Diabetes Research Program

The Diabetes Research Program at The Rogosin Institute began in 1987. Its development was stimulated by the fact that by far the largest cause of end-stage kidney disease today is diabetes. More effective treatment of diabetes would mean less kidney disease, as well as fewer and less severe other complications of this common disease, including brain and nerve damage, blindness, heart and blood vessel disease, and susceptibility to infections and loss of toes and even limbs.

Islet Macrobead Research

It has now been established that replacement of the cells that produce insulin in the body (beta cells in the islets of the pancreas) can reverse insulin-dependent diabetes, freeing patients from the need to inject insulin. However, with the supply of human islets severely limited and with Rogosin's initial work and that of others indicating that islets from pigs could be successfully used to treat human diabetes, in partnership with Bob Evans Farms, Inc. and MetMedical, Inc., Rogosin created the Diabetes Research Center in Xenia, Ohio. This Center, which is located at a pig (porcine) processing facility, has enabled Rogosin Institute to obtain the best quality porcine islets for our research. This capability is unique to Rogosin's program.

Our diabetes research also involves a unique encapsulation of the islets in macrobeads that are made with a seaweed product called agarose. These macrobeads provide a suitable environment for the long-term maintenance of the islets in the laboratory and also after implantation in animals or humans, since they provide both a structure and protection from the immune system of the recipient.

More than a decade of diabetes research at Rogosin has enabled us to optimize the quality and number of isolated porcine islets and to ensure their safety for humans. Biological safety is a major concern,and special programs have been developed to ensure the health of the pigs/hogs that serve as donors and the testing of the isolated islets prior to their implantation in humans. In addition, the ability to maintain islets in the special macrobeads for at least two years means that their microbiological safety can be established far better than other preparations, including those that involve microencapsulation. Extensive animal testing has confirmed both the safety and effectiveness of the macrobeads. As a result, today, the Rogosin research macrobead program is the foremost of its kind in the world.

FDA Approval

Rogosin has been working with the Food and Drug Administration for over five years to gain approval for the first (Phase 1) human use of this treatment. We expect to receive this approval in the Spring of 2008, which represents a major achievement for The Institute and for diabetic patients. The first patients to receive the macrobeads will be those with severe, unstable diabetes and the added problem of the inability to detect when their blood sugars are dangerously low (hypoglycemic unawareness). The applicability of the islet macrobeads to patients with less severe and ultimately non-insulin-dependent diabetes will follow. Another advantage of Rogosin's islet macrobeads is that patients treated with them will not need immunosuppressive drugs. As a result, people of all ages with diabetes will be able to participate in the planned trials.

For further information on diabetes research at The Rogosin Institute contact:
Barry H. Smith MD, PhD
212-746-1552