With clinical trials complete, private funds are needed to gain FDA approval for human islet transplants
Pastor Constance “Connie” Olson worked 70-hour weeks, tending to the needs—spiritual and otherwise—of her congregation. She was also a type 1 diabetic, suffering from hypoglycemic unawareness. This complication meant that she didn’t experience early warning signs of dangerously low blood sugar—such as sweating, dizziness, and extreme hunger—causing her to unexpectedly have seizures and lose consciousness.
“I was very rigid in my care,” Olson says. “I tested my blood sugar 12 times a day. I never drove without testing. And I was afraid to leave the house without my glucose tablets or monitor. I loved my work, and it was really hard for me to admit that I wasn’t feeling well.”
Olson applied to and was eventually accepted into the University of Minnesota’s human-to-human islet cell transplantation clinical trial—her best hope of a cure. After undergoing two islet transplants, she is now free from the daily burden of diabetes.
The clinical trial that Olson participated in is now complete and boasting impressive results. And the University is positioned to become one of the first centers in the country to offer human islet transplantation as a routine medical procedure for qualified adults. The final step needed to bring these transplants to more patients is the estimated $5 million funding required to obtain a biologic license from the U.S. Food and Drug Administration (FDA) to procure islets from donor pancreases for transplantation.
U of M: A leader in human islet transplantation
The transplantation of islets from a donor pancreas into a diabetic patient has been studied since the 1970s. In fact, the first transplant of its kind to treat type 1 diabetes occurred at the University in 1974. Numerous studies and clinical trials have followed, with tremendous progress in recent years.
In 2004, the University was selected as one of three principal sites to conduct phase III clinical trials in human islet transplants—a $100 million, multicenter trial supported by the National Institutes of Health. The clinical trial was a success for patients like Olson and many others, giving them lives free from diabetes.
“No other center has enrolled more patients than the U of M,” says Bernhard Hering, M.D., scientific director of the University’s Schulze Diabetes Institute. “The U of M has been a major contributor to this study at several levels.”
The best results
Today, the U’s clinical trials are delivering the world’s best results: all transplant recipients were protected from hypoglycemia immediately after the transplant, 80 percent remained protected from severe hypoglycemia for five years post transplant, 90 percent have become insulin independent, and more than 50 percent have maintained insulin independence for five years post-transplant.
“It is fair to say that both the efficacy and safety results are very favorable and clearly document the feasibility of the human islet transplants in helping and treating people with type 1 diabetes complicated by hypoglycemic unawareness,” Hering says.
He emphasizes how miserable life can be for those with hypoglycemic unawareness, recalling stories of patients who have lost jobs, homes, and marriages. But after receiving the islet transplant, patients seem to get a second chance at a normal life.
“With islet transplantation, people now, for the very first time, can enjoy a life no longer restricted by constant fears and worries. We consider this a privilege, being able to participate in this life-changing research,” Hering says.
Funding still needed
With decades of research complete, the University has one more step: securing a biologic license from the FDA to procure islets from donor pancreases for transplantation, a process that will require about $5 million.
A lead gift of $50,000 from Wally and Cecy Faster in January of this year will help the University of its way to raising the funds needed to become the first U.S. clinic to transplant human islets as an approved medical procedure.
Once licensed, the University will offer patients greater access to islet transplantation and will use this treatment as the platform for continuing to develop the next-generation of transplantation cures, including the use of pig and stem cell islets, with minimal or no antirejection drugs.
Today Olson is busy spreading the gospel of islet transplantation, speaking to groups about the transformational procedure. “It’s one way for me to contribute,” she says, “to say thank you and to help make future transplants possible, especially for children.”
Help us reach this goal
Contact Jean Gorell at 612-625-0497 or email@example.com.