‘It literally saved my life’: Edmonton Protocol celebrates 25 years of success

The U of A’s islet transplantation program has revolutionized diabetes treatment — and researchers continue the quest to improve its life-changing impact for patients.

James Shapiro (Photo: John Ulan)

James Shapiro, who led the team that published the Edmonton Protocol 25 years ago, says he is proud of their work and the impact it has had. “More than anything, patients and their families have real, tangible hope of a better quality and longer life ahead.” (Photo: John Ulan)

Diabetes patients, researchers, donors and funders will gather this week at the Alberta Diabetes Institute to celebrate 25 years since the Edmonton Protocol was first published by a team of University of Alberta researchers in the New England Journal of Medicine. Edmonton’s islet cell transplant program has since grown into one of the world’s largest and most successful.

It was a life-saver for Yukon patient Rebecca Kalles Meng, now 61, who has lived with Type 1 diabetes since she was five years old. Her disease became increasingly difficult to control, and she would end up in hospital regularly. She could no longer live alone. 

Five years ago, she received two transplants of insulin-producing islet cells into her liver under the Edmonton Protocol.

“My whole world changed after the transplant. My blood sugars stabilized, and I no longer needed someone with me all the time,” says Kalles Meng. “I now have my own life, and I have freedom. It makes me feel so good. It literally saved my life.”

Before the Edmonton Protocol, 293 patients around the world had received islet transplants, but only eight per cent remained insulin independent. The U of A team focused on better ways to prepare sufficient islets, transplant without surgery and care for the patients afterwards, in particular developing a unique regime of anti-rejection drugs.

“The Edmonton Protocol evolved out of desperation as a last-ditch attempt, and honestly I did not think it would work!” recalls James Shapiro, professor of surgery, Canada Research Chair in Transplantation Surgery and Regenerative Medicine and lead author on the original paper. “When the seventh patient was insulin-free with excellent sugar control, it was clear we had something special — and strikingly different from what had gone before.”

“Today, more than 3,000 islet transplants have been carried out worldwide, and more than anything, patients and their families have real, tangible hope of a better quality and longer life ahead,” Shapiro says. “I am so proud of our clinical research team that made this happen and has made a difference.”

On March 11, 1999, Byron Best, a teacher from the Northwest Territories, became the first patient to receive a transplant following the new approach. Within a week, he no longer needed insulin injections. Six more patients soon followed, and the team knew they had a breakthrough. 

Since then, 330 patients have received nearly 750 transplants in Edmonton. 

“It’s impossible to overstate what a game changer this has been for people living with complex diabetes,” says Brenda Hemmelgarn, dean and vice-provost of the College of Health Sciences and dean of the Faculty of Medicine & Dentistry

“Edmonton’s clinical islet transplant program quickly became the world’s largest islet transplant program and cemented our reputation as a leader in diabetes research. Today, that work continues to grow and evolve.” 

The Edmonton Protocol evolved out of desperation as a last-ditch attempt, and honestly I did not think it would work! When the seventh patient was insulin-free with excellent sugar control, it was clear we had something special — and strikingly different from what had gone before.

James Shapiro

Members of the Clinical Islet Transplant Program. Top, from left: Greg Korbutt, Eddie Ryan and James Shapiro. Bottom, from left: Jonathan Lakey and Ray Rajotte.
(Photo: Members of the Clinical Islet Transplant Program team. Clockwise from top left: Greg Korbutt, Eddie Ryan, James Shapiro, Ray Rajotte and Jonathan Lakey. Photo by Richard Siemens)

The team continued to refine the protocol and published its 20-year results in The Lancet Diabetes and Endocrinology in 2022, demonstrating that 61 per cent of recipients were still insulin independent a year after their transplants, 32 per cent at five years and eight per cent after 20 years.

The Alberta Diabetes Institute’s 50-plus members continue to improve the protocol and develop better treatments for the more than 450 million people around the world who live with all types of diabetes.

“It’s important to mark this anniversary and celebrate the contributions from researchers, patients and donors that took an idea that seemed impossible and made it a reality,” says Peter Senior, professor of medicine, director of the Alberta Diabetes Institute and Charles A. Allard Chair in Diabetes Research

“Just as important is our anticipation of what’s coming next — taking lessons from the last 25 years to pave the way for the next generation of islet cell transplants using an unlimited supply of stem-cell-derived islets,” Senior says.

Work is underway to develop new sources of islet cells, which are currently only available from deceased donors. Other research focuses on ways to hide the transplanted cells from the immune system so recipients would no longer need to take lifelong anti-rejection drugs. Another clinical trial is identifying a drug that could reset the immune system of patients with newly diagnosed Type 1 diabetes to prevent the immune attack before it destroys all of the insulin-producing cells in the pancreas. Local patients are encouraged to help by participating in a variety of research studies

Rebecca Kalles Meng is not completely free of insulin injections five years after her transplant, and she experiences some side-effects from the immunosuppressive drugs she takes. But she says her overall improvement in quality of life has made these challenges worth it. 

“I dream of a future where islet transplants are more accessible to all patients living with diabetes, no matter where they live in Canada, and I’m particularly excited about the new advancements in stem cell research,” Kalles Meng says. “These procedures could revolutionize diabetes care, making it easier for many people with diabetes to live healthier lives.”

On June 4, 2025, the Alberta Diabetes Institute in partnership with the Gairdner Foundation will host a public event to celebrate the 25th anniversary of the landmark Edmonton Protocol publication. On June 5, the two partner organizations will host a scientific symposium to celebrate the 25th anniversary, featuring leading experts speaking on beta cell replacement therapy, autoimmunity and inflammation, and islet cell biology.