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WASHINGTON U. RESEARCHERS, CYTOTHERAPEUTICS REPORT DIABETES RESEARCH ADVANCE IN SCIENCE; ISLET CELL IMPLANTS UNDER SKIN CONTROL GLUCOSE LEVEL

WASHINGTON U. RESEARCHERS, CYTOTHERAPEUTICS REPORT DIABETES RESEARCH ADVANCE IN SCIENCE; ISLET CELL IMPLANTS UNDER SKIN CONTROL GLUCOSE LEVEL
 PROVIDENCE, R.I., Dec. 19 /PRNewswire/ -- Researchers at Washington University in St. Louis and CytoTherapeutics Inc. (formerly Cellular Transplants, Inc.) have successfully controlled blood sugar (glucose) levels for extended periods in mice with a small islet cell-containing membrane implanted under the skin. The research, reported in the December 20 issue of the journal Science, is the first to demonstrate the potential for treating insulin dependent diabetes by implanting encapsulated, insulin-producing cells beneath the skin.
 "This research is an important step toward the development of islet cell implants to treat insulin dependent diabetes," said Paul E. Lacy, M.D., Ph.D., Robert L. Kroc Professor of Pathology at Washington University and the lead author on the paper. "It is particularly encouraging that the implant functioned as well under the skin as when placed in the abdomen. A device placed under the skin is the most practical method for implanting islet cells because it can be inserted and retrieved easily. The findings also fulfill several other prerequisites for an islet encapsulation device for possible use in human diabetics, including biocompatibility and prevention of rejection."
 The studies in Science build on the pioneering islet transplantation research by Lacy and David Scharp, M.D., Professor of Surgery at Washington University School of Medicine. In 1990, Lacy and Scharp were the first to demonstrate in humans that transplanted islets can eliminate the need for insulin injections in diabetic patients. These initial studies involved unencapsulated human islets. This experimental protocol required that patients be on immunosuppressive drugs to prevent rejection of the islets.
 "Encapsulation devices that isolate the implanted cells from the immune system, allowing them to survive and function without the need for immunosuppressive drugs provide promise as a therapeutic approach to diabetes," said Dr. Lacy.
 Islet cells, also known as Islets of Langerhans, are located in the pancreas. These groups of cells are responsible for producing and secreting insulin, a hormone critical for the breakdown of glucose. In insulin dependent diabetes, also known as diabetes mellitus, insulin producing islet cells are destroyed, and as a result patients currently must receive daily insulin injections to control blood glucose levels. The onset of diabetes mellitus typically occurs in childhood or early adolescence. According to the American Diabetes Association, diabetes mellitus affects over one million individuals in the United States.
 In the studies reported in Science, the researchers suspended in a gel and encapsulated rat islets into hollow, semi-permeable plastic fibers and implanted the devices either under the skin (subcutaneously) or inside the abdomen (intraperitoneally) of diabetic mice. The mice implanted with the encapsulated rat islets did not receive immunosuppressive drugs. The fibers, produced at CytoTherapeutics, were less than one inch in length. Seven or eight of these fibers containing a total of either 500 or 1,000 islets were transplanted into the mice. The fibers were engineered so that the outer surface was extremely smooth.
 For 60 days, the implant maintained normal glucose levels in over 80 percent of the recipients at either the subcutaneous or intraperitoneal sites with either 500 or 1,000 islets. When the implants were removed at the end of the 60-day period, the diabetic condition returned.
 "The ability of the subcutaneous implant to function effectively in mice with as few as 500 rat islets provides encouraging support that a device of an acceptable size can be designed for human use," said Orion Hegre, Ph.D., CytoTherapeutics' director of Endocrine Science and a co-author on the study. "An implant suitable for human use is expected to require about 500,000 islets."
 The scientists said that the next research step in their collaboration is to design and test a device for use in larger animals. The researchers hope to have a device ready for initial human testing in several years.
 In addition to Drs. Lacy and Hegre, the authors on the paper are Andriani Gerasimidi-Vazeou, M.D., of Washington University and Frank T. Gentile, Ph.D., and Keith E. Dionne, Ph.D., both of CytoTherapeutics.
 CytoTherapeutics Inc. (formerly Cellular Transplants, Inc.) is developing membrane products to treat a variety of chronic and disabling diseases through the implantation of encapsulated living cells and tissues. The company is based in Providence, R.I.
 -0- 12/19/19
 /CONTACT: Erika Karplus of CytoTherapeutics, Inc., 401-272-3310; or Joni Westerhouse of Washington University, 314-362-8258/ CO: CytoTherapeutics Inc. ST: Rhode Island; Missouri IN: MTC SU:


DD-PB -- NE023 -- 4158 12/19/91 18:06 EST
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Date:Dec 19, 1991
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