French researchers report, that with good graft function, islet transplantation can achieve long-term metabolic control in patients with brittle Type 1 diabetes.
Senior investigator Dr. Francois Pattou stated that, “Replacement of insulin-producing cells, holds great promise for treating diabetes. We showed that when optimal graft function is achieved, islet transplantation can normalize blood glucose for up to 5 years in the majority of patients.”
Dr. Pattou of University Lille Nord de France and colleagues enrolled 14 patients (mean age 42 years) in a phase 2 study of islet cell transplantation. Patients received a median of 12,479 islet equivalents per kg in 2 or 3 infusions within 3 months.
By an average of 12 days after the last infusion, all patients were insulin independent. At 1 month after the last infusion, graft function was deemed optimal in 9 patients and suboptimal in the remaining 5.
At 1 year, 10 patients met the primary outcome: graft survival, as indicated by insulin independence with hemoglobin A1c of no more than 6.5%.
At follow-up ranging from 2 to 5 years after transplantation, 8 patients were still insulin independent with adequate metabolic control. All but 1 had optimal graft function early after transplantation.
A1c level, mean glucose, glucose variability and glucose tolerance were markedly improved compared to baseline in the entire cohort but were significantly lower in patients with optimal graft function.
Optimal early graft function was also associated with prolonged graft survival. “This early outcome,” the researchers observe, “may represent a valuable end point in future clinical trials.”
Although “still in the clinical research stage,” added Dr. Pattou, “islet transplantation may be soon proposed routinely to those suffering from the most severe forms of diabetes.”