Type 1 Diabetes BioHub Trial Patient is Living “Insulin-Free”


On August 18th, 2015, Wendy Peacock underwent the first-ever BioHub transplant–a minimally invasive procedure to place a “bioengineered mini-organ that mimics the native pancreas to restore natural insulin production” in people with type 1 diabetes.

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Wendy Peacock, now age 43, has lived with type 1 diabetes since she was 17 years old–andshe is now living “insulin-free” with perfect non-diabetic blood sugar levels nearly two months since the procedure.

The Diabetes Research Institute (DRI), a Center of Excellence at the University of Miami Miller School of Medicine, launched this pilot study, to test their transplant technique for insulin-producing cells–islet cells–after decades of research and development on clinical islet transplantation. This first-ever human trial is a tremendous leap forward in the development of the DRI BioHub.

“The first subject in our Phase I/II pilot BioHub trial is now completely off insulin with an excellent glucose profile. These are the best post-transplant results we’ve seen in an islet recipient,” said Camillo Ricordi, MD, director of the DRI and the Stacy Joy Goodman Professor of Surgery, Distinguished Professor of Medicine, Professor of Biomedical Engineering, Microbiology and Immunology at the University of Miami Miller School. Dr. Ricordi also serves as director of the DRI’s Cell Transplant Center.

“This was the first tissue engineered islet transplant using a ‘biodegradable scaffold’ implanted on the surface of the omentum,” explains Dr. Ricordi. “The technique has been designed to minimize the inflammatory reaction that is normally observed when islets are implanted in the liver or in other sites with immediate contact to the blood. If these results can be confirmed, this can be the beginning of a new era in islet transplantation. Our ultimate goal is to include additional technologies to prevent the need for life-long anti-rejection therapy.”

The omentum, explains the press release, is a “highly vascularized tissue covering your abdominal organs.

“The donor islets were implanted within a biodegradable scaffold, one of the platforms for a DRI BioHub, made by combining the patient’s own blood plasma with thrombin, a commonly used, clinical-grade enzyme,” explains the press release. “Together, these substances create a gel-like material that sticks to the omentum and holds the islets in place. The omentum is then folded over around the biodegradable scaffold mixture. Over time, the body will absorb the gel, leaving the islets intact, while new blood vessels are formed to provide critical oxygen and other nutrients that support the cells’ survival.”

One of the hardest parts of any type of transplant is suppressing the recipient’s body natural protective response from attacking the transplanted organ, or in this case, incredible man-made organ. For the BioHub, immunosuppressive therapy will be used in the study, but not all of the patients involved will receive immunosuppressants.

“As any type 1 knows,” says Wendy Peacock, groundbreaking BioHub recipient, “you live on a very structured schedule. I do a mental checklist every day in my head…glucose tabs, food, glucometer, etc., and then I stop and say, ‘WOW! I don’t have to plan that anymore.’ Laying down at night and going to sleep and not having to worry about lows is something that is so foreign to me. It’s surreal to me…I’m still processing the fact that I’m not taking insulin anymore.”

Peacock became a potential candidate for the DRI’s clinical trial because ofsevere hypoglycemia unawareness–“a complication of diabetes in which patients are unable to sense that their blood glucose is dropping to dangerously low levels,” explains the press release.

“We’re quite excited. This has been the best outcome we have seen at this stage. It’s a unique site, the surgery is very simple and the patient recovers very quickly. We will continue until our final goal–islet transplantation without immunosuppression,” says Rodolfo Alejandro, MD, Professor of Medicine and director of the DRI Clinical Cell Transplant Program.

In people with type 1 diabetes, islet cells are produced by the pancreas and continuously destroyed by the immune system. While islet cell transplantation is not a new approach to curing type 1 diabetes, it has yet to become an approach that could truly be applied to the larger population of people with type 1 diabetes.

“Islet transplantation has allowed some patients to live without the need for insulin injections after receiving a transplant of donor cells. Some patients who have received islet transplants at the DRI have been insulin independent for more than a decade,” explains the press release.

Another reason past approaches to islet cell transplantation has been unsuccessful is become they have always been “infused into the liver,” despite the fact that many of the cells are unable to survive in that location.

“The liver is a very simple site to access, but we have known for years that it’s not the ideal site. And the liver will not accommodate a device for housing the islets,” explained Dr. Alejandro.

The DRI continues to lead the way in cure-focused research as the largest and most comprehensive research center completely dedicated to curing diabetes. “The DRI is aggressively working to develop a biological cure by restoring natural insulin production and normalizing blood sugar levels without imposing other risks,” explains the press release.

“Researchers have already shown that transplanted islet cells allow patients to live without the need for insulin therapy. The DRI is now building upon these promising outcomes by developing the DRI BioHub and is testing various BioHub platforms in preclinical and clinical studies.”

For those who were diagnosed with type 1 diabetes even just a decade or two ago, the idea of a biological cure seemed like a distant dream. Today, that possibility grows more and more real by the day.