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New clinical trial could offer a ‘functional cure’ for people with type 1 diabetes

The ViaCyte trial is being run at three sites in North America, including University of Minnesota Health.
Greg Romero (right) has to live with his type 1 diabetes all day, every day. But a new clinical trial offered through University of Minnesota Health could give him a “functional cure” for his disease.

Greg Romero can’t run or hide from his type 1 diabetes.

“It’s the main priority I have, taking care of this disease,” he said. “Every minute of every day.”

Romero has been diabetic since he was 11 years old, but in the past several years his disease has become more complicated. He’s developed hypoglycemia unawareness, which means he’s not able to feel when his blood glucose drops to dangerously low levels. Even with new technology that routinely provides him insulin and monitors his blood glucose levels, managing his disease is an ever-present responsibility.

Now, there’s a sign of hope. Romero is one of a handful of people in the world participating in a new clinical trial that’s studying whether pancreatic progenitor cells, transplanted into a person with type 1 diabetes, can become cells that produce insulin naturally—effectively curing the disease. Developed by ViaCyte, the trial is available at three sites in North America, including University of Minnesota Health.

Pediatric Endocrinologist Melena Bellin, MD, and Transplant Surgeon Ty Dunn, MD, are leading University of Minnesota Health’s trial site.

New clinical trial is promising, doctors say

People without diabetes naturally produce insulin, which helps regulate blood glucose (sometimes known as blood sugar) levels. In healthy individuals, cell clusters in the pancreas known as “pancreatic islets” contain several types of cells, one of which naturally produces and releases insulin when the body needs it. In Romero and other type 1 diabetics, however, those insulin-producing islet cells are damaged or destroyed. That means their bodies cannot make insulin and they must constantly administer artificial insulin to keep their blood glucose in the normal range. If their blood glucose gets too low or too high, it can be fatal.

The trial replaces a patient’s destroyed or damaged islet cells with pancreatic progenitor cells. These manufactured progenitor cells are transplanted into a patient with type 1 diabetes. Once transplanted, doctors hope the cells will develop into islet cells and begin producing insulin on their own, taking over the role of a patient’s damaged or destroyed islet cells. So far, researchers have successfully transplanted islet cells from deceased donors, but there are limits to that method, Dunn said.

Learn more about University of Minnesota Health diabetes care.

“These pancreatic progenitor cells are a renewable resource. A single progenitor cell source can potentially be used to treat thousands of patients with type 1 diabetes,” Dunn said. “For this reason, we don’t have to wait for a scarce organ donor.”

As part of the trial, Dunn transplanted several “pods” into Greg Romero. These pods contain the immature pancreatic progenitor cells that will eventually become insulin-producing cells.

“We hope these implants could help patients produce insulin normally so that people with type 1 diabetes could be protected from hypoglycemia unawareness and may no longer need to take insulin,” Dunn said. “For a diabetic that depends on insulin injections to live, this could be a game changer.”

Interested in receiving information about future islet cell studies at the University of Minnesota, or potentially participating in a clinical trial? Register using our secure form.

A “deeply personal” disease

Type 1 diabetes is part of Romero’s everyday life, but that’s not usually apparent to many people around him.

“That’s just the reality of the disease. It’s pretty invisible,” he said. “People can’t look at me and see [my diabetes]. I don’t look sick, but I could feel like I’m dying.”

The prospect of reducing or even eliminating the need for regular insulin injections is exciting for Romero, who is the second patient enrolled in the clinical trial at University of Minnesota Health. To enter the trial, patients must be diagnosed with type 1 diabetes and be completely dependent on insulin to control their diabetes. They also must have hypoglycemia unawareness or other high-risk conditions associated with type 1 diabetes.

Romero will have some of the insulin-producing pods in him for the next two years. Bellin and Dunn will constantly monitor him and other patients during that time to see whether the pancreatic progenitor cells fully mature and begin to naturally produce insulin.

For Romero, the disease is deeply personal. His father, who also had type 1 diabetes, fell into a hypoglycemic coma for 10 days over a decade ago. Afterward, he became severely cognitively impaired and remained that way until he passed away last year.

Because Romero has hypoglycemia unawareness, he doesn’t experience the usual symptoms—shakiness, sweatiness and confusion—when his blood glucose levels plummet. Several times, he said, his wife has had to call an ambulance because his blood glucose levels were too low and he wouldn’t wake up.

The trial, Romero said, is making him cautiously optimistic that things that could change.

“That’s why I’m really excited about being in this study, so that I can help this team help other patients with Type 1 diabetes and hypoglycemia unawareness,” he said. “This could really help save people like me and my dad.”