Islet Update: Progress in Each Protocol Thomas R. Hefty, M.D.

“We are all hopeful that 80 years after the isolation of insulin dramatically changed the outlook for patients with type I diabetes, we are now in the early stages of another quantum leap forward,” says Thomas R. Hefty, M.D.

A local consortium is in the forefront of that leap and as medical director of its islet cell processing laboratory, Dr. Hefty is understandably optimistic about the group’s progress. An update explains.

• The kidney-islet protocol has received investigational new drug approval from the FDA, and Dr. Christopher Marsh of the University of Washington (UW) has submitted application to the Institutional Review Board; the first transplant will follow at UW will follow impending approval.
• Progress on the Edmonton protocol includes: both lab site inspections passed, COBE cell processor modified, and qualification begun to meet Immune Tolerance Network (ITN) criteria. Once completed, islet-only transplants will occur first at Virginia Mason Medical Center (VMMC), where Dr. Hefty is transplant program surgical director.

As progress continues, good communication among consortium participants – UW, VMMC, Northwest Tissue Services, Swedish Medical Center, Pacific Northwest Research Institute and the Fred Hutchinson Cancer Research Center — becomes critical.

Because both of these protocols are considered experimental, only patients with severe, poorly-controlled type I diabetes will be eligible for islet transplants. The recipients will be selected from the organ transplant waiting list or an ITN-provided list of research procedure volunteers.