A prospective, randomized, controlled trial of autologous haematopoietic stem cell transplantation for aggressive multiple sclerosis: a position paper
Background: Haematopoietic stem cell transplantation (HSCT) has been tried in the last 15 years as a therapeutic option in patients with poor-prognosis autoimmune disease who do not respond to conventional treatments. Worldwide, more than 600 patients with multiple sclerosis (MS) have been treated w...
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| Veröffentlicht in: | Multiple sclerosis 2012-06, Vol.18 (6), p.825-834 |
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| creator | Saccardi, R Freedman, MS Sormani, MP Atkins, H Farge, D Griffith, LM Kraft, G Mancardi, GL Nash, R Pasquini, M Martin, R Muraro, PA |
| description | Background: Haematopoietic stem cell transplantation (HSCT) has been tried in the last 15 years as a therapeutic option in patients with poor-prognosis autoimmune disease who do not respond to conventional treatments. Worldwide, more than 600 patients with multiple sclerosis (MS) have been treated with HSCT, most of them having been recruited in small, single-centre, phase 1–2 uncontrolled trials. Clinical and magnetic resonance imaging outcomes from case series reports or Registry-based analyses suggest that a major response is achieved in most patients; quality and duration of response are better in patients transplanted during the relapsing–remitting phase than in those in the secondary progressive stage.
Objectives: An interdisciplinary group of neurologists and haematologists has been formed, following two international meetings supported by the European and American Blood and Marrow Transplantation Societies, for the purpose of discussing a controlled clinical trial, to be designed within the new scenarios of evolving MS treatments.
Conclusions: Objectives of the trial, patient selection, transplant technology and outcome assessment were extensively discussed. The outcome of this process is summarized in the present paper, with the goal of establishing the background and advancing the development of a prospective, randomized, controlled multicentre trial to assess the clinical efficacy of HSCT for the treatment of highly active MS. |
| doi_str_mv | 10.1177/1352458512438454 |
| format | Article |
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Objectives: An interdisciplinary group of neurologists and haematologists has been formed, following two international meetings supported by the European and American Blood and Marrow Transplantation Societies, for the purpose of discussing a controlled clinical trial, to be designed within the new scenarios of evolving MS treatments.
Conclusions: Objectives of the trial, patient selection, transplant technology and outcome assessment were extensively discussed. The outcome of this process is summarized in the present paper, with the goal of establishing the background and advancing the development of a prospective, randomized, controlled multicentre trial to assess the clinical efficacy of HSCT for the treatment of highly active MS.</description><identifier>ISSN: 1352-4585</identifier><identifier>EISSN: 1477-0970</identifier><identifier>DOI: 10.1177/1352458512438454</identifier><identifier>PMID: 22383228</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Adolescent ; Adult ; Autografts ; Autoimmune diseases ; Biological and medical sciences ; Blood ; Clinical trials ; Clinical Trials, Phase III as Topic - methods ; Cooperative Behavior ; Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases ; Disability Evaluation ; Europe ; Hematopoietic Stem Cell Transplantation ; Humans ; International Cooperation ; Magnetic resonance imaging ; Medical sciences ; Middle Aged ; Multicenter Studies as Topic - methods ; Multiple sclerosis ; Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis ; Multiple Sclerosis, Relapsing-Remitting - diagnosis ; Multiple Sclerosis, Relapsing-Remitting - surgery ; Neurology ; Prospective Studies ; Randomized Controlled Trials as Topic - methods ; Research Design ; Research Papers ; Severity of Illness Index ; stem cell transplantation ; Transplantation ; Transplantation, Autologous ; Transplants ; Treatment Outcome ; United States ; Young Adult</subject><ispartof>Multiple sclerosis, 2012-06, Vol.18 (6), p.825-834</ispartof><rights>The Author(s) 2012</rights><rights>2015 INIST-CNRS</rights><rights>SAGE Publications © Jun 2012</rights><rights>The Author(s) 2012 2012 SAGE Publications</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c525t-f521eec0013110794f7819aeb6630c25f33eb78c2066e235cac10c8aeaaa853c3</citedby><cites>FETCH-LOGICAL-c525t-f521eec0013110794f7819aeb6630c25f33eb78c2066e235cac10c8aeaaa853c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/1352458512438454$$EPDF$$P50$$Gsage$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/1352458512438454$$EHTML$$P50$$Gsage$$Hfree_for_read</linktohtml><link.rule.ids>230,314,777,781,882,21800,27905,27906,43602,43603</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25935654$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22383228$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Saccardi, R</creatorcontrib><creatorcