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Severe diabetic problems end when patients receive transplanted cells, study shows
ATLANTA (CNN) -- Transplanting insulin-producing cells into severely ill diabetic patients has been successful in stopping blackouts and ending the need for injections of insulin, a team of researchers reported Tuesday.
Their findings were published in the New England Journal of Medicine, which released the study more than a month early because of its "potential therapeutic implications."
The researchers conducted their study on eight patients ranging in age from 29 to 54 who had severe cases of Type 1 diabetes, often called juvenile-onset diabetes. Each had a history of out-of-control metabolism and comas from very low blood sugar, the researchers said, and each had had diabetes for many years. They were being treated with insulin injections.
After the cell transplants, however, all the patients showed "sustained insulin independence," meaning they no longer required insulin injections.
All have remained insulin independent for at least a year since the transplants, which occurred during a 10-month period beginning in March 1999, the researchers said. And, oral glucose-tolerance tests showed that none of the patients met the criteria for diabetes currently used by the American Diabetes Association.
The study in NEJM reports the findings for only seven patients, the researchers said, because at the time the work was reviewed for publication, the eighth patient had not been insulin-free for the same period of time.
To conduct their study, the researchers refined a technique that has been tried in the past. They harvested islet cells, which produce insulin, from donor pancreases and injected them via a catheter into the livers of the seven patients.
They also gave the study subjects certain types of anti-rejection drugs, glucocorticoid-free immunosuppressants, to prevent rejection of the transplanted cells.
Previous studies have combined islet injection with anti-rejection therapy, with a success rate of 8 percent to 10 percent. The combination of a new harvesting procedure for the islet cells and the different class of immunosuppressant drugs is what made this study so successful, they said.
Although complications in the patients studied were minor, there are some drawbacks to the procedure. The possibility of long-term side effects isn't known, and the researchers have not yet been able to determine if there are other diabetic complications. Moreover, the donor cells can be difficult to obtain, since each patient requires cells from at least two pancreases.
Lead investigator Dr. James Shapiro of the University of Alberta in Canada said the procedure would be limited to people with severe Type 1 diabetes who cannot control blood-sugar levels -- to the point of "having devastating complications such as hypoglycemia unawareness which can cause blackouts and coma."
Dr. Norma Kenyon of the Diabetes Research Institute at the University of Miami said the Alberta procedure "is clearly a significant advancement in islet transplantation. This is the first time it has shown 100 percent success in humans."
CNN Correspondent Holly Firfer contributed to this report.
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American Diabetes Association
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