Safety and efficacy of the therapy with CD4 + CD25highCD127-T regulatory cells: When paediatric patient becomes adult.

ABSTRACT:

Aim

CD4 + 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 methods

We 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. T

SUBMITTER: Bandura M 

PROVIDER: S-EPMC12803574 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature