Approval from the Medical Products Agency and the Swedish Ethical Review Authority to conduct a clinical drug trial
Pediatric diabetes study with stem cells approved
NextCell Pharma AB (“NextCell”) announces today that Uppsala University Hospital and the principal investigator, Professor Per-Ola Carlsson, have been granted approval from the Medical Products Agency and the Swedish Ethical Review Authority to conduct a clinical drug trial with ProTrans™ to treat children and adolescents with type-1 diabetes. The study is a phase I / II study with a total of 66 patients. The first six patients treated will be evaluated for safety. The first six patients, three adolescents (12-18 years) and three children (7-11 years), will be treated and assessed for safety. After that, a randomized, placebo-controlled phase will be performed to evaluate the treatment efficacy.
Professor Per-Ola Carlsson previously presented at the World Diabetes Day 2020 in Lund (https://youtu.be/BN-v8KCvxqQ) that Uppsala University Hospital planned to sponsor a diabetes study with ProTrans together with co-investigators Professor Helena Elding Larsson, Skåne University Hospital and Professor Johnny Ludvigsson, Linköping University Hospital. The study entitled: “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) is now approved.
NextCell intends, together with Professor Per-Ola Carlsson, to present the study more in detail in the coming weeks.
NextCells drug candidate, ProTrans, is a mesenchymal stromal cell therapy, used for treatment of type-1 diabetes by preventing the loss of the insulin-producing beta cells. ProTrans-1 and ProTrans-2 trials, phase 1 and 2 studies, have shown that ProTrans treatment had a protective effect on a beta cells without giving any serious side effects. For safety reasons, only adult patients have been treated in these initial studies, although it is most common to be diagnosed with type 1 diabetes at the age of 10-12.
This pediatric study can significantly increase the market potential for ProTrans as half of all patients diagnosed with Type I diabetes are under 18 years of age. It is a large phase I / II study, particularly for a cell therapy, and the data will be valuable in future application for market approval. NextCell will contribute ProTrans and placebo to the study. In addition, the company will support with logistics, documentation, and expertise. No additional monetary compensation is paid.
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For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Sofia Fredrikson, CFO
Phone: 08-735 5595
E-mail: info@nextcellpharma.com
Website:
www.nextcellpharma.com, www.cellaviva.se
www.cellaviva.dk
About NextCell Pharma AB
NextCell is a Phase II cell therapy company with the lead candidate ProTrans™, for the treatment of type-1 diabetes. Focus is to take ProTrans™ to market approval via a phase III study. Furthermore, NextCell operates Cellaviva, Scandinavia’s largest stem cell bank for family-saving of stem cells from umbilical cord blood and umbilical cord tissue with permission from IVO.
