Efficacy study
The randomised part B of the study was designed for the primary efficacy endpoint of Δ-change in C-peptide AUC at 12 months post treatment. While C-peptide levels were preserved in participants treated with ProTrans (200 million cells), declining by a median of only 10%, there was an median loss of 47% of C-peptide in the placebo-treated group (Fig. Importantly, there was no statistical difference in efficacy between the two different batches of ProTrans product used in part B of the trial (All participants were receiving insulin treatment at inclusion in the trial, with none of them becoming insulin independent during the course of study (data not shown). However, when analysing the ∆-changes in insulin requirements during the year of study, insulin doses in participants treated with ProTrans did not change, while mean increases in insulin doses were observed in the placebo-treated group (Fig. HbA