Diabetes Research Institute Foundation
Mission Statement
The mission of the Diabetes Research Institute Foundation is to provide the Diabetes Research Institute with the funding necessary to cure diabetes now.About Us
The Diabetes Research Institute Foundation is the organization of choice for those who are serious, passionate, and committed to curing diabetes. Its mission – to provide the Diabetes Research Institute (DRI) with the funding necessary to cure diabetes now – is a testament to the belief that tomorrow is not soon enough to cure those living with diabetes.The Diabetes Research Institute at the University of Miami Miller School of Medicine leads the world in cure-focused research. As the largest and most comprehensive research center 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.
Researchers have already shown that diabetes can be reversed through islet transplantation, with some study patients living without the need for insulin injections for more than a decade. The Institute is now building upon these promising outcomes by developing the DRI BioHub, an integrated “mini organ” that mimics the native pancreas, containing thousands of insulin-producing cells that sense blood-sugar levels and release the precise amount of insulin needed in real time.
The Diabetes Research Institute and Foundation were created for one reason – to cure diabetes – which is and will continue to be its singular focus until that goal is reached. For the millions of children and adults affected by diabetes, the Diabetes Research Institute is the best hope for a cure. For more information, visit DiabetesResearch.org or call 800-321-3437.
Pilot Clinical Trial will Test a New Site in the Body for a DRI BioHub Platform
In 2013, the Diabetes Research Institute and Foundation announced the next step in our approach to discover a biological cure by developing a DRI BioHub – a bioengineered “mini organ” that mimics the native pancreas, containing real insulin-producing cells that sense blood sugar and release the precise amount of insulin needed, in real time, together with critical components that keep the cells safe, healthy and functioning long term. The BioHub is a platform approach that builds upon decades of progress in clinical islet transplantation and holds the promise of achieving a practical cure by restoring natural insulin production in millions of children and adults living with diabetes. Over the last year, DRI Director Dr. Camillo Ricordi and his team have been investigating an optimal location within the body to house a BioHub. Currently, islets are transplanted into the liver, but that site is not an ideal home for the cells. One area of focus is the omentum, an apron-like lining inside the abdomen. DRI researchers believe that the omentum may be an ideal location for a BioHub. “The omentum is a very vascularized tissue that is easily accessed surgically and, most importantly, has the same blood supply and drainage characteristics of the pancreas,” said Dr. Ricordi. Encouraging preliminary data in experimental and pre-clinical models has shown that islets in the omentum can engraft and improve blood glucose control. “We have observed long term-survival and function of the islets in this site,” said Dr. Dora Berman-Weinberg, a member of the DRI’s Cell Transplant Center, who conducted these experiments with Dr. Antonello Pileggi, director of Preclinical Cell Processing and Translational Models, and their respective teams. "We were able to establish and optimize a protocol for implanting islets onto the surface of the omentum. Preliminary islet transplantation studies in experimental models of diabetes confirmed the feasibility of this approach," said Dr. Pileggi. This exciting research is now moving to patient trials. The DRI has received approval from the Food and Drug Administration to proceed with a Phase I/II clinical trial that will test the omentum as a possible transplant site for a DRI BioHub. In this pilot trial, researchers will transplant insulin-producing islet cells within a “biodegradable scaffold,” one of the approaches considered for a BioHub platform. The biodegradable scaffold is a combination of a patient's own plasma and thrombin, a commonly used, clinical-grade enzyme. When combined, these substances create a gel-like material that sticks to the omentum and holds the islets in place. This section of the omentum will be folded over and stitched, creating a pouch around the biodegradable scaffold mixture. Over time, the body will absorb the gel, leaving the islets intact, while new blood vessels are formed to support their survival and function. This pilot trial will include the immunosuppressive regimen currently used for clinical islet transplantation studies. “This is a very important first step in the overall development of the BioHub because this will set the site of implantation and the platform technology. We have to show initially that this transplant can function and be equivalent to the liver as a site of implantation,” explains Dr. Ricordi. “We will then add all the other components that will favor new blood vessel development, oxygen generation, cell protection and other agents that will allow us to reduce and eventually eliminate systemic immunosuppression, which is our goal for a biological cure.” The DRI also plans to test another BioHub platform – a “bioengineered scaffold,” a sponge-like disc made of clinical-grade silicone – also utilizing the omentum as a transplant site. Researchers are in discussions with the FDA about additional pre-clinical testing that the regulatory agency has required before approval of that pilot clinical trial in the U.S. can be granted. “We will test both the biodegradable scaffold and the bioengineered scaffold to see which approach is better and demonstrates greater benefits for patients with diabetes. Both approaches will allow us to add all the components necessary for developing a BioHub mini organ,” adds Dr. Ricordi. For more information on the pilot trial and to download the Islet Transplantation Application form, please visit DiabetesResearch.org/PilotTrial. The DRI has also made progress in the other strategic areas comprising the BioHub, which include methods to protect the insulin-producing cells from the immune system, as well as a means of developing an unlimited supply of cells. You can read more about the DRI’s research progress at DiabetesResearch.org/AnnualReport.
