U of M scientists work to improve treatments worldwide
Diabetes has quickly become a global epidemic and the leading cause of cardiovascular disease, blindness, kidney failure, neuropathy, and amputations. The World Health Organization estimates that 220 million people have diabetes and that related deaths will double by 2030.
To combat this threat, scientists from the University’s Schulze Diabetes Institute (SDI) are leading the way in developing a cure for type 1 diabetes and expanding the availability of the most promising treatments. Discoveries in type 1 diabetes help advance knowledge about type 2 diabetes, which accounts for 90 percent of all diabetes cases worldwide.
“There are many people around the world who need diabetes therapies and don’t have access,” says Klearchos Papas, Ph.D., an adjunct faculty member in the University’s Department of Surgery. “Making them available to other people in need is critical. This positions the U.S. and the University to be a leader.”
International partnerships yield results
Collaborations—both with corporations and academic institutions—are key to combatting diabetes on a global scale, says SDI program director Brian Flanagan, Ph.D. “These groups can provide us with new and innovative technologies,” says Flanagan, referencing access to new drugs, scientific compounds, and medical devices. “That speeds up research.”
One of SDI’s many successful international collaborations is its partnership with Immerge Bio Therapeutics, based in Switzerland. With colleagues from the University and Immerge, SDI’s scientific director Bernhard Hering, M.D., reversed diabetes in monkeys using islet cells harvested from pig pancreases. The findings were published in Nature Medicine.
Building on its long record of success in Phase I and II clinical trials using human islets, the SDI is now conducting two Phase III clinical trials for human islet transplants at the University. These clinical trials are the last step before the human islets can be considered a treatment for approval by the U.S. Food and Drug Administration and subsequent reimbursement by insurance companies, including Medicare.
Philanthropy—including a $40 million pledge from the Richard M. Schulze Family Foundation in 2009—is essential to SDI’s work. “Donor support is crucial,” says Papas, adding that philanthropy helps provide crucial support to supplement large government funding.
Collaboration spurs improvements in global access
Papas is using industry collaborations to help countries gain access to the University’s pioneering protocols for diabetes treatment. “A lot of our work is focused on technologies and tools that will improve the availability and affordability of islet transplantation,” he says.
The islet cell transplant method Hering is testing in the clinical trial has allowed study participants—people with life-threatening side effects caused by diabetes—to live diabetes-free lives without constant insulin monitoring, but the short-term viability of donor pancreases makes the procedure unusable in many other countries.
Once a donor pancreas is procured, doctors have just eight hours to assess the organ’s viability ship it from the procurement hospital to the isolation facility and isolate and culture the islets before they can be transplanted into diabetic patients. After eight hours, the organ does not have sufficient oxygen and becomes unusable.
This small window of time limits the worldwide applicability of the treatment. Islet manufacturing facilities are costly to build and maintain, and so many countries cannot afford them. Centralized islet manufacturing facilities could make islet transplantation more affordable and widely available, but the time restriction limits the use of centralized facilities to neighboring countries only.
To expand this window, Papas partnered with Giner Inc., based in Newton, Mass., to adapt an oxygen-generation technology currently used on nuclear submarines to provide oxygen during preservation and extend the lifespan of a donated pancreas to 24 hours.
“Gas goes through the islets and removes red blood cells and helps to preserve the organ,” explains Papas, adding that this technology is also being tested for use with other donor organs, such as the kidney, liver, and heart.
Papas is using this preservation technology to establish a standardized islet transplantation regimen in Greece, in collaboration with the University of Athens and an islet isolation facility in Geneva, Switzerland. “It will be hands-on, helping scientists at the University of Athens with the techniques to transplants islets into patients,” he says.
The technology, says Papas, could help SDI’s treatment protocol become a global model for countries currently without islet transplantation programs and also help extend the organ viability for donated hearts, livers, and kidneys. “We could maintain the [organ] quality and treat people who would otherwise die.”
The initial collaboration with Giner was made possible with philanthropic support from the Carol Olson Memorial Diabetes Research Fund and the Schott Foundation. “They provided seed funding that enabled all of this,” says Papas, who emphasizes that the philanthropic dollars allowed him to gather enough data to attract substantially more funding from the National Institutes of Health.
Papas says he’s grateful for that support and has seen what a difference it can make. “Philanthropists are the people who make things happen,” he says.