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Islet transplantation shows promise in type 1 diabetes
Among patients with type 1 diabetes who underwent islet transplantation within the GRAGIL Network, most attained long-term islet graft survival and substantial improvements in glycemic control, according to recent findings.
Sandrine Lablanche, MD, of Grenoble University Hospital in France, and colleagues evaluated 44 patients enrolled in the GRAGIL-1c and GRAGIL-2 islet transplantation trials to determine metabolic control, graft function and safety outcomes after 5 years.
The two trials were conducted between 2003 and 2010 by the GRAGIL consortium, a Swiss-French network consisting of various transplant centers facilitating pancreas procurement, recruitment of recipients, transplant procedures and follow-up. The GRAGIL-1c focused on islet after kidney transplantation and GRAGIL-2 pertained to islet transplantation alone.
Of the 44 patients analyzed, 54.5% underwent islet transplantation alone and 45.5% underwent islet after kidney transplantation. Patients were administered a total islet mass of 9,715.75 ± 3,444.4 islet equivalents (IEQ)/kg body weight. Thirty-four patients completed the 5-year follow-up, with 10 patients completing 4-year follow-up.
The researchers found that at 1 year after islet transplantation, 83% of the islet transplantation alone group and 80% of the islet after kidney transplantation group achieved an HbA1c level of less than 7% and had no severe hypoglycemia. At 4 years, 67% of the islet transplantation alone group and 70% of the islet after kidney transplantation group met the composite target for HbA1c control and no severe hypoglycemia. At 5 years, 58% of the islet transplantation alone group and 60% of the islet after kidney transplantation group maintained an HbA1c level of less than 7% and were free from severe hypoglycemia.
Seventy-five percent of participants achieved insulin independence at some point during follow-up, with a median insulin independence duration of 19.25 months. At least one adverse event was recorded for 66% of participants, with 33% of 55 adverse events potentially related to immunosuppression. Eighty-four complications regarding the islet infusion were seen in 10 patients.
“In conclusion, islet transplantation within the multicenter GRAGIL Network provided important and lasting clinical benefits to patients with type 1 diabetes, permitting improvement of glucose variability and preventing the occurrence of severe hypoglycemia,” the researchers wrote. “The benefits of islet transplantation are somewhat tarnished by decreasing long-term insulin independence and immunosuppression-related adverse events. Safer immunosuppression and further strategies to promote long-term islet graft survival or other sources of islets remain an absolute prerequisite for improving islet transplantation outcomes and increasing the availability of the procedure.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.