16 September 2026 editorial review · Trial
Tregs plus anti-CD20 rituximab in pediatric stage 1 T1D: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Primary-agent trial review — 16 September 2026
Assessment: Summary, current status, primary endpoint and key eligibility compared with the current registry. No additional discrepancy confirmed in that comparison. Historical outcome details beyond the primary sources explicitly discussed in the specialist ledgers were not all independently reverified.
Registry: NCT06688331; RECRUITING; updated 2026-07-17; enrollment 150 (ESTIMATED); results not posted.
Endpoint comparison: % of participants in each group who are still in stage 1 type 1 diabetes mellitus, i.e., presence of autoantibodies and normoglycemia or in stage 2 type 1 diabetes mellitus, i.e., presence of autoantibodies, dysglycemia or stage 3 at the end of the trial (From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60); Number of adverse events reported 1 year, 2 years after the first dose of Tregs and at the end of the trial comparing to control arms (From enrollment to the end of participation in the trial at month 60 (day "0" is the day of administration of the first dose of Treg preparation)).
Sources for this record: Treatment of Presymptomatic Stage 1 Type 1 Diabetes Pediatric Patients With Treg Cell Preparations and Anti-CD20 Antibody (registry).
Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.