Enrolment and randomisation
TYPE 1 DIABETES, RECRUITMENT
Participants were recruited from Uppsala University Hospital, Uppsala, Sweden, collaborating hospitals and by recruitment advertising. The participants were informed about the study by the principal investigator (P-OC) or the co-investigators at Karolinska Trial Alliance’s Phase I clinic, Karolinska University Hospital. All participants were supplied with oral and written information on the study and provided written, informed consent.Inclusion criteria were a diagnosis of type 1 diabetes <2 years before enrolment, age 18–40 years and a fasting plasma C-peptide concentration >0.12 nmol/l. Exclusion criteria were BMI >30 kg/mIn part A of the study, only male participants were included since studies of possible HLA immunisation formed part of the safety analysis. Three participants were treated with low-dose ProTrans (25 million cells), followed by three participants receiving 100 million cells and three participants receiving 200 million cells. Based on the safety results in part A, women were allowed to participate in part B. Randomisation in part B of the study was performed using a web-based randomisation system, in blocks without stratification to either batch 1 ProTrans, batch 2 ProTrans or placebo treatment. All female participants were required to agree to use acceptable birth control (defined as methods with a failure rate of <1% per year when used correctly) to participate.