Safety and efficacy of the therapy with CD4 + CD25highCD127 ‐T regulatory cells: When paediatric patient becomes adult
Authors' conclusion
We confirmed the long-term safety and efficacy of the therapy. Due to the superior efficacy profile, the combined treatment with Tregs and antiCD20 antibody should be considered as a routine therapy for recent-onset type 1 diabetes patients.
Study context
- Population
- Participants of three trials of Tregs in recently diagnosed T1D children, re-examined 7.5–12 years after Treg exposure
- Participants
- 51 participants
- Comparison
- Tregs vs standard of care
- Tregs+antiCD20n = 9
- Tregs 1 dosen = 10
- Tregs 2 dosesn = 8
- SoC controln = 24reference
Methodological detailsOver 700 variables analysed
- Over 700 variables analysed
Primary result
As reported in the abstract
Long-term efficacy: C-peptide secretion in mixed-meal tolerance test, time of insulin independence and remission
- Tregs+antiCD20 superior to SoC control in C-peptide secretion in mixed-meal tolerance test, time of insulin independence and remission
- No clinically relevant between-group differences in other examinations
Safety
- No severe adverse effects including tumors or deaths reported
Original publication
Safety and efficacy of the therapy with CD4 + CD25highCD127 ‐T regulatory cells: When paediatric patient becomes adult. Diabetes Obes Metab. Published 26 November 2025. doi:10.
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