NextCell Pharma has several ongoing clinical trials with ProTrans. The largest ongoing study ProTrans Young, which includes 66 patients, is progressing well. All 30 patients in the older age group have been recruited and will be treated with ProTrans.

In the long-term follow-up studies ProTrans-Obs and ProTrans-Repeat the first diabetes patients have now completed the studies after five years of follow-up. ProTrans-Young - completed recruitment of the older age group The study was started in 2021 and is an investigator-initiated clinical study led by Uppsala University in collaboration with Linkoping University and Lund University. The goal for this Phase 1/2 study is to evaluate ProTrans for the treatment of paediatric patients newly diagnosed with type 1 diabetes.

All patients in the older age Group have now been recruited and the last patient in this age group is expected to receive treatment in February of this year. After further safety checks, 30 patients in the age group 7-11 will be recruited. That part of the study is expected to begin in August.

ProTrans-Obs - patients will soon be evaluated. ProTrans-Obs is long-term follow-up of 11 patients who previously participated in ProTrans-2. The first diabetes patients will soon have completed the study after being observed for five years. During the summer, all patients will have completed the study, which can then be evaluated.

Of the patients who completed ProTrans-2, 6 ProTrans-treated and 5 placebo-treated patients accepted an invitation to participate in the follow-up study ProTrans-Obs after completion of the ProTrans-2 study. In this study, the patients' own body insulin production is measured every six months, and a follow-up after three years has already been carried out. The result from this interim analysis shows a statistically significant treatment effect on the body's own insulin production at all analysed times up to three years.

Drill University in Montreal, Canada, sponsored a Phase 2 trial for the treatment of patients with severe pneumonia caused by COVID-19. The aim of the study was to include 48 patients who were randomised to ProTrans (24 patients) or placebo (24 patients). The study was terminated by Drill after 19 patients were treated, due to less patients meeting the criteria for inclusion as the vaccine programme was rolled out.

ProTrans-1 - completed Phase 1 study The study was started in January 2018 and completed in 2019. An open-label dose-escalation Phase 1 study in 9 patients with type 1 diabetes. ProTrans's safety and impact on the patient's own insulin production were evaluated by measuring insulin production before and one year after treatment.

The study showed a) good safety, and b) a dose-dependent effect regarding preservation of the body's own insulin production one year after treatment. ProTrans-2 - completed Phase 2 study The study was started in 2019 and completed in 2020. A randomised, double-blinded placebo-controlled Phase 2 study with the main objective of evaluating effectiveness.

The study included fifteen newly diagnosed patients with type 1 diabetes. The results showed that patients treated with ProTrans maintained 90% of their body's own insulin production at the time of treatment one year after treatment, compared to 53% in the placebo group. Data from this study have been published in Diabetologia, the official journal of the European Association for the Study of Diabetes (Carlsson et al.

2023 Aug;66(8):1431-1441).