Omidubicel for Hematopoietic Cell Transplants: Considerations for Patients and Treatment Outcomes

For patients with hematologic malignancies requiring allogeneic stem cell transplantation, alternative donor sources are needed when lacking access to a matched related or unrelated donor. Umbilical cord blood (UCB) has been an important alternative allograft donor source for these patients; however...

Full description

Saved in:
Bibliographic Details
Published in:Patient preference and adherence 2024-01, Vol.18, p.2217-2223
Main Authors: Morse, Allison L, Kurz, Hana, Moore, Donald C
Format: Article
Language:English
Subjects:
Antithymocyte globulin
cellular therapy
Drug approval
hematology
hematopoietic cell transplant
Hematopoietic stem cells
Niacinamide
omidubicel
Review
Stem cells
Transplantation
Transplantation of organs, tissues, etc
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by
cites cdi_FETCH-LOGICAL-c364t-f959030fb69c67b0ad8775912f2db81d1f8c38ae68bf6e0d49f591c5c74063cf3
container_end_page 2223
container_issue
container_start_page 2217
container_title Patient preference and adherence
container_volume 18
creator Morse, Allison L
Kurz, Hana
Moore, Donald C
description For patients with hematologic malignancies requiring allogeneic stem cell transplantation, alternative donor sources are needed when lacking access to a matched related or unrelated donor. Umbilical cord blood (UCB) has been an important alternative allograft donor source for these patients; however, several limitations exist. Omidubicel is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from UCB. Omidubicel was approved in May 2023 by the United States Food and Drug Administration based on the results of a Phase III trial comparing it to UCB transplantation in patients with high-risk hematologic malignancies. Median time to neutrophil engraftment was faster with omidubicel compared to UCB transplantation (12 days vs 22 days; p
doi_str_mv 10.2147/PPA.S419253
format article
fullrecord <record><control><sourceid>gale_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_d25bf072668446718cc0dca0c86d5fbd</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A820160200</galeid><doaj_id>oai_doaj_org_article_d25bf072668446718cc0dca0c86d5fbd</doaj_id><sourcerecordid>A820160200</sourcerecordid><originalsourceid>FETCH-LOGICAL-c364t-f959030fb69c67b0ad8775912f2db81d1f8c38ae68bf6e0d49f591c5c74063cf3</originalsourceid><addsrcrecordid>eNpVkttrFDEUxoMotlaffJcBX4SyNZfJzZeyLNUWCrtgBd9CJpc1ZWayJjOC_71nu2tpn3Jyzpcf5zs5CL0n-IKSVn7ebJYX31uiKWcv0CkhUi6U0j9fPolP0Jta7zEWTFDyGp0wzSkXWJ8iux6Sn7vkQt_EXJrrMNgp73IKU3LNKvR9c1fsWHe9Haf6pVnlsSYfip0SRA9PNhAHKDZ29CAOdhrg2qznyeUh1LfoVbR9De-O5xn68fXqbnW9uF1_u1ktbxeOiXZaRM01Zjh2QjshO2y9kpJrQiP1nSKeROWYskGoLoqAfasjVB13sgVbLrIzdHPg-mzvza6kwZa_JttkHhK5bI0tYKoPxlPeRSypEKpthSTKOeydxU4Jz2PngXV5YO3mbgjegZ9i-2fQ55Ux_TLb_McQwlutCQbCpyOh5N9zqJMZUoUhwxhDnqthhCrJcasVSD8epFsLvaUxZkC6vdwsFcVEYIr3wPODypVcawnxsRuCzX4PDOyBOe4BqD88NfCo_f_x7B-Zh67s</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3128750498</pqid></control><display><type>article</type><title>Omidubicel for Hematopoietic Cell Transplants: Considerations for Patients and Treatment Outcomes</title><source>Taylor &amp; Francis Open Access</source><source>Publicly Available Content Database</source><source>PubMed Central</source><creator>Morse, Allison L ; Kurz, Hana ; Moore, Donald C</creator><creatorcontrib>Morse, Allison L ; Kurz, Hana ; Moore, Donald C</creatorcontrib><description>For patients with hematologic malignancies requiring allogeneic stem cell transplantation, alternative donor sources are needed when lacking access to a matched related or unrelated donor. Umbilical cord blood (UCB) has been an important alternative allograft donor source for these patients; however, several limitations exist. Omidubicel is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from UCB. Omidubicel was approved in May 2023 by the United States Food and Drug Administration based on the results of a Phase III trial comparing it to UCB transplantation in patients with high-risk hematologic malignancies. Median time to neutrophil engraftment was faster with omidubicel compared to UCB transplantation (12 days vs 22 days; p&lt;0.001). There was also a lower incidence of grade 2/3 bacterial or invasive fungal infections with omidubicel compared to UCB transplantation (37% vs 57%; p=0.027). From a safety perspective, omidubicel has a boxed warning due to the risk of life-threatening infusion reactions, graft-versus-host disease, graft failure, and engraftment syndrome. Omidubicel represents an important advancement in developing novel alternative allograft donor sources. This also has important implications in ensuring access to alternative donor sources for ethnic and minority populations.