Condition: Presymptomatic Diabetes Type 1 (Stage 1) · Diabetes Mellitus, Type I · Diabetes Mellitus, Type 1 · Sponsor: PolTREG S.A.
The main purpose of the study is to check: * Can therapy with a preparation of regulatory cells (Tregs lymphocytes) and/or an anti-CD20 antibody preparation (rituximab) be successfully used in children with pre-diabetes to treat or delay type 1 diabetes? * Is therapy with a preparation of regulatory cells (Tregs lymphocytes) and/or a preparation of antiCD20 antibodies (rituximab) safe for children with pre-diabetes, and what side effects may be associated with it? The study will include patients at high risk for type 1 diabetes whose laboratory tests have confirmed preserved normal/high insulin production. First (part 1 of the study), tests will be performed to determine the risk of the disease (determination of autoantibodies that characterize the autoimmune background). In order to confirm the effectiveness of the therapy, not all patients will receive the study treatment. The study will be a so-called blinded randomized trial. This means that in this trial, all participants will undergo the same study procedures, but the participant will be randomly assigned to one of four (4) groups that will receive different treatment regimens before entering the study. The participant will be randomly assigned to one of four groups: * Group I will receive a preparation of regulatory cells (Tregs lymphocytes) along with a preparation of antiCD20 antibodies, * Group II will receive a preparation of regulatory cells (Tregs lymphocytes) together with an inert substance (placebo) * Grou…
This description comes directly from the study's public registry record.
Marta Druch, Clinical Trial Director · +48731471845 · m.druch@poltreg.com
Katarzyna Karpinska, Sr Clinical Trial Specialist · +48537504486 · k.karpinska@poltreg.com
Always discuss trial participation with your own doctor first.
| Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku | Bialystok, Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne | Gdansk, Poland | Recruiting |
| Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W Katowicach | Katowice, Poland | Not Yet Recruiting |
| Uniwersytet Medyczny W Lodzi | Lodz, Poland | Recruiting |
| Uniwersytecki Szpital Dzieciecy w Lublinie | Lublin, Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Opolu | Opole, Poland | Recruiting |
| Centrum Medyczne Medyk Sp. z o.o. S.K. | Rzeszów, Poland | Recruiting |
| Pomorski Uniwersytet Medyczny w Szczecinie | Szczecin, Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu | Wroclaw, Poland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06688331