{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T00:44:33Z","timestamp":1785199473327,"version":"3.55.0"},"reference-count":35,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T00:00:00Z","timestamp":1764115200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T00:00:00Z","timestamp":1764115200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100023181","name":"Agencja Bada\u0144 Medycznych","doi-asserted-by":"publisher","award":["2022\/ABM\/05\/00001\u201000"],"award-info":[{"award-number":["2022\/ABM\/05\/00001\u201000"]}],"id":[{"id":"10.13039\/501100023181","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>\n                      <jats:styled-content style=\"fixed-case\">CD4<\/jats:styled-content>\n                      \u2009+\u2009\n                      <jats:styled-content style=\"fixed-case\">CD25highCD127<\/jats:styled-content>\n                      \u2010T 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\u2010term safety and efficacy aspects important in the authorisation of this therapy.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>\n                      We re\u2010examined 51 participants exposed to Treg therapy between 7.5 and 12\u2009years prior to assessment. Based on previous assignments, we assessed the following subgroups treated with Tregs and anti\u2010\n                      <jats:styled-content style=\"fixed-case\">CD20<\/jats:styled-content>\n                      antibody (Tregs+\n                      <jats:styled-content style=\"fixed-case\">antiCD20<\/jats:styled-content>\n                      ,\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u20099), with 1 or 2 doses of Tregs only (Tregs 1 dose,\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200910 and Tregs 2 doses,\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u20098). The exposed participants were compared with those who received standard of care therapy (\n                      <jats:styled-content style=\"fixed-case\">SoC<\/jats:styled-content>\n                      control,\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u200924) as part of previous studies. The patients underwent diabetes\u2010oriented tests as well as non\u2010 to minimal invasive evaluation of the anatomy and function of the eye, micro\u2010 and microcirculation, endocrine system, genitourinary tract and fertility, kidney and liver profiles, detailed biochemistry lab tests and safety screening. Over 700 variables were analysed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Tregs+\n                      <jats:styled-content style=\"fixed-case\">antiCD20<\/jats:styled-content>\n                      group was superior to\n                      <jats:styled-content style=\"fixed-case\">SoC<\/jats:styled-content>\n                      control group in terms of C\u2010peptide secretion in mixed\u2010meal tolerance test, the time of insulin independence and remission. No clinically relevant between\u2010groups differences were found in other performed examinations. Importantly, no severe adverse effects including tumors or deaths were reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      We confirmed the long\u2010term safety and efficacy of the therapy. Due to the superior efficacy profile, the combined treatment with Tregs and\n                      <jats:styled-content style=\"fixed-case\">antiCD20<\/jats:styled-content>\n                      antibody should be considered as a routine therapy for recent\u2010onset type 1 diabetes patients.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.70330","type":"journal-article","created":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T08:42:46Z","timestamp":1764146566000},"page":"1392-1402","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Safety and efficacy of the therapy with\n                    <scp>CD4<\/scp>\n                    \u2009+\u2009\n                    <scp>CD25highCD127<\/scp>\n                    \u2010T regulatory cells: When paediatric patient becomes adult"],"prefix":"10.1111","volume":"28","author":[{"given":"Marta","family":"Bandura","sequence":"first","affiliation":[{"name":"Department of Pediatric Diabetology and Endocrinology Medical University of Gda\u0144sk  Gda\u0144sk Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magdalena","family":"Piotrowska\u2010Mieczkowska","sequence":"additional","affiliation":[{"name":"Department of Medical Immunology Medical University of Gda\u0144sk  Gda\u0144sk Poland"},{"name":"Poltreg S.A.  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