At this moment, it is entirely possible to envision type 1 diabetes as a disease of the past.
Today, the Schulze Diabetes Institute stands on the very threshold of bringing the first minimally invasive treatment option to market as we complete the final phase of clinical trial for human islet transplantation.
This phase, which involves studying the effectiveness of various immunosuppressive drugs, is nearing completion in 2013. Soon, more patients will be able to receive this treatment and enjoy freedom from the devastating effects of diabetes.
But we’re not stopping there.
While this treatment is effective and changes lives, it's not perfect. Human islet cells rely on donor pancreases, which are in limited supply. Without immunosuppressive drugs, the recipient’s body will reject the transplanted cells.
There is great promise that these barriers can be eliminated or minimized for an even better cure.
Our researchers are aggressively pursuing ways to improve upon islet cell isolation and transplantation technology. They've made great progress in the use of pig-derived islets, and stem cells are proving to offer tremendous potential to conquer this disease.
Our commitment is unwavering. We're working on multiple approaches to solve the same problem. These synergies will help us find the best cure faster – and we will not stop working until we do.
New protocols using human islets from 2 to 4 donors per transplant recipient, plus changes to anti-rejection drugs, have greatly improved clinical trail outcomes. These improvements have moved the initial success rate for insulin dependence from 10% to nearly 90% post-transplant, with more than 50% remaining insulin independent after 5 years.
As human islet transplant moves towards the final phase of clinical trails, we will continue to find ways to increase patient access to islet transplantation. Some examples include:
- Developing a new enzyme combination, used to prepare islets for transplantation. We have obtained approval from the National Institutes on Health and the U.S. Food and Drug Administration to test this new blend in clinical trials. The goal here is to maximize the quality and quantity of the human islet supply.
- Assessing the potential of Treg cells in monkeys to prevent rejection of transplanted human islets without need for daily immunosuppression.
Melena Bellin, MD
Dr. Bellin’s research focus is islet transplantation (transplantation of the insulin-producing cells of the pancreas) for patients with type 1 diabetes mellitus and for patients who have their pancreas removed to treat severe chronic pancreatitis.
Islet isolation is the foundation of islet transplantation, and our scientists have literally redefined the process. Today, we are one of the few programs in the world capable of consistently producing high-quality islets -- propelling the University of Minnesota to its position as a world leader in islet transplantation.
The islet isolation and purification process consist of these basic steps:
- The donor pancreas is brought to a special laboratory at the University of Minnesota whose purpose is to make biological products.
- The pancreas is cut into small pieces and put in a special container with steel marbles. The container is shaken, and enzymes are added to break down the tissue so the islets are freed from the rest of the tissue.
- The islet tissue cells are removed, washed, counted and checked to be sure they are not damaged. On average, approximately 500,000 of the 1 million islets in a pancreas can be retrieved. This number of islets can usually maintain normal blood sugar levels. If the number or quality of islets is not satisfactory, the transplant must be canceled.
- If the number or quality of islets is satisfactory, the islets are cultured for two days before transplant.
The Schulze Diabetes Institute has developed a standardized method for objectively assessing the quantity and quality of islet products to ensure their suitability for transplant. We use digital imaging analysis to determine the quantity, purity, integrity, cellular identity, and viability of the islets. Our expertise in this area has led to universal acceptance of objective, standardized methods of assessing islet quantity and quality.
David E. Sutherland, MD, PhD
Dr. Sutherland performed the world's first living-donor partial pancreas transplant in 1979. Still one of the world's leading pancreas transplant surgeons, his specialties include pancreas and kidney transplant, pancreatic surgery and general surgery.
With genetics amazingly compatible to humans, pigs can provide an unlimited source of islets for transplantation. The team led by Bernhard Hering, M.D., scientific director of the Schulze Diabetes Institute, has successfully reversed diabetes in animal models using pig islet cells. Soon, the Institute will be in the position to submit an application to the FDA to move forward with pig-to-human clinical trials.
Looking ahead, our researchers will be pursuing two distinct technologies for advancing pig islet transplantation to cure diabetes:
- The first approach, already moving toward clinical trials, employs so-called “wild type” or regular pigs. The process is much like that of human islet transplantation. The islets from these pigs are harvested and processed and then transplanted into the patient’s liver. The patient is given standard immunosuppression therapy to prevent rejection of the transplanted islets. Dr. Hering’s research team is currently developing a cell therapy to offset immunosuppression issues related to xenotransplantation (transplantation from one species to another).
- The second approach uses “transgenic” animals – pigs that are genetically engineered to possess a special gene to reduce or eliminate the need for immunosuppression. The islets from these pigs will be transplanted into a specially created (bioengineered) site. The patient will receive a vaccination prior to transplant to further help reduce or prevent rejection of the islets. The goal here is twofold: to obtain a readily available supply of islets and eliminate the need for – and negative side effects of - immunosuppression drugs.
The Schulze Diabetes Institute has an established relationship with Spring Point Project, a nonprofit organization that raises medical-grade pigs to supply islets for transplantation at the Institute.
Bernhard J. Hering, MD
Dr. Hering is internationally renowned for his expertise in islet cell transplantation. His research focuses on finding innovative cell-based therapies to restore blood glucose control and insulin independence for people with type 1 diabetes.