ArticleDiabetes, obesity & metabolism2026
Safety and efficacy of the therapy with CD4 + CD25highCD127-T regulatory cells: When paediatric patient becomes adult.
Article in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Reducing Diabetic Ketoacidosis in Pediatric Type 1 Diabetes: The Impact of Screening Programs and Early Disease-Modifying Treatment.Journal of clinical medicine · 2026Review
- The New Wave of Gene and Cell Therapies Across Diseases.Journal of clinical medicine · 2026Review
- Safety and efficacy of the therapy with CD4 + CD25highCD127-T regulatory cells: When paediatric patient becomes adult.Diabetes, obesity & metabolism · 2026Article
Corrections and comments
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Authors and funding
19 authors.
Funding
Abstract
aimCD4 + CD25highCD127-T regulatory cells (Tregs) remain a drug candidate for immunotherapy of type 1 diabetes. We completed three trials testing Tregs in recently diagnosed type 1 diabetes children. Here, we looked for long-term safety and efficacy aspects important in the authorisation of this therapy. MATERIALS AND
methodsWe re-examined 51 participants exposed to Treg therapy between 7.5 and 12 years prior to assessment. Based on previous assignments, we assessed the following subgroups treated with Tregs and anti-CD20 antibody (Tregs+antiCD20, N = 9), with 1 or 2 doses of Tregs only (Tregs 1 dose, N = 10 and Tregs 2 doses, N = 8). The exposed participants were compared with those who received standard of care therapy (SoC control, N = 24) as part of previous studies. The patients underwent diabetes-oriented tests as well as non- to minimal invasive evaluation of the anatomy and function of the eye, micro- and microcirculation, endocrine system, genitourinary tract and fertility, kidney and liver profiles, detailed biochemistry lab tests and safety screening. Over 700 variables were analysed.
resultsTregs+antiCD20 group was superior to SoC control group in terms of C-peptide secretion in mixed-meal tolerance test, the time of insulin independence and remission. No clinically relevant between-groups differences were found in other performed examinations. Importantly, no severe adverse effects including tumors or deaths were reported.
conclusionsWe 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.
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