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3.26.2013

DRI Tests BioHub Mini Organ to Restore Natural Insulin Production in Type 1 Diabetes

New platform mimics native pancreas, contains real cells to normalize blood sugar in real time

Scientists from the University of Miami’s Diabetes Research Institute (DRI) are taking a quantum leap toward a biological cure for diabetes by unveiling the DRI BioHub, a bioengineered “mini organ” that contains lifesaving insulin-producing cells that can sense blood sugar and release the precise amount of insulin needed in real time. The BioHub platform mimics the native pancreas and brings the promise of restoring natural insulin production and normalizing blood sugar levels in millions of people living with diabetes one step closer to reality.

The DRI’s research focus has been on developing a biological cure for diabetes by replacing the insulin-producing islet cells that have been mistakenly destroyed by the immune system in patients with type 1 diabetes. Clinical trials have already shown that people with long-standing diabetes can achieve insulin independence after receiving infusions of islet cells from a donor organ. Some study patients continue to be insulin-free for more than a decade following transplant.

However, islet transplantation has been limited to only the most severe cases of diabetes and several challenges remain before the strategy can be offered to all who can benefit. The hurdles to be overcome include the need to take anti-rejection drugs for the rest of the patient’s life, the eventual need for a plentiful supply of insulin-producing cells for transplant, and the identification of an optimal site within the body to house the new cells. The BioHub is a platform that addresses these challenges by drawing on recent developments in bioengineering, immunology, and decades of transplantation expertise.

Prior to their destruction by the immune system in type 1 diabetes, healthy islets thrive inside the pancreas, where they have sufficient oxygen, adequate space, and all the nutrients needed to perform the demanding job of normalizing blood sugar levels. The BioHub attempts to closely replicate the natural cell environment and allows scientists to fine tune cellular needs within the transplant site as never before.

“The progress in islet transplantation has been incremental and has allowed us to get to this important juncture,” said Camillo Ricordi, M.D., Stacy Joy Goodman Professor of Surgery and Director of the Diabetes Research Institute. “The BioHub gives us a tool to combine all we’ve learned through the years of clinical testing and take the next leap forward. I am confident that this approach could move cellular therapies and biological replacement strategies for the cure of diabetes to our final goal.”

Among the platforms being tested for a BioHub is a porous, sponge-like material approximately the size of a quarter that is compatible with the human body. Islet cells are gently seeded on this protective platform, allowing cells to nestle within the individual pores. Researchers are also testing the use of more natural containers, such as a patient’s own vein, that can be tied off to create a “venous sac” complete with its own pre-existing vascular supply. In addition to housing transplanted insulin-producing cells, a BioHub also will allow scientists to enhance the immediate transplant environment with additional oxygen, specific types of “helper” cells, or other agents to promote the cells’ long-term survival and function. Additionally, a BioHub platform can be used to house not just islets, but any future insulin-producing cell type that scientists create.

Jay Skyler, M.D., Deputy Director of Clinical Research and Academic Programs at the DRI, said, “The development of a mini organ would mimic the native pancreas and restore the natural metabolic function of insulin release in immediate response to blood sugar levels — something currently unavailable to patients with diabetes.”

“If we can identify an optimal place within the body to place a BioHub, then I believe this disease is totally reversible, which has been the DRI’s ultimate goal since our inception,” adds Luca Inverardi, M.D., Deputy Director of Translational Research.

The components that comprise the BioHub are in various stages of development and testing, with pre-clinical trials underway.

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