{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T02:39:00Z","timestamp":1790735940392,"version":"4.1.0"},"reference-count":31,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,8,3]],"date-time":"2023-08-03T00:00:00Z","timestamp":1691020800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Transplantation"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>While kidney transplantation (KTx) has traditionally required lifelong immunosuppression, an investigational stem cell therapy, FCR001, has been demonstrated to induce tolerance and eliminate the need for immunosuppression through the establishment of persistent mixed chimerism in a phase 2 clinical study. Real\u2010world evidence (RWE) methods were employed to compare the safety and efficacy of non\u2010myeloablative conditioning with FCR001 with standard of care [SOC] immunosuppression in a retrospective single\u2010center analysis of outcomes among propensity score matched living\u2010donor KTx receiving SOC (<jats:italic>n<\/jats:italic>\u00a0=\u00a0144) or FCR001 (<jats:italic>n<\/jats:italic>\u00a0=\u00a036). Among the FCR001 recipients, 26 (72%) developed persistent chimerism allowing durable elimination of all immunosuppression. There was no significant difference in the composite primary endpoint (biopsy\u2010proven acute rejection [BPAR], graft loss, or death) at 60 months (FCR001 27.8%, <jats:italic>n<\/jats:italic>\u00a0=\u00a010 and SOC 28.5%, <jats:italic>n<\/jats:italic>\u00a0=\u00a041; <jats:italic>p<\/jats:italic>\u00a0=\u00a0.9). FCR001 recipients demonstrated superior kidney function at 5 years (estimated glomerular filtration rate [eGFR] [mean\u00a0\u00b1\u00a0standard deviation]: 64.1\u00a0\u00b1\u00a015.3) compared to SOC (51.7\u00a0\u00b1\u00a018.8; <jats:italic>p<\/jats:italic>\u00a0=\u00a0.02). At 5 years, FCR001 recipients experienced fewer complications including new\u2010onset diabetes post\u2010transplant, although two patients developed graft versus host disease. In conclusion, RWE demonstrated that KTx combined with non\u2010myeloablative conditioning and FCR001 resulting in superior kidney function without increasing the risk of rejection, graft loss, or death among patients off immunosuppression.<\/jats:p>","DOI":"10.1111\/ctr.15074","type":"journal-article","created":{"date-parts":[[2023,8,3]],"date-time":"2023-08-03T09:18:10Z","timestamp":1691054290000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Immune tolerance via FCR001 cell therapy compared with maintenance immunosuppression for kidney transplantation: Real\u2010world evidence analysis of safety and efficacy"],"prefix":"10.1111","volume":"37","author":[{"given":"Nancy","family":"Krieger","sequence":"first","affiliation":[{"name":"Talaris Therapeutics, Inc. Wellesley Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4798-2377","authenticated-orcid":false,"given":"Lawrence","family":"Chodoff","sequence":"additional","affiliation":[{"name":"Talaris Therapeutics, Inc. Wellesley Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1604-9207","authenticated-orcid":false,"given":"Joseph R.","family":"Leventhal","sequence":"additional","affiliation":[{"name":"SURGERY Northwestern Medicine Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1856-2234","authenticated-orcid":false,"given":"Bing","family":"Ho","sequence":"additional","affiliation":[{"name":"Comprehensive Transplant Ctr Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4659-3863","authenticated-orcid":false,"given":"Margaret","family":"Richards","sequence":"additional","affiliation":[{"name":"Evidera Bethesda Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3368-6569","authenticated-orcid":false,"given":"Debra A.","family":"Schaumberg","sequence":"additional","affiliation":[{"name":"Evidera Bethesda Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6461-8761","authenticated-orcid":false,"given":"Douglas","family":"Laidlaw","sequence":"additional","affiliation":[{"name":"Talaris Therapeutics, Inc. 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