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Patent Awarded for Replacement Pancreas Cell Processes

U.S. Patent and Trademark Office

U.S. Patent and Trademark Office (A. Kotok)

6 November 2014. ViaCyte Inc., a biotechnology company in San Diego, received a patent for its processes in making early stage pancreatic cells to replace defective cells in patients with type 1 diabetes. Patent number 8,859,286 was awarded in mid-October by U.S. Patent and Trademark Office to inventor Alan Agulnick, a researcher at ViaCyte, and assigned to the company.

Type 1 diabetes is a chronic condition where the pancreas makes no or very little insulin, a hormone that enables glucose or sugar to produce energy. The disorder can be inherited or aggravated by environmental factors, but the body’s immune system begins destroying islet cells in the pancreas, called beta cells, that produce insulin.

About 5 percent of the 29 million Americans with diabetes have type 1 diabetes. People with type 1 diabetes must replace the insulin missing from their pancreas, or face life-threatening consequences from the build-up of glucose in the bloodstream. Patients with the disorder must constantly monitor their blood glucose levels, and inject insulin with a syringe or wear an insulin replacement pump.

ViaCyte’s lead product is a system called VC-01 that produces and delivers insulin with an artificial pancreas. In the system, insulin is made with replacement beta cells, derived from cultured human stem cells. The replacement beta cells, in an early precursor state similar to their natural counterparts, are contained in a device implanted under the skin of the patient, where they develop into mature beta cells and produce insulin. The system, says ViaCyte, also enables the development of blood vessels to provide oxygen for the growth of mature beta cells and distribution of insulin to the body.

The patent covers the company’s processes for deriving precursor beta cells from human stem cells. The processes describe the cultures and agents employed to differentiate stem cells into precursor beta cells, as well as alternative methods covering the use of both human embryonic stem cells and adult induced pluripotent stem cells.

ViaCyte is testing the safety and efficacy of its VC-01 system in a clinical trial enrolling up to 6 patients with type 1 diabetes. The company says it implanted the first VC-01 device as part of this study in late October.

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