The Xenia, Ohio Division of The Rogosin Institute
The Xenia division was created in 1994 and is dedicated to research in cancer and diabetes. This includes an Islet Isolation Laboratory in the Bob Evans Farms Inc. facility and Rogosin’s adjacent building housing the Diabetes and Cancer Research Laboratories. Larry Gazda, PhD, Director of the Xenia Division, is responsible for both the diabetes and cancer programs with executive direction under Barry Smith, MD, PhD, President of The Rogosin Institute.
The Diabetes Research Program
The diabetes research program developed because the largest cause of end-stage kidney disease is diabetes. The aim of the program is to provide a more effective treatment for diabetes which could result in less kidney disease as well as other diabetes-related complications such as heart and blood vessel disease, nerve damage and vision impairment. Rogosin’s diabetes research in Xenia is centered on replacing the insulin producing pancreatic islet cells, that have been lost in type 1 diabetes patients, with fully functional islets isolated from pigs. Rogosin partnered with Bob Evans Farms where pig islet cells are isolated and placed in small beads (about the size of a pea) made from agarose, a seaweed product. These beads are termed porcine islet macrobeads and when implanted in animals with diabetes, the encapsulated islets produce insulin and normalize glucose metabolism in the absence of any replacement insulin injections. In the laboratory, the islets survive for more than a year after encapsulation in macrobeads, providing plenty of time to ensure a high level of function and, critically, safety prior to implantation. The islet macrobeads have recently been tested in diabetic monkeys and have shown long-term function and safety (>3 years). Importantly, the diabetic animals treated to date have not required the addition of medications, for example to suppress the immune system, and this is thought to add considerable safety to islet macrobead therapy.
It is projected that the first human patients to receive porcine islet macrobeads will be those with severe, unstable diabetes. The macrobeads will be placed into the abdominal cavity during an outpatient minimally invasive laparoscopic procedure where they will distribute and remain free-floating throughout the abdomen. In this way, the macrobeads sense the glucose level of the recipient and release insulin and other therapeutic proteins. The Institute is currently working with the Food and Drug Administration with the goal to begin treating people with type 1 diabetes as part of a clinical research study.
The Cancer Research Program
The cancer program was formed to develop a treatment option for the large population of patients with end stage kidney disease as a result of their cancer. A cancer macrobead, similar to the islet macrobead, is used here but in this case tumor cells are encapsulated within the macrobead. The cells come from a frozen stock of well-characterized mouse tumor cells and form tumor colonies when placed inside the macrobead. The tumor colonies grow to a maximum size but cannot escape the confines of the macrobead. It is at this point of restricted growth that the encapsulated colonies produce proteins that not only inhibit their own growth, but also diffuse out of the macrobeads and retain the ability to inhibit the growth of tumors in patients. At least ten of the secreted proteins so far identified have known anti-cancer effects. A major research focus in the Xenia laboratories is to continually discover the molecular details of how these proteins work to inhibit tumor growth. Interestingly, the macrobeads have been shown to affect different types of tumors from several animal species demonstrating that many cancers respond to these proteins, which appear to be well conserved throughout evolution.
The cancer program has transitioned from pre-clinical research studies treating animals with various tumors to the first human trials. Multiple types of cancers were treated as part of a Phase 1 clinical safety trial. Phase 2 efficacy trials have been initiated focusing on colorectal cancer, pancreatic cancer, and prostate cancer. The colorectal cancer trial is multicenter and has prompted the development of a semi-automated production process for the manufacturing of the macrobeads that are used for this clinical research study. The Institute continues to work with the Food and Drug Administration in ongoing efforts to make this therapy available to as many people as possible.
Additional clinical trial and patient information can be viewed on the Macrobead webpage: