Exciting progress has been made recently in the quest for a diabetes cure and the Northwest Tissue Services is among a select number of research facilities involved in the latest developments.

In 1999, the Tissue Services was among six Seattle institutions awarded a three-year grant by the Juvenile Diabetes Foundation International (JDF) and just this past summer, President Clinton announced 10 clinical centers worldwide chosen to participate in a major study overseen by the Immune Tolerance Network (ITN). Seattle is one of the cities named, and the Tissue Services, is one of the participating institutions.

The islet research team (from left): Ted Rigley, Sabrina Qualley, Ian Sweet, Ph.D., Jessica Chawla, Levi Anderson, Shinichi Matsumoto, M.D., Ph.D., Shilpa Goel, Jo Anna Reems, Ph.D. and Brian Stevens, M.D., Ph.D., medical director.

These extraordinary research efforts all focus on islet transplantation.

Found in the pancreas, islets are clusters of insulin-producing cells called beta cells, plus a much smaller number of cells that produce enzymes to aid digestion. Healthy beta cells release insulin to help maintain normal glucose levels in the body, but in some people these insulin-producing cells are destroyed by the body’s own immune system. The result is type 1 diabetes.

For those with the disease, the transplantation of functional islets holds the potential to end lifelong dependence on insulin injections.

Much of the research toward the eventual realization of that potential is being done locally. The JDF and ITN studies are carried out, in part, through collaborating organizations in the Seattle area. Under the direction of Pacific Northwest Research Institute Director Paul Robertson, M.D., the consortium involves researchers and clinicians from the University of Washington, Virginia Mason Research Center, Swedish Medical Center, Fred Hutchinson Cancer Research Center and the Northwest Tissue Services. This collegial arrangement is the Human Islet Transplantation in Seattle project, also known as HITS.

New direction
The program focus was recently changed due to a report in the New England Journal of Medicine* detailing the islet cell transplant program in Edmonton, Alberta, Canada.

The authors reported that they had cured seven of seven type 1 diabetics with islet-only transplants, and the news rocked the medical and scientific world.

Subsequently, the ITN and the National Institutes of Health announced plans to fund an international program with the specific goal of duplicating Edmonton’s success. And the Northwest Tissue Services was selected as one of the 10 centers to reproduce those startling results. Consequently, “Our original plan to process islets for kidney-islet transplantation under the HITS program is now on hold. Once we have succeeded with the Edmonton protocol to transplant islets only we will return to our plan to transplant kidney-islets under the HITS program,” says Jo Anna Reems, Ph.D., islet program scientific director.

The factors that likely play a role in that success are the high quality of the islets, their immediate transplant, and a modified immunosuppressive regimen for the recipients. Patients receive no steroids and less cyclosporin than do organ transplant recipients, since both drugs concentrate in the liver – where the islets are delivered – and they are known to adversely affect islet function and survival.

Recently, the Food and Drug Administration (FDA) announced that an islet transplant protocol first must be approved as an investigational new drug (IND). The ITN has already sought approval for the Edmonton protocol, so all 10 centers will process, transplant and track the outcomes under the umbrella IND.

“Of course, islet donors must be evaluated and found suitable as tissue donors in accordance with FDA regulations,” notes Dr. Reems. “Our expertise in this and other areas of FDA regulation positions the Tissue Services’s program for success.”