</description><identifier>ISSN: 1177-889X</identifier><identifier>EISSN: 1177-889X</identifier><identifier>DOI: 10.2147/PPA.S419253</identifier><identifier>PMID: 39525609</identifier><language>eng</language><publisher>New Zealand: Dove Medical Press Limited</publisher><subject>Antithymocyte globulin ; cellular therapy ; Drug approval ; hematology ; hematopoietic cell transplant ; Hematopoietic stem cells ; Niacinamide ; omidubicel ; Review ; Stem cells ; Transplantation ; Transplantation of organs, tissues, etc</subject><ispartof>Patient preference and adherence, 2024-01, Vol.18, p.2217-2223</ispartof><rights>2024 Morse et al.</rights><rights>COPYRIGHT 2024 Dove Medical Press Limited</rights><rights>2024 Morse et al. 2024 Morse et al.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c364t-f959030fb69c67b0ad8775912f2db81d1f8c38ae68bf6e0d49f591c5c74063cf3</cites><orcidid>0000-0001-5629-9505</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/PMC11549910/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549910/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,37013,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39525609$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Morse, Allison L</creatorcontrib><creatorcontrib>Kurz, Hana</creatorcontrib><creatorcontrib>Moore, Donald C</creatorcontrib><title>Omidubicel for Hematopoietic Cell Transplants: Considerations for Patients and Treatment Outcomes</title><title>Patient preference and adherence</title><addtitle>Patient Prefer Adherence</addtitle><description>For patients with hematologic malignancies requiring allogeneic stem cell transplantation, alternative donor sources are needed when lacking access to a matched related or unrelated donor. Umbilical cord blood (UCB) has been an important alternative allograft donor source for these patients; however, several limitations exist. Omidubicel is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from UCB. Omidubicel was approved in May 2023 by the United States Food and Drug Administration based on the results of a Phase III trial comparing it to UCB transplantation in patients with high-risk hematologic malignancies. Median time to neutrophil engraftment was faster with omidubicel compared to UCB transplantation (12 days vs 22 days; p&lt;0.001). There was also a lower incidence of grade 2/3 bacterial or invasive fungal infections with omidubicel compared to UCB transplantation (37% vs 57%; p=0.027). From a safety perspective, omidubicel has a boxed warning due to the risk of life-threatening infusion reactions, graft-versus-host disease, graft failure, and engraftment syndrome. Omidubicel represents an important advancement in developing novel alternative allograft donor sources. This also has important implications in ensuring access to alternative donor sources for ethnic and minority populations.</description><subject>Antithymocyte globulin</subject><subject>cellular therapy</subject><subject>Drug approval</subject><subject>hematology</subject><subject>hematopoietic cell transplant</subject><subject>Hematopoietic stem cells</subject><subject>Niacinamide</subject><subject>omidubicel</subject><subject>Review</subject><subject>Stem cells</subject><subject>Transplantation</subject><subject>Transplantation of organs, tissues, etc</subject><issn>1177-889X</issn><issn>1177-889X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNpVkttrFDEUxoMotlaffJcBX4SyNZfJzZeyLNUWCrtgBd9CJpc1ZWayJjOC_71nu2tpn3Jyzpcf5zs5CL0n-IKSVn7ebJYX31uiKWcv0CkhUi6U0j9fPolP0Jta7zEWTFDyGp0wzSkXWJ8iux6Sn7vkQt_EXJrrMNgp73IKU3LNKvR9c1fsWHe9Haf6pVnlsSYfip0SRA9PNhAHKDZ29CAOdhrg2qznyeUh1LfoVbR9De-O5xn68fXqbnW9uF1_u1ktbxeOiXZaRM01Zjh2QjshO2y9kpJrQiP1nSKeROWYskGoLoqAfasjVB13sgVbLrIzdHPg-mzvza6kwZa_JttkHhK5bI0tYKoPxlPeRSypEKpthSTKOeydxU4Jz2PngXV5YO3mbgjegZ9i-2fQ55Ux_TLb_McQwlutCQbCpyOh5N9zqJMZUoUhwxhDnqthhCrJcasVSD8epFsLvaUxZkC6vdwsFcVEYIr3wPODypVcawnxsRuCzX4PDOyBOe4BqD88NfCo_f_x7B-Zh67s</recordid><startdate>20240101</startdate><enddate>20240101</enddate><creator>Morse, Allison L</creator><creator>Kurz, Hana</creator><creator>Moore, Donald C</creator><general>Dove Medical Press Limited</general><general>Dove</general><general>Dove Medical Press</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0001-5629-9505</orcidid></search><sort><creationdate>20240101</creationdate><title>Omidubicel