{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T23:54:57Z","timestamp":1769126097559,"version":"3.49.0"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2026,1,20]],"date-time":"2026-01-20T00:00:00Z","timestamp":1768867200000},"content-version":"vor","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"UnicoCell Biomed CO., LTD"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Chronic kidney disease (CKD) poses a significant global health burden by reducing quality of life and increasing mortality. Current therapies remain inadequate in halting its progression, necessitating novel treatments to improve outcomes. Adipose-derived stem cells (ADSCs) have emerged as a promising therapeutic option. Phase I\/II clinical trials evaluated the efficacy, safety, and tolerability of ELIXCYTE in slowing CKD progression. This multicenter, randomized, open-label study monitored estimated glomerular filtration rate (eGFR) changes over a 48-week period following a single intravenous infusion of ADSCs. Participants were allocated to one of three dosage groups, with primary outcomes assessing eGFR changes and secondary outcomes focusing on safety and tolerability. Results confirmed a favorable safety profile, with no dose-limiting toxicities observed in the low- and moderate-dose groups. Group-based trajectory modeling (GBTM) indicated that, overall, 88.24% of patients exhibited a trend of improvement or stabilization. In the low-dose group, 72.23% of patients demonstrated a stable trend, which was more consistent than in other dosage groups. Furthermore, patients with CKD stage 3B showed a numerically higher proportion of improving trajectories compared to those with stage 4 disease. The low-dose ADSC group exhibited a trend toward more favorable renal function trajectories and fewer adverse events than higher doses, suggesting that lower dosing may provide a balanced profile of safety and potential efficacy. However, despite the preliminary results indicating that ELIXCYTE may effectively slow CKD progression, further large-scale clinical trials are necessary to corroborate these findings and verify the efficacy of ADSC treatment.<\/jats:p>","DOI":"10.1093\/stcltm\/szaf076","type":"journal-article","created":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T12:29:00Z","timestamp":1766406540000},"source":"Crossref","is-referenced-by-count":0,"title":["Clinical efficacy and safety of allogeneic adipose-derived stem cells ELIXCYTE in chronic kidney disease: a phase I\/II study"],"prefix":"10.1093","volume":"15","author":[{"given":"Yi-Chun","family":"Lin","sequence":"first","affiliation":[{"name":"School of Public Health, Taipei Medical University , Taipei,","place":["Taiwan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi-Pei","family":"Hung","sequence":"additional","affiliation":[{"name":"UnicoCell Biomed CO., LTD ., Taipei,","place":["Taiwan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ya-Chung","family":"Tian","sequence":"additional","affiliation":[{"name":"Kidney Research Center and Department of Nephrology, Linkou Chang Gung Memorial Hospital , Taoyuan,","place":["Taiwan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ming-Ju","family":"Wu","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital , Taichung,","place":["Taiwan"]},{"name":"Department of Post-Baccalaureate Medicine, College of Medicine, National Chung Hsing University , Taichung,","place":["Taiwan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Han-Chun","family":"Lin","sequence":"additional","affiliation":[{"name":"Institute of Population Health Sciences, National Health Research Institutes , Miaoli,","place":["Taiwan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Szu-Ying","family":"Chen","sequence":"additional","affiliation":[{"name":"Institute of Population Health Sciences, National Health Research Institutes , Miaoli,","place":["Taiwan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mai-Szu","family":"Wu","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University , Taipei,","place":["Taiwan"]},{"name":"Taipei Medical University Research Center of Urology and Kidney, Taipei Medical University , Taipei,","place":["Taiwan"]},{"name":"Division of Nephrology, Department of Internal Medicine, Shuang Ho Hospital, Taipei Medical University , New Taipei City,","place":["Taiwan"]},{"name":"Master Program in Clinical Genomics and Proteomics, School of Pharmacy, Taipei Medical University , Taipei,","place":["Taiwan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4545-9697","authenticated-orcid":false,"given":"Hung-Yi","family":"Chiou","sequence":"additional","affiliation":[{"name":"School of Public Health, Taipei Medical University , Taipei,","place":["Taiwan"]},{"name":"Institute of Population Health Sciences, National Health Research Institutes , Miaoli,","place":["Taiwan"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2026,1,20]]},"reference":[{"key":"2026011923032008100_szaf076-B1","doi-asserted-by":"crossref","first-page":"e0158765","DOI":"10.1371\/journal.pone.0158765","article-title":"Global prevalence of chronic kidney disease\u2013a systematic review and meta-analysis","volume":"11","author":"Hill","year":"2016","journal-title":"PLoS 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