More Funding, Progress for Islet Program

Last quarter’s 5-year $1.5 million grant from the National Institutes of Health (NIH) made the islet cell processing laboratory at Northwest Tissue Services one of 10 national Islet Cell Resource centers (ICRs).

The islet core lab team (from left): Sabrina Qualley,
JoAnna Reems, Ph.D., Erik Olson, Lynn Sundberg,
Shilpa Goel, Shinichi Matsumoto, M.D., Ph.D.,
and Sharon Kaplan.

“The primary goal of the new grant is to provide islets for clinical transplantation,” said Jo Anna Reems, Ph.D., scientific director of the lab. “The secondary goals are to further develop our processing capabilities as well as to reimburse for organs to help subsidize our original JDRFI (Juvenile Diabetes Research Foundation International) grant to establish the lab for processing islets for kidney-islet transplantation.

“Specifically,” she explains, “funds will go towards optimizing our methods to recover, isolate, purify, store and ship the islets we use in the islet-only and kidney islet protocols, as well as to define potency assays that might allow us to predict the effectiveness of the islets once they’re transplanted into type I diabetes patients.

“This NIH grant provides great resources for our islet program.”

Recap, status
The Tissue Services islet program operates under the JDRFI umbrella grant given in 1999 to the local consortium known as HITS (Human Islet Transplantation in Seattle). Headed by Paul Robertson, M.D., director of the Pacific Northwest Research Institute, the consortium also includes the University of Washington, Virginia Mason Research Center, Swedish Medical Center and the Fred Hutchinson Cancer Center, as well as the Tissue Services. The goal is to transplant islets into seriously ill type I diabetics who are also receiving kidney transplants.

“We have our IND,” Dr. Reems says of the required investigational new drug exemption from the FDA. “Everything’s in place except for institutional review board approval at the University of Washington and we expect that any day now. As soon as that occurs, we have the green light to go to transplant, first at the University and later at Swedish Hospital.”

The Immune Tolerance Network (ITN) study is likewise nearing transplant stage. ITN’s goal is to confirm the results of the islet-only transplant success two years ago at the University of Alberta in Edmonton.

Like the other nine ITN sites, the Tissue Services had to meet stringent qualifiers and go through multiple NIH inspections, which occurred in November. Inspectors looked at records, SOPs and facilities. “There were some concerns with our facility that we’re addressing,” notes Dr. Reems.

“Physical changes will be made soon. So, almost everything’s in place for us to go to transplant.”

In the next 12 –15 months, four transplants will be performed at Virginia Mason Medical Center, where Thomas R. Hefty, M.D., is transplant program surgical director. Dr. Hefty is also medical director of the Tissue Services’s islet cell processing laboratory.

Next
The first ICR meeting took place at the end of November 2001 and the next will occur in February. At that gathering, the Tissue Services will submit an application to the group’s steering committee requesting permission to use restricted ICR grant funds for clinical grade pancreata for simultaneous kidney-islet transplants.

“At that point, all preparation will be made, conditions met,” says Dr. Reems. “We’ll just be waiting for the organs.”