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Transplants Using Cultured Islets From Cadaver Donors Successful in Small Series

WASHINGTON (Reuters Health) Apr 29 -Ten of eleven patients who underwent

transplantation with islet cells cultured from cadaveric pancreases achieved

insulin independence, according to results presented Monday at the American

Transplant Congress, Transplant 2002.

Two of the ten patients who achieved insulin independence were restarted on

insulin, one at 208 days after transplantation and one at 356 days, but both are

maintained at low insulin levels (3 units and 6 units respectively).

Those favorable results from the University of Miami and the Diabetes Research

Institute, contrast with other results reported here of a study from the

National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK), in which

only three of six patients transplanted with fresh islet cells achieved insulin

independence.

Moreover, NIDDK investigator Dr. a I Rother said the side effects of

treatment included " a paralyzing fatigue. " Dr. Rother said that, while NIDDK is

still interested in islet transplantation, when transplantation is performed in

otherwise healthy diabetic patients " it can turn patients with essentially no

complaints into patients with debilitating disease. "

But Dr. Rother's comments were greeted with little enthusiasm from an audience

that applauded the positive results presented by the Miami researchers. During

the discussion period, one physician suggested that Dr. Rother should " try to

tell this story in a more positive way. "

Dr. Rodolfo and colleagues from the University of Miami, in presenting

their positive findings, suggested that by culturing islet cells from cadaveric

organs " we may have overcome some of the problems associated with the Edmonton

protocol. "

He was referring to researchers from Edmonton who reported in 2000 that diabetic

patients transplanted with fresh islet cells had achieved good glycemic control

and were insulin free. But the use of fresh islet cells required prospective

recipients to live within 2 hours of the hospital.

Dr. said the islet cells are cultured for a mean of 31 hours (range 8

to 72 hours) in an antioxidant-rich medium, initially at 37 C and then

maintained at 22 C.

The eleven patients, six males, five females, were ABO- matched to donors. The

average age of patients was 39 and the mean duration of diabetes was 26 years.

Islets were transplanted via ultrasound-guided percutaneous transhepatic

intraportal infusion. Immunosuppression consisted of daclizumab induction and

sirolimus/tacrolimus maintenance. All patients received 2 islet infusions.

Insulin requirements decreased from a mean of 0.53 0.04 U/kg/day (n=7) to 0.2

0.07 U/kg/day after first transplant. Ten patients achieved immediate insulin

independence after second transplant.

Dr. said side effects " are compatible with immunosuppressive therapy

and include mouth ulcers. "

On the other hand, Dr. Rother said the six patients treated in the NIDDK

protocol " had significant immunosuppressive side effects. Including mouth

ulcers, neutropenia, anemia, hyperlipidemia, peripheral edema, and diarrhea.

Moreover, two major complications were associated with the procedure: partial

portal vein thrombosis in the second patient transplanted and intraabdominal

hemorrhage requiring packed red cell transfusion in the fifth patient.

However, Dr. Rother said that the three patients who remain insulin dependent

require 50% or less of their pretransplant insulin dose. " Significant

hypoglycemia appears to have been eliminated in all patients, " she said.

Dr. Rother concluded that better immunosuppressive strategies are needed before

islet transplantation can be widely used.

Mark E. Armstrong

NW Rep, PAI

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