Dr. James Shapiro

Dr. James Shapiro, MD, University of Alberta

A packet of relief for type 1 diabetes

More than 300,000 Canadians live with type 1 diabetes, a disease in which the body lacks insulin, a hormone needed to take up energy in the form of sugar from the blood. Insulin is normally produced by the beta cells in the pancreas, but in type 1 diabetes, the immune system attacks and kills these cells, preventing the body from effectively regulating blood sugars. Without treatment, type 1 diabetes is life-threatening, however blood sugar monitoring, injections of insulin several times a day and careful meal planning can keep patients alive. But it is not a cure. Over a lifetime the costs, in terms of medical treatments as well as quality of life, are considerable. In addition, diabetes is the leading cause of kidney failure, non-traumatic limb amputations, and new cases of blindness in adults.

Dr. James Shapiro, a surgeon at the University of Alberta, was the lead on The Edmonton Protocol, which found that transplanting islets from donors could effectively improve outcomes for high-risk type-1 patients. His team has performed over 600 islet transplants in the last two decades, and this protocol has been implemented worldwide in over 2,000 patients at more than 30 international institutions. However, the shortage of donor islets presents a great problem for helping this treatment reach the many more patients in need.

In search of a long-term, curative solution for type 1 diabetes, the Stem Cell Network is supporting a clinical trial led by Shapiro that aims to test whether an implantable device can allow a successful and long-term graft of beta cells for functional recovery. Shapiro has assembled a multidisciplinary team that includes clinicians, researchers and industry leaders with expertise in type 1 diabetes and in health economics

The beta cells used for transplant in the study will be grown from stem cells, using a protocol devised by the US-based regenerative medicine company ViaCyte. Shapiro and his team have participated as partners in previous clinical trials using ViaCyte’s technologies. This industry partnership ensures cells and the delivery methods can be made reliably and consistently at the high volumes that would be necessary if this were to become a standard of care.

In this new study, Shapiro’s team will be testing more recent improvements to the cell delivery technology – a type of capsule implanted under the skin – that he hopes will provide a better and removable platform for the transplanted cells to thrive on until such time as they are fully integrated and functioning in the patient.

Thanks to support from the Stem Cell Network, Shapiro hopes to bring his work one step closer to a sustainable, scalable solution to advance future care of the millions of people worldwide with diabetes.

James Shapiro’s project is part of the 2018-19 Clinical Trials Program providing $1.5M for three clinical trials. A total of 33 investigators (7 Investigators and 26 Collaborators) at nine institutions and 27 trainees will be engaged in these trials, which will determine the safety and efficacy of new stem cell treatments in humans. This program supports phase I/II trials with the potential to be economically viable for health care systems and show a benefit to patients. Funded trials will focus on evaluating a stem cell therapy for diabetes, using expanded stem cells from cord blood in the treatment of multiple myeloma and assessing an enhanced cell therapy for heart repair.

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