The first part of the clinical trial with Protrans is a safety part where all patients are children with type-1 diabetes who have now received their treatment at the Uppsala University Hospital. The Data Safety and Monitoring Board consists of Professor Ulf Smith, Sahlgrenska University Hospital, Professor Mikael Rydén, Karolinska Hospital and Professor Anders Fasth, Queen Silvia Children's Hospital. They will evaluate whether it is safe to proceed to the phase II part of the study, based on 3 months of follow-up of six children.
In the phase II part of the study, patients are randomized to ProTrans or placebo (1:1). First, 30 patients in the age group of 12-21 years are treated, after which - provided the recommendation of the Data Safety and Monitoring Board after six months -, another 30 patients in the age group of 7-11 years are included in the study. ProTrans is a cell therapy that balances the immune system and counteracts autoimmune type-1 diabetes. The active substance mesenchymal stromal cells, also called stem cells, are selected from umbilical cord tissue using NextCell's patent-pending selection algorithms.
The principal investigators for the study are professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital with the co-investigators professor Helena Elding Larsson, Skånes University Hospital and professor Johnny Ludvigsson, Linköpings University Hospital. The second part of the study is randomized and placebo-controlled (phase II) and a total of 60 children and adolescents with type-1 diabetes will be treated, of which 30 with ProTrans and 30 with placebo. Recruitment will take place at the three participating hospitals in Uppsala, Linköping and Malmö.
Uppsala University Hospital is the sponsor of the study, which is funded by research grants. NextCell contributes with ProTrans and placebo. In addition, the company will support the trial with logistics, documentation and cell therapy expertise.
Full name of the study is: “A Double-blinded, Randomized, Parallel, Placebo-controlled trial of Wharton´s Jelly-derived Allogeneic Mesenchymal Stromal Cells to treat Type I Diabetes in Children and Adolescents” (EudraCT 2020-004520-42).
For more information about NextCell Pharma AB, please contact
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About NextCell Pharma AB
NextCell is a phase II cell therapy company with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The company is in the processes of establishing its own GMP facility for production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 8,5% in FamicordTX, a CAR-T start-up in oncology and 100% of Cellaviva, Scandinavia's largest stem cell bank for family saving stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).