem cells (HLSCs) into multi-hormonal and multi-cellular islet like structures is rapid and highly reproducible. Furthermore, subpopulation analysis indicates that remaining non-pancreatic cells are HLSCs that have been shown to be non-tumorigenic.
HLSC-ISLs are capable to restore a normo-glycemic profile as early as one week following transplantation in a murine model of Type 1 Diabetes Mellitus (T1DM). The rapid engraftment and function of HLSC-ISLs is further confirmed by near-to-normal glycemia levels under an intraperitoneal glucose tolerance test (IPGTT).
Titled, “Islet-Like Structures Generated In Vitro from Adult Human Liver Stem Cells Revert Hyperglycemia in Diabetic SCID Mice,” the authors conclude:
In conclusion, protamine-induced spheroid aggregation of HLSC triggers a spontaneous differentiation to an endocrine phenotype. Although the in vitro differentiated HLSC-ILS were immature, they responded to high glucose with insulin secretion and in vivo reversed hyperglycemia in diabetic SCID mice.
With these encouraging results, Unicyte is now evaluating options for clinical translation.
Unicyte, a regenerative medicine unit of Fresenius Medical Care
As a pioneer in liver stem cells and EVs, Unicyte is dedicated to improving the lives of patients with diabetes, as well as kidney, disease, liver disease, and cancer.
To learn more, view the full publication here: https://link.springer.com/article/10.1007%2Fs12015-018-9845-6
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