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A Multicenter, Randomized, Blinded, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Cell Therapy Based With Artificially Expanded CD4+CD25+CD127- Regulatory Lymphocytes and Anti-CD20 Antibody in Pediatric Patients With Presymptomatic Diabetes Type 1 (Stage 1)
Conditions
Interventions
ex vivo expanded CD4+CD25+CD127- regulatory T cells (Tregs)
Anti-CD20 (rituximab)
+2 more
Locations
8
Poland
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku
Bialystok, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach
Katowice, Poland
Uniwersytet Medyczny W Lodzi
Lodz, Poland
Uniwersytecki Szpital Dzieciecy w Lublinie
Lublin, Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Poland
Start Date
March 12, 2025
Primary Completion Date
December 1, 2032
Completion Date
December 1, 2032
Last Updated
January 16, 2026
NCT07222137
NCT06807190
NCT07160816
NCT04786262
NCT03648918
NCT06748963
Lead Sponsor
PolTREG S.A.
Collaborators
Data Source & Attribution
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