Miami, FL (June 2005) — Dedicated to making islet transplantation a clinical reality for those with diabetes, the DRI recently hosted a two-day workshop focusing on the new methods used to test the quality of islet cells prior to infusion into patients.
Attended by 24 researchers from 12 institutions around the world, The Islet Potency Workshop was a forum for investigators to discuss new technologies and develop standardized ways to assess islet viability and safety that can be carried out at all islet centers.
These agreed-upon standards will be necessary for obtaining Food and Drug Administration (FDA) approval of islet transplantation as it continues to move forward as an accepted treatment for type 1 diabetes.
“It was a great opportunity to meet with fellow scientists and look at standard assessment procedures, as well as novel approaches being developed at different institutions. We were able to determine which methods require enhancement to ensure the best preparations for our recipients,” said Dr. Luca Inverardi, director of Immunobiology of Islet Transplantation at the DRI and one of the organizers of the workshop, which was sponsored by the National Institutes of Health (NIH) and Clinical Islet Transplant Consortium.
Throughout the two days of hands-on presentations, scientists studied various methodologies currently in use at different centers and together, judged their effectiveness in determining if an islet cell preparation meets the quality standards necessary for clinical application.
A basic test performed pre-transplant evaluates how islets respond to a glucose challenge, which measures if a sufficient amount of insulin is produced on demand. The intricacies of this method often vary from center to center, however, making it difficult to compare results. Such variables as the type of culture media, the sample size, incubation temperature, and even the kits used to measure the insulin response often differ from one institution to the next. The group adopted standards for many of these variables, and agreed to conduct studies to determine others.
One of the more advanced technologies examined by the participants was Laser Scanning Cytometry (LSC), which determines the viability of the beta cells within an islet. Dr. Hirohito Ichii, who works in the DRI’s Human Cell Processing laboratory, demonstrated how this revolutionary technique identifies beta cell-specific apoptosis (pending cell death) at the most fundamental cell level.
The data generated by LSC is far more useful than that from prior methods in determining the quality and health of an islet cell preparation. However, the high cost and complexity of the procedure may prohibit some centers from using the new technology.
The safety of the islet preparation remains a critical factor that is routinely tested throughout the isolation procedure, as well as prior to islet transplantation. Several commercial assays are available today, and the centers will continue to conduct studies to determine which agents are the most reliable and effective.
‘Very Important Workshop’
“This was a very important workshop for the groups involved in clinical islet programs. As the field of islet isolation and transplantation moves forward, this workshop will be one of the key steps in defining islet parameters to support ongoing clinical islet transplant trials,” said Dr. Jonathan Lakey, director of the Clinical Islet Laboratory at the University of Alberta in Edmonton, Canada.
“Many of the assays described and taught by Dr. Ricordi and his team at the DRI are new, cutting-edge assays that will increase the understanding and knowledge of islet quantification and viability that are so desperately needed in the field.”