{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T16:13:08Z","timestamp":1791216788787,"version":"4.1.0"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"10","license":[{"start":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T00:00:00Z","timestamp":1786924800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T00:00:00Z","timestamp":1786924800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000901","name":"Juvenile Diabetes Research Foundation International","doi-asserted-by":"publisher","award":["GNT 201302657"],"award-info":[{"award-number":["GNT 201302657"]}],"id":[{"id":"10.13039\/100000901","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001774","name":"The University of Sydney","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100001774","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Diabetologia"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims\/hypothesis<\/jats:title>\n                    <jats:p>Islet transplantation is an appropriate treatment for selected individuals with type 1 diabetes mellitus and hypoglycaemia unawareness. The gold standard of maintenance immunosuppression to prevent allograft rejection is calcineurin inhibitor-based therapy; however, side effects warrant exploration of alternative immunosuppression. The co-stimulatory blocker belatacept and the mammalian target of rapamycin inhibitor sirolimus have demonstrated clinical benefit in solid organ transplantation, but efficacy in human islet transplantation is unknown.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We conducted a non-randomised, phase 2, multi-centre, open-label clinical study. Participants with type 1 diabetes receiving at least one islet transplant were treated with belatacept\/sirolimus (bela\/siro) and compared with a contemporaneous cohort treated with tacrolimus\/mycophenolate mofetil (tac\/MMF). The primary outcome was freedom from hypoglycaemia, with positive C-peptide and HbA\n                      <jats:sub>1c<\/jats:sub>\n                      &lt;53 mmol\/mol (7.0%) at 12 months after the first transplant. Secondary outcomes included metabolic control (Igls criteria, BETA-2 score), allosensitisation and changes in peripheral blood immune cell populations.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Nine participants with type 1 diabetes received bela\/siro, compared with 24 receiving tac\/MMF. Eight participants (89%) receiving bela\/siro achieved the primary outcome compared with 12 (52%) from the tac\/MMF cohort. HbA\n                      <jats:sub>1c<\/jats:sub>\n                      , HYPO score and insulin requirements were reduced in both groups, although renal function remained unchanged only in the bela\/siro group. Immunosuppression resulted in sustained suppression of all monocyte, NK, T and B cell subsets, although CD4\n                      <jats:sup>+<\/jats:sup>\n                      FOXP3\n                      <jats:sup>+<\/jats:sup>\n                      regulatory T cell proportions were higher in the bela\/siro group.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions\/interpretation<\/jats:title>\n                    <jats:p>Baseline immunosuppression with bela\/siro facilitated early islet engraftment and rates of insulin independence, with less impact on renal function, supporting the rationale for routine use in islet transplantation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ANZCTR.org.au ACTRN12619000268145<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00125-026-06813-3","type":"journal-article","created":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T18:06:28Z","timestamp":1786989988000},"page":"2847-2861","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A multi-centre study of belatacept and sirolimus for islet transplantation"],"prefix":"10.1007","volume":"69","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2456-9544","authenticated-orcid":false,"given":"Natasha M.","family":"Rogers","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3750-220X","authenticated-orcid":false,"given":"Min","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elvira","family":"Jimenez-Vera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugh","family":"Gabor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8969-0076","authenticated-orcid":false,"given":"Preeti P.","family":"Sharma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colleen","family":"Etherton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7038-2302","authenticated-orcid":false,"given":"Tom","family":"Loudovaris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8638-3468","authenticated-orcid":false,"given":"Wayne J.","family":"Hawthorne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9770-4845","authenticated-orcid":false,"given":"Chris J.","family":"Drogemuller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5069-0981","authenticated-orcid":false,"given":"David J.","family":"Torpy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3640-1370","authenticated-orcid":false,"given":"Deborah J.","family":"Holmes-Walker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7695-4394","authenticated-orcid":false,"given":"Brian","family":"Gloss","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2160-1625","authenticated-orcid":false,"given":"Shane T.","family":"Grey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6776-481X","authenticated-orcid":false,"given":"David","family":"Goodman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0342-8179","authenticated-orcid":false,"given":"P. 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The study protocol, statistical analysis plan and analytical code will be available upon publication in response to any reasonable request to the corresponding authors.","order":2,"name":"Ethics","label":"Data availability","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"Open Access funding enabled and organized by CAUL and its Member Institutions. This study was funded by a grant from Breakthrough T1D (formerly known as JDRF, GNT 201302657). The funder of the study had no role in study design, data collection, data analysis, data interpretation or writing the report.","order":3,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"POC declares a position on the scientific advisory boards of Verici and Qihan Biotech. NMR declares honoraria from GlaxoSmithKline for lectures. The authors declare that there are no other relationships or activities that might bias, or be perceived to bias, their work.","order":4,"name":"Ethics","label":"Authors\u2019 relationships and activities","group":{"name":"EthicsHeading","label":"Ethics"}},{"value":"NMR was involved in project administration, supervision, investigation, resources, data curation and writing (reviewing and editing). MH, EJ-V, HG, PPS and CE were involved in data curation. TL was involved in project administration and data curation. WJH, CJD, DJT and DH-W were involved in project administration and investigation. BG conducted the bioinformatics analysis and was involved in data curation. STG was involved in conceptualisation and project administration. DG, PTC, TWK and POC were involved in conceptualisation, project administration and investigation. NMR, MH, EJ-V, PPS, HG, CE, TL and BG accessed and verified the underlying study data. All authors had full access to the data, critically reviewed the manuscript and made the decision to submit for publication. NMR and POC were responsible for final submission of the manuscript for publication, and all authors approved the final version before submission. The guarantors (NMR and POC) accept full responsibility of this work, including the conduct of the study, access to data and the decision to publish this work.","order":5,"name":"Ethics","label":"Contribution statement","group":{"name":"EthicsHeading","label":"Ethics"}}]}}