for Hematopoietic Cell Transplants: Considerations for Patients and Treatment Outcomes</title><author>Morse, Allison L ; Kurz, Hana ; Moore, Donald C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c364t-f959030fb69c67b0ad8775912f2db81d1f8c38ae68bf6e0d49f591c5c74063cf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Antithymocyte globulin</topic><topic>cellular therapy</topic><topic>Drug approval</topic><topic>hematology</topic><topic>hematopoietic cell transplant</topic><topic>Hematopoietic stem cells</topic><topic>Niacinamide</topic><topic>omidubicel</topic><topic>Review</topic><topic>Stem cells</topic><topic>Transplantation</topic><topic>Transplantation of organs, tissues, etc</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Morse, Allison L</creatorcontrib><creatorcontrib>Kurz, Hana</creatorcontrib><creatorcontrib>Moore, Donald C</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Patient preference and adherence</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Morse, Allison L</au><au>Kurz, Hana</au><au>Moore, Donald C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Omidubicel for Hematopoietic Cell Transplants: Considerations for Patients and Treatment Outcomes</atitle><jtitle>Patient preference and adherence</jtitle><addtitle>Patient Prefer Adherence</addtitle><date>2024-01-01</date><risdate>2024</risdate><volume>18</volume><spage>2217</spage><epage>2223</epage><pages>2217-2223</pages><issn>1177-889X</issn><eissn>1177-889X</eissn><abstract>For patients with hematologic malignancies requiring allogeneic stem cell transplantation, alternative donor sources are needed when lacking access to a matched related or unrelated donor. Umbilical cord blood (UCB) has been an important alternative allograft donor source for these patients; however, several limitations exist. Omidubicel is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from UCB. Omidubicel was approved in May 2023 by the United States Food and Drug Administration based on the results of a Phase III trial comparing it to UCB transplantation in patients with high-risk hematologic malignancies. Median time to neutrophil engraftment was faster with omidubicel compared to UCB transplantation (12 days vs 22 days; p&lt;0.001). There was also a lower incidence of grade 2/3 bacterial or invasive fungal infections with omidubicel compared to UCB transplantation (37% vs 57%; p=0.027). From a safety perspective, omidubicel has a boxed warning due to the risk of life-threatening infusion reactions, graft-versus-host disease, graft failure, and engraftment syndrome. Omidubicel represents an important advancement in developing novel alternative allograft donor sources. This also has important implications in ensuring access to alternative donor sources for ethnic and minority populations.</abstract><cop>New Zealand</cop><pub>Dove Medical Press Limited</pub><pmid>39525609</pmid><doi>10.2147/PPA.S419253</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0001-5629-9505</orcidid><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 1177-889X
ispartof Patient preference and adherence, 2024-01, Vol.18, p.2217-2223
issn 1177-889X
1177-889X
language eng
recordid cdi_doaj_primary_oai_doaj_org_article_d25bf072668446718cc0dca0c86d5fbd
source Taylor & Francis Open Access; Publicly Available Content Database; PubMed Central
subjects Antithymocyte globulin
cellular therapy
Drug approval
hematology
hematopoietic cell transplant
Hematopoietic stem cells
Niacinamide
omidubicel
Review
Stem cells
Transplantation
Transplantation of organs, tissues, etc
title Omidubicel for Hematopoietic Cell Transplants: Considerations for Patients and Treatment Outcomes
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-27T08%3A58%3A36IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_doaj_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Omidubicel%20for%20Hematopoietic%20Cell%20Transplants:%20Considerations%20for%20Patients%20and%20Treatment%20Outcomes&rft.jtitle=Patient%20preference%20and%20adherence&rft.au=Morse,%20Allison%20L&rft.date=2024-01-01&rft.volume=18&rft.spage=2217&rft.epage=2223&rft.pages=2217-2223&rft.issn=1177-889X&rft.eissn=1177-889X&rft_id=info:doi/10.2147/PPA.S419253&rft_dat=%3Cgale_doaj_%3EA820160200%3C/gale_doaj_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c364t-f959030fb69c67b0ad8775912f2db81d1f8c38ae68bf6e0d49f591c5c74063cf3%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=3128750498&rft_id=info:pmid/39525609&rft_galeid=A820160200&rfr_iscdi=true