The aim of this study is to employ islet preparations, derived from the pancreases of brain-dead donors, to treat Type 1 diabetes patients. All recipients required islets from at least two donor pancreases. Islet transplantation was conducted in conjunction with a glucocorticoid-free immunosuppressive regimen.
In the original study, all 7 recipients quickly attained sustained insulin independence after transplantation, which persisted throughout the entire 12 month follow-up period. However, in an international multi-center study, only 16 of 36 recipients achieved insulin independence with adequate glycemic control one year after the final transplantation. In a 5 year study, conducted in 65 patients who underwent islet transplantation in Edmonton, Canada, the researchers reported that the majority of patients had to resume insulin therapy; only 7.5% of the patients gained insulin independence after 5 years.
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Pancreases were removed from brain-dead donors, and islets were isolated via perfusion of the ducts with an ice-cold enzyme solution. Islets were digested, separated, purified and analyzed and transplanted immediately thereafter.