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Umbilical cord-derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double-blind placebo-controlled trial by Per-Ola Carlsson; Daniel Espes; Sofia Sisay; Lindsay C. Davies; C. I. Edvard Smith; Mathias G. Svahn is a Medicine article available to read on EtoBox.
What is Umbilical cord-derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double-blind placebo-controlled trial about?
## Aim/hypothesis This study aimed to investigate the safety and efficacy of treatment with allogeneic Wharton’s jelly-derived mesenchymal stromal cells (MSCs) in recent-onset type 1 diabetes. ## Methods A combined Phase I/II trial, composed of a dose escalation followed by a randomised double-blind placebo-controlled study in parallel design, was performed in which treatment with allogeneic MSCs produced as an advanced therapy medicinal product (ProTrans) was compared with placebo in adults with newly diagnosed type 1 diabetes. Inclusion criteria were a diagnosis of type 1 diabetes 0.12 nmol/l. Randomisation was performed with a web-based randomisation system, with a randomisation code created prior to the start of the study. The randomisation was made in blocks, with participants randomised to ProTrans or placebo treatment. Randomisation envelopes were kept at the clinic in a locked room, with study staff opening the envelopes at the baseline visits. All participants and study personnel were blinded to group assignment. The study was conducted at Karolinska University Hospital, Stockholm, Sweden. ## Results Three participants were included in each dose cohort during the first pa
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- Author
- Per-Ola Carlsson; Daniel Espes; Sofia Sisay; Lindsay C. Davies; C. I. Edvard Smith; Mathias G. Svahn
- Publisher
- Springer Science and Business Media LLC
- Published
- 2023
- Language
- EN
- Field
- Medicine (Health Sciences)