NextCell Pharma AB has completed dosing of all patients in its ongoing ProTrans-Young clinical trial. The study is evaluating the safety and efficacy of ProTrans, NextCell’s lead cell therapy candidate, in pediatric and adolescent patients recently diagnosed with type 1 diabetes.
ProTrans is an allogeneic mesenchymal stem cell product, and the company reports that these cells are selected through its proprietary algorithm designed to identify cells with the optimal immunomodulatory function. It is being developed as a single-dose, off-the-shelf infusion therapy intended to modulate the immune system and preserve residual beta cell function in autoimmune diabetes.
The study began with an open-label safety phase involving six children (three aged 12–18 years and three aged 7–11 years), followed by three months of safety follow-up. Subsequently, 30 patients aged 12–21 years joined a randomized, placebo-controlled, double-blinded phase, assigned 1:1 to either ProTrans or placebo.
One-year follow-up data reported in April 2025 indicated a positive trend in preserving insulin production. However, remission was unexpectedly prolonged in both treatment and placebo groups at the one-year mark, making the full treatment effect difficult to assess at this stage. The company notes that previous adult trials suggest treatment differences will become more apparent as remission naturally ends.
The final cohort, consisting of 30 patients aged 7–11 years, has now also completed treatment, with participants randomized 1:1 between ProTrans and placebo. One-year follow-up data from the entire study population is expected after the summer of 2026.
CEO Mathias Svahn commented: “We are pleased to have completed treatment of all patients in the ProTrans-Young study. This is an important milestone in our mission to develop a disease-modifying therapy for children with type 1 diabetes. We are very impressed by the work of the study teams and deeply grateful to the participating patients and their families for their trust.”
