PMID- 35415928 OWN - NLM STAT- MEDLINE DCOM- 20220517 LR - 20220721 IS - 1582-4934 (Electronic) IS - 1582-1838 (Print) IS - 1582-1838 (Linking) VI - 26 IP - 10 DP - 2022 May TI - Allogeneic adipose tissue-derived stem cells ELIXCYTE((R)) in chronic kidney disease: A phase I study assessing safety and clinical feasibility. PG - 2972-2980 LID - 10.1111/jcmm.17310 [doi] AB - The purpose of this phase I clinical trial is to assess the safety and tolerability of allogeneic adipose tissue-derived stem cells (ADSCs) among chronic kidney disease (CKD) patients. 12 eligible CKD patients with an estimated glomerular filtration rate (eGFR) of 15-44 ml/min/1.73 m(2) received one dose of intravenous allogeneic ADSCs (ELIXCYTE((R)) ), as 3 groups: 3 low dose (6.4 x 10(7) cells in total of 8 ml), 3 middle dose (19.2 x 10(7) cells in total of 24 ml) and 6 high dose (32.0 x 10(7) cells in total of 40 ml) of ELIXCYTE((R)) and evaluated after 48 weeks. Primary endpoint was the safety profiles in terms of incidence of adverse events (AEs) and serious adverse event (SAE). Two subjects in high dose group experienced a total of 2 treatment-related AEs which are Grade 1 slow speech and Grade 1 bradyphrenia after the infusion. One subject in middle dose group experienced an SAE unlikely related to treatment, grade 2 proteinuria. No fatal AE was reported in this study. An increase in eGFR was observed in 7 out of 12 subjects (58%) at Week 24 and in 6 of 12 subjects (50%) by Week 48. By Week 24, an increase in eGFR by more than 20% among all CKD patients with baseline eGFR >== 30 ml/min/1.73 m(2) as compared to only 2 subjects in baseline eGFR < 30 ml/min/1.73 m(2) group. No significant reduction in proteinuria was noted among all subjects. This phase I trial demonstrated single-dose intravenous ELIXCYTE was well tolerated in moderate-to-severe CKD patients and its preliminary efficacy warrants future studies. CI - (c) 2022 The Authors. Journal of Cellular and Molecular Medicine published by Foundation for Cellular and Molecular Medicine and John Wiley & Sons Ltd. FAU - Zheng, Cai-Mei AU - Zheng CM AUID- ORCID: 0000-0003-0370-3951 AD - Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. AD - Division of Nephrology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - Taipei Medical University-Research Center of Urology and Kidney (TMU-RCUK), School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. FAU - Chiu, I-Jen AU - Chiu IJ AD - Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. AD - Division of Nephrology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - Taipei Medical University-Research Center of Urology and Kidney (TMU-RCUK), School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. FAU - Chen, Yu-Wei AU - Chen YW AD - Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. AD - Division of Nephrology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - Taipei Medical University-Research Center of Urology and Kidney (TMU-RCUK), School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - College of Medicine, Graduate Institute of Clinical Medicine, Taipei Medical University, Taipei, Taiwan. FAU - Hsu, Yung-Ho AU - Hsu YH AD - Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. AD - Division of Nephrology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - Taipei Medical University-Research Center of Urology and Kidney (TMU-RCUK), School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - Division of Nephrology, Department of Internal Medicine, Hsin Kuo Min Hospital, Taipei Medical University, Taoyuan City, Taiwan. FAU - Hung, Lie-Yee AU - Hung LY AD - Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. AD - Division of Nephrology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - Taipei Medical University-Research Center of Urology and Kidney (TMU-RCUK), School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. FAU - Wu, Mei-Yi AU - Wu MY AD - Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. AD - Division of Nephrology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - Taipei Medical University-Research Center of Urology and Kidney (TMU-RCUK), School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - College of Public Health, Institute of Epidemiology and Preventive Medicine, National Taiwan University, Taipei, Taiwan. FAU - Lin, Yuh-Feng AU - Lin YF AD - Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. AD - Division of Nephrology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - Taipei Medical University-Research Center of Urology and Kidney (TMU-RCUK), School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - College of Medicine, Graduate Institute of Clinical Medicine, Taipei Medical University, Taipei, Taiwan. FAU - Liao, Chia-Te AU - Liao CT AD - Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. AD - Division of Nephrology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - Taipei Medical University-Research Center of Urology and Kidney (TMU-RCUK), School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. FAU - Hung, Yi-Pei AU - Hung YP AD - UnicoCell BioMed Co. Ltd., Taipei, Taiwan. FAU - Tsai, Chia-Chu AU - Tsai CC AD - UnicoCell BioMed Co. Ltd., Taipei, Taiwan. FAU - Cherng, Yih-Giun AU - Cherng YG AD - Department of Anesthesiology, Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan. AD - Department of Anesthesiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. FAU - Wu, Mai-Szu AU - Wu MS AD - Division of Nephrology, Department of Internal Medicine, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan. AD - Division of Nephrology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. AD - Taipei Medical University-Research Center of Urology and Kidney (TMU-RCUK), School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. LA - eng SI - ClinicalTrials.gov/NCT02933827 GR - UnicoCell BioMed Co. Ltd./ PT - Clinical Trial, Phase I PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220412 PL - England TA - J Cell Mol Med JT - Journal of cellular and molecular medicine JID - 101083777 SB - IM MH - Adipose Tissue MH - Feasibility Studies MH - Female MH - *Hematopoietic Stem Cell Transplantation MH - Humans MH - Male MH - *Renal Insufficiency, Chronic/drug therapy MH - Treatment Outcome PMC - PMC9097837 OTO - NOTNLM OT - allogeneic adipose tissue-derived stem cells OT - chronic kidney disease OT - estimated glomerular filtration rate COIS- No potential conflict of interest was reported by the authors. EDAT- 2022/04/14 06:00 MHDA- 2022/05/18 06:00 PMCR- 2022/05/01 CRDT- 2022/04/13 05:39 PHST- 2022/03/07 00:00 [revised] PHST- 2021/07/03 00:00 [received] PHST- 2022/03/14 00:00 [accepted] PHST- 2022/04/14 06:00 [pubmed] PHST- 2022/05/18 06:00 [medline] PHST- 2022/04/13 05:39 [entrez] PHST- 2022/05/01 00:00 [pmc-release] AID - JCMM17310 [pii] AID - 10.1111/jcmm.17310 [doi] PST - ppublish SO - J Cell Mol Med. 2022 May;26(10):2972-2980. doi: 10.1111/jcmm.17310. Epub 2022 Apr 12.