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[IP] Islet Cell Transplantation -- NEJM pre-publication release


The New England Journal of Medicine has pre-released the paper regarding
islet cell transplantation.  Here's the abstract.  I have not had the chance
to read the full article, so I offer no comment.

Jim Handsfield
Centers for Disease Control and Prevention
mailto:email @ redacted OR
mailto:email @ redacted

The opinions expressed are my own and do not necessarily represent those of
the Centers for Disease Control and Prevention, the United States Public
Health Service or any other agency of the United States government.

*** Begin Forwarded Abstract ***

Notice: Because of its potential therapeutic implications, this article is
being released before its publication date, in accordance with the Journal's
policy (Angell M and Kassirer JP. The Ingelfinger Rule revisited.
<http://www.nejm.org/general/text/editorial.htm> N Engl J Med
1991;325:1371-2). The final version of the report will be published on July
27. (Notice posted June 6, 2000.)

Islet Transplantation in Seven Patients with Type 1 Diabetes Mellitus Using
a Glucocorticoid-free Immunosuppressive Regimen

A.M. James Shapiro, Jonathan R.T. Lakey, Edmond A. Ryan, Gregory S. Korbutt,
Ellen Toth, Garth L. Warnock, Norman M. Kneteman, Ray V. Rajotte 


Registry data on patients with type 1 diabetes mellitus who undergo
pancreatic islet transplantation indicate that only 8 percent are free of
the need for insulin therapy at one year. 

Seven consecutive patients with type 1 diabetes and a history of severe
hypoglycemia and metabolic instability underwent islet transplantation in
conjunction with a glucocorticoid-free immunosuppressive regimen consisting
of sirolimus, tacrolimus, and daclizumab. Islets were isolated by ductal
perfusion with cold, purified collagenase, digested and purified in
xenoprotein-free medium, and transplanted immediately by means of a
percutaneous transhepatic portal embolization. 

All seven patients quickly attained sustained insulin independence after
transplantation of a mean (±SD) islet mass of 11,547±1604 islet equivalents
per kilogram of body weight (median follow-up, 11.9 months; range, 4.4 to
14.9). All recipients required islets from two donor pancreases, and one
required a third transplant from two donors to achieve sustained insulin
independence. The mean glycosylated hemoglobin values were normal after
transplantation in all recipients. The mean amplitude of glycemic excursions
(a measure of fluctuations in blood glucose concentrations) was
significantly decreased after the attainment of insulin independence (from
198±32 mg per deciliter [11.1±1.8 mmol per liter] before transplantation to
119±37 mg per deciliter [6.7±2.1 mmol per liter] after the first
transplantation and 51±30 mg per deciliter [2.8±1.7 mmol per liter] after
the attainment of insulin independence; P<0.001). There were no further
episodes of hypoglycemic coma. Complications were minor, and there were no
significant increases in lipid concentrations during follow-up. 

Our observations in patients with type 1 diabetes indicate that islet
transplantation can result in insulin independence with excellent metabolic
control when glucocorticoid-free immunosuppression is combined with the
infusion of an adequate islet mass. 

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