Safety and efficacy of the therapy with CD4 + CD25highCD127-T regulatory cells: When paediatric patient becomes adult
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View abstract on PubMed
Summary
This summary is machine-generated.Regulatory T cells (Tregs) show long-term safety and efficacy for type 1 diabetes. Combined Treg and anti-CD20 therapy improved C-peptide secretion and insulin independence in children with recent-onset type 1 diabetes.
Area Of Science
- Immunology
- Endocrinology
- Cell Therapy
Background
- CD4+CD25highCD127-T regulatory cells (Tregs) are a potential immunotherapy for type 1 diabetes.
- Previous trials have tested Treg therapy in children with recent-onset type 1 diabetes.
Purpose Of The Study
- To assess the long-term safety and efficacy of Treg therapy for type 1 diabetes.
- To evaluate Treg therapy aspects crucial for regulatory approval.
Main Methods
- Re-examined 51 participants treated with Tregs 7.5-12 years prior.
- Compared Treg subgroups (Tregs+antiCD20, Tregs 1 dose, Tregs 2 doses) with standard of care (SoC).
- Conducted comprehensive diabetes-oriented tests and evaluations of multiple organ systems and safety screening.
Main Results
- The Tregs+antiCD20 group showed superior C-peptide secretion, insulin independence, and remission compared to SoC.
- No clinically significant differences were observed in other examinations between groups.
- No severe adverse events, including tumors or deaths, were reported.
Conclusions
- Long-term safety and efficacy of Treg therapy for type 1 diabetes are confirmed.
- Combined Treg and anti-CD20 antibody treatment demonstrates a superior efficacy profile.
- This combination therapy should be considered for routine use in recent-onset type 1 diabetes patients.
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