This is the fifth in a series of reports on the top five largest T1D research centers in the U.S. It features a profile of the Diabetes Research Institute (DRI) at the University of Miami. In addition to an overview of the organization itself, these reports also examine the current research and research spending at the University.
In 2013, the DRI combined its T1D cure research under an umbrella strategy called the "BioHub” initiative. The overreaching aim of the Biohub is the discovery of a biological cure for diabetes. Research within the DRI focuses mainly on the BioHub initiative.
HISTORY AND OVERVIEW
The University of Miami Leonard M. Miller School of Medicine was founded in 1952 and includes three hospitals and more than thirty outpatient facilities throughout Florida. The Diabetes Research Institute, which began as a small research program at UM's medical school in 1971, is currently led by Dr. Camillo Ricordi, who has served in this capacity since 1993.
The DRI receives funding from multiple sources, including the University of Miami and the Diabetes Research Foundation (DRIF), a non-profit fundraising foundation founded in 1971 with the sole mission to fund the DRI. The organization raises money through private philanthropy, corporate sponsors, and fundraising events. The DRIF has raised hundreds of millions of dollars for the DRI, and roughly half of the annual funding for the DRI comes from the Foundation. This structure is unique and is a key reason why the DRI has been able to maintain its focus on T1D cure research, as opposed to prevention and treatment specific projects as many other academic research centers have done.
In 2015, the most recent year of available data, University of Miami had a total T1D research budget of $15.5 million, $10.8 million (69.7%) of which came from the Diabetes Research Institute Foundation (DRIF), discussed in more detail below. $5.2 million was given through NIH grants and $2.1 million was given through JDRF grants. In 2015, UM received 15 NIH research grants and 9 JDRF research grants.
The Biohub is meant to identify research strategies which effectively mimic the pancreas by encapsulating insulin-producing cells that can sense blood sugar and release the specific amount of insulin necessary to normalize blood sugar levels. The approach is noteworthy because it is packaged as a series of synergistic research projects within broad pathways.
- The Biohub has three pillars:
- Engineering the transplant site: Identifying a location within the body to implant new cells.
- Inducing total reversal of autoimmunity: Modulating, or retraining, the immune system to accept the new cells without the need of anti-rejection drugs and, ultimately, halting the body’s attack on its own insulin-producing cells that caused the onset of the disease.
- Getting enough insulin-producing cells to cure and treat all patients: Researching sources for an unlimited supply of insulin-producing cells for transplant.
Human Trials Research
UM is currently overseeing eight clinical trials and is participating in an additional nineteen. More specific information about current and soon-to-be-launched BioHub trials is available on the DRIF website (Click here to view).
Recently, UM participated in the now-completed phase-III trial of transplantation of human islets in T1D complicated by severe hypoglycemia. Although the study’s focus was controlling hypoglycemic episodes, the transplantations resulted in insulin independence as well. One year after the first transplant, insulin independence was achieved by 52.1% of the 48 participants. After two years, 42% of participants remained insulin independent.
Ricordi states, “We have clearly shown that islet transplantation can work for the long-term reversal of diabetes, but requires immunosuppression that severely limits the applicability to the most severe cases of T1D. We are working on parallel tracks to solve this key barrier, and there are several approaches that appear very promising.”
According to Ricordi, the DRI also plans to start one additional immunomodulation studies within the year, including one that combines different strategies which aim to restore regulatory t cells and reduce inflammation.
Currently, UM is an active site for one PC project:
Caladrius T-Rex Study: An infusion therapy, Caladrius draws blood from the patient, separates Treg cells, and uses those cells to grow additional cells. The cells are then re-infused into the patient with the goal of balancing the immune system.