Allogeneic adipose tissue‐derived stem cells ELIXCYTE® in chronic kidney disease: A phase I study assessing safety and clinical feasibility
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 m2 received one d...
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| Veröffentlicht in: | Journal of cellular and molecular medicine 2022-05, Vol.26 (10), p.2972-2980 |
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| creator | Zheng, Cai‐Mei Chiu, I‐Jen Chen, Yu‐Wei Hsu, Yung‐Ho Hung, Lie‐Yee Wu, Mei‐Yi Lin, Yuh‐Feng Liao, Chia‐Te Hung, Yi‐Pei Tsai, Chia‐Chu Cherng, Yih‐Giun Wu, Mai‐Szu |
| description | 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 m2 received one dose of intravenous allogeneic ADSCs (ELIXCYTE®), as 3 groups: 3 low dose (6.4 × 107 cells in total of 8 ml), 3 middle dose (19.2 × 107 cells in total of 24 ml) and 6 high dose (32.0 × 107 cells in total of 40 ml) of ELIXCYTE® 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 m2 as compared to only 2 subjects in baseline eGFR |
| doi_str_mv | 10.1111/jcmm.17310 |
| format | Article |
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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 m2 as compared to only 2 subjects in baseline eGFR < 30 ml/min/1.73 m2 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.</description><identifier>ISSN: 1582-1838</identifier><identifier>EISSN: 1582-4934</identifier><identifier>DOI: 10.1111/jcmm.17310</identifier><identifier>PMID: 35415928</identifier><language>eng</language><publisher>England: John Wiley & Sons, Inc</publisher><subject>Adipose Tissue ; Adverse events ; allogeneic adipose tissue‐derived stem cells ; Body fat ; chronic kidney disease ; Clinical trials ; Demography ; Drug dosages ; Epidermal growth factor receptors ; estimated glomerular filtration rate ; Feasibility Studies ; Female ; Glomerular filtration rate ; Hematopoietic Stem Cell Transplantation ; Hospitals ; Humans ; Intravenous administration ; Kidney diseases ; Male ; Original ; Oxidative stress ; Patients ; Proteinuria ; Quarantine ; Renal Insufficiency, Chronic - drug therapy ; Safety ; Stem cells ; Treatment Outcome</subject><ispartof>Journal of cellular and molecular medicine, 2022-05, Vol.26 (10), p.2972-2980</ispartof><rights>2022 The Authors. published by Foundation for Cellular and Molecular Medicine and John Wiley & Sons Ltd.</rights><rights>2022 The Authors. Journal of Cellular and Molecular Medicine published by Foundation for Cellular and Molecular Medicine and John Wiley & Sons Ltd.</rights><rights>2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4480-fb780cd1665f0a54d8be9b30bcb3c4a49dd1fc8a530a37f5d9103c0d133fe0303</citedby><cites>FETCH-LOGICAL-c4480-fb780cd1665f0a54d8be9b30bcb3c4a49dd1fc8a530a37f5d9103c0d133fe0303</cites><orcidid>0000-0003-0370-3951</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097837/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9097837/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,1417,11562,27924,27925,45574,45575,46052,46476,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35415928$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zheng, Cai‐Mei</creatorcontrib><creatorcontrib>Chiu, I‐Jen</creatorcontrib><creatorcontrib>Chen, Yu‐Wei</creatorcontrib><creatorcontrib>Hsu, Yung‐Ho</creatorcontrib><creatorcontrib>Hung, Lie‐Yee</creatorcontrib><creatorcontrib>Wu, Mei‐Yi</creatorcontrib><creatorcontrib>Lin, Yuh‐Feng</creatorcontrib><creatorcontrib>Liao, Chia‐Te</creatorcontrib><creatorcontrib>Hung, Yi‐Pei</creatorcontrib><creatorcontrib>Tsai, Chia‐Chu</creatorcontrib><creatorcontrib>Cherng, Yih‐Giun</creatorcontrib><creatorcontrib>Wu, Mai‐Szu</creatorcontrib><title>Allogeneic adipose tissue‐derived stem cells ELIXCYTE® in chronic kidney disease: A phase I study assessing safety and clinical feasibility</title><title>Journal of cellular and molecular medicine</title><addtitle>J Cell Mol Med</addtitle><description>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 m2 received one dose of intravenous allogeneic ADSCs (ELIXCYTE®), as 3 groups: 3 low dose (6.4 × 107 cells in total of 8 ml), 3 middle dose (19.2 × 107 cells in total of 24 ml) and 6 high dose (32.0 × 107 cells in total of 40 ml) of ELIXCYTE® 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 m2 as compared to only 2 subjects in baseline eGFR < 30 ml/min/1.73 m2 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.</description><subject>Adipose Tissue</subject><subject>Adverse events</subject><subject>allogeneic adipose tissue‐derived stem cells</subject><subject>Body fat</subject><subject>chronic kidney disease</subject><subject>Clinical trials</subject><subject>Demography</subject><subject>Drug dosages</subject><subject>Epidermal growth factor receptors</subject><subject>estimated glomerular filtration rate</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Glomerular filtration rate</subject><subject>Hematopoietic Stem Cell Transplantation</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Intravenous administration</subject><subject>Kidney diseases</subject><subject>Male</subject><subject>Original</subject><subject>Oxidative stress</subject><subject>Patients</subject><subject>Proteinuria</subject><subject>Quarantine</subject><subject>Renal Insufficiency, Chronic - 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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 m2 as compared to only 2 subjects in baseline eGFR < 30 ml/min/1.73 m2 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.</abstract><cop>England</cop><pub>John Wiley & Sons, Inc</pub><pmid>35415928</pmid><doi>10.1111/jcmm.17310</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0003-0370-3951</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Adipose Tissue Adverse events allogeneic adipose tissue‐derived stem cells Body fat chronic kidney disease Clinical trials Demography Drug dosages Epidermal growth factor receptors estimated glomerular filtration rate Feasibility Studies Female Glomerular filtration rate Hematopoietic Stem Cell Transplantation Hospitals Humans Intravenous administration Kidney diseases Male Original Oxidative stress Patients Proteinuria Quarantine Renal Insufficiency, Chronic - drug therapy Safety Stem cells Treatment Outcome |
| title | Allogeneic adipose tissue‐derived stem cells ELIXCYTE® in chronic kidney disease: A phase I study assessing safety and clinical feasibility |
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