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A phase I/II uncontrolled study of 15 patients aged 14-31 years, with newly diagnosed type 1 diabetes mellitus, explored the potential of high dose immunosuppression and autologous non-myeloablative transplantation of haematopoietic stem cells for treating this disease.
The first patient to enter the trial in November 2003 stopped using insulin three days before transplantation but had to start again one year after the procedure at a dose two and a half times higher than at baseline. The protocol was changed after this and, unlike the original patient, the remaining participants had no history of ketoacidosis and did not receive glucocorticoids during conditioning. Recruitment ended in July 2006, allowing for a follow-up of 7-36 months (mean 18.8).
Thirteen of the remaining 14 people who entered the study were able to stop using insulin and had improved β cell function as shown by serum concentrations of C peptide. The linked editorial (pp 1599-600) predicts an explosion of studies building on these promising results in the years to come and suggests that we may soon be able to prevent and reverse type 1 diabetes.