The Iacocca Foundation Awards Grants to DRI Scientists for Innovative Research
The ability to stop the immune system from attacking pancreatic islet cells is critical for restoring natural insulin production and reaching a biological cure for diabetes. Thanks to recent grants awarded by The Iacocca Foundation, two of the DRI's scientists who are making important inroads in this critical area will be able to continue their innovative research toward this goal. Dr. Alice Tomei, research assistant professor of surgery and member of the DRI's bioengineering team, is investigating ways that cancerous tumors evade destruction by the immune system with the goal of using that "escape mechanism" to protect insulin-producing cells. Dr. Tomei and her team have published key findings in the journal Science demonstrating that tumors secrete the molecule CCL21, which is naturally found in lymph nodes as mechanism of self protection. Armed with this important information, the team has performed additional studies and has found that CCL21 expression in beta cells (the insulin-producing cell component within islets) completely prevents type 1 diabetes in experimental models. The funding award from The Iacocca Foundation will allow Dr. Tomei to build upon this groundbreaking research. Dr. Peter Buchwald, director of drug discovery, is targeting a recently-identified signaling pathway that leads to autoimmune destruction of insulin-producing cells. He and his team have had promising results in experimental models demonstrating that new-onset diabetes can be reversed by blocking this pathway with a protein known as Smad-7. There is also scientific evidence supporting his theory that the use of Smad-7 not only controls the autoimmune destruction of the islet cells, but can also lead to islet regeneration. With the funding from The Iacocca Foundation, Dr. Buchwald and his team will focus on investigating the possible beta cell-enhancing effects of this treatment with the goal of quickly translating this research to clinical therapies.
Diabetes Researchers Develop a New Cell Encapsulation Method to Protect Transplanted Insulin-Producing Cells
Researchers believe that the novel approach offers major advantages over traditional encapsulation strategies Scientists at the Diabetes Research Institute (DRI) in Miami together with collaborators at the Ècole Polytechnique Fèdèrale de Lausanne (EPFL) in Switzerland have developed a new cell encapsulation method with the goal of protecting transplanted insulin-producing islet cells from destruction by the immune system. Their novel process for conformal coating of islets (similar to applying a tight-fitting “shrink wrap” around the cells) with thin, complete and uniform capsules of similar thickness, has been designed to specifically address what are considered to be the limitations of traditional cell encapsulation methods. The results of their recent study, which demonstrates that their unique conformal coatings allows efficient encapsulation of islets without compromising viability and function of the cells, were recently published in the prestigious journal Proceedings of the National Academy of Sciences. The encapsulation of islet cells has been researched extensively as a potential therapy for type 1 diabetes. However, there has been limited success in translating this approach to patients due to a number of issues, including the size of the capsules themselves, the materials used to coat the cells, and the inability to transplant encapsulated islets in sites that favor oxygen and nutrient support to the transplanted cells to keep them healthy and functioning long term. The new process developed by the research team overcomes these critical challenges. “Previous efforts in islet encapsulation have failed partly because of the large size of conventional capsules,” said Alice Tomei, Ph.D., assistant professor of surgery and cell transplantation at the DRI, principal investigator and lead author of the published paper. “Islets vary considerably in size and shape, and production of traditional capsules is standardized to accommodate the largest size. This results in capsules that are too large for the smaller islets. The extra space inside the capsule delays access to oxygen and nutrients, causing many islets to die. It also delays the islet’s main function — sensing blood glucose and releasing the right amount of insulin in real time to avoid hyper- and hypoglycemia. Finally, such a large islet size does not allow implantation in sites that are more islet-friendly, and within devices that have been designed to house the islets in the manner that is most favorable for their function, like the BioHub." In the study, Dr. Tomei and her team observed that the conformal-coated islets exhibited no delay in glucose-stimulated insulin release and there was no loss of function when the cells were placed in culture prior to transplantation, which is often observed with non-coated, or naked, islets. When transplanted into experimental syngeneic models of type 1 diabetes, the conformal-coated islets restored normal glucose levels and maintained those levels for more than 100 days with no apparent signs of chronic site reactivity to the implanted capsule material. In addition, because the conformal-coated cells do not take up the same amount of space as the conventional larger capsules, researchers will be able to implant these coated cells within a confined site, like a DRI BioHub mini-organ. The research began several years ago, when Dr. Tomei was working at the Institute of Bioengineering at the EPFL in Switzerland in the laboratory of Jeffrey A. Hubbell, Ph.D., the article’s senior author. She came to the DRI in 2010, bringing the research with her. “Pancreatic islets are the most sensitive cells that I have worked with, and keeping them functional while enclosing them in a protective bubble has proved to be very challenging,” said Tomei. The scientists will continue to optimize their unique cell encapsulation process with the goal of translating this research to people living with diabetes. # # # Funding for the research was provided by the Diabetes Research Institute Foundation, JDRF-Helmsley, Children with Diabetes Foundation, the National Institutes of Health (NIH), BioRep Technologies, and Converge Biotech.
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