Results from the Older Age Cohort in the ProTrans-Young Paediatric Study Expected in Aprilv

ProTrans-Young aims to evaluate the safety and efficacy of ProTrans, umbilical cord mesenchymal stromal cell treatment for newly-diagnosed type 1 diabetes in children and adolescents. The upcoming analysis represents an important interim readout of treatment response within the 12–21 year old age group. The purpose is to examine whether the treatment response in this age group follows the same trend as previously observed in adult patients. Results from the earlier ProTrans-T1D study in adults were published in 2023 in Diabetologia, the official journal of the European Association for the Study of Diabetes (EASD; Carlsson et al., 2023).

It is important to note that the analysis of this subgroup will not include in-depth statistical testing, such as significance assessment using p-values. This decision has been made to ensure the statistical integrity of the study. Repeated analyses within a study can increase the risk of false-positive results, which is typically managed by adjusting the significance level (alpha). However, such an adjustment can reduce the study’s ability to detect true effects. To avoid this issue, the analysis is therefore limited to an overall trend assessment at this point.

Recruitment is ongoing for the younger age cohort in the ProTrans-Young study, children aged 7–11 years, with the goal of including all patients before the summer of 2025.

The study is being conducted in collaboration with Uppsala University under the leadership of Professor Per-Ola Carlsson, together with co-investigators Johnny Ludvigsson at Linköping University and Helena Elding Larsson at Lund University. Uppsala Clinical Research Center is responsible for data management.