The first children have been treated in the younger age group of the ProTrans-Young study
NextCell Pharma AB ("NextCell" or the "Company", Nasdaq First North Growth Market: NXTCL), announces that the first four children in the 7–11 year age group have been treated in the latest phase of the ProTrans-Young study. An additional four children have been screened and are expected to begin their treatment shortly. These advancements mark an important milestone in the progress of the study, which is proceeding faster than anticipated.
“There is a high level of interest in the study, and many are signing up from all over the country,” comments Karin Kjellström, research nurse at Uppsala University Hospital. The study aims to evaluate the efficacy and safety of ProTrans, a treatment developed to protect insulin-producing cells, which in this study is being administered for the first time to children and adolescents with newly diagnosed type 1 diabetes.
The ProTrans-Young study is a double-blind, randomized, and placebo-controlled trial divided into two phases. In the first phase (Phase Ib), all patients, including those aged 7–18 years, were treated to ensure the safety of the treatment. The second phase (Phase IIb) includes a total of 60 children and adolescents, with 30 treated with ProTrans and 30 with placebo. The treatment of the first 30 patients aged 12–21 years has already been completed, and the safety data has been thoroughly reviewed and approved by the study’s safety committee.
The purpose of the ProTrans treatment is to halt the autoimmune destruction of insulin-producing cells in children and adolescents, slowing the disease progression and reduce the risk of serious complications associated with type 1 diabetes. The study aims to demonstrate that the treatment can preserve a greater portion of the body’s own insulin production, which would result in improved blood sugar regulation, reduced associated illnesses and thereby a better quality of life for the young patients.
For more information about the study and participation, please visit: NextCell Pharma - Study Information.
Professor Per-Ola Carlsson is the principal investigator for ProTrans-Young and the study is sponsored by Uppsala University. NextCell continues to contribute ProTrans, placebo, as well as support for logistics, documentation, and expert competence. The cells used for the production of ProTrans are of the same type as the cells that the subsidiary Cellaviva collects for family stem cell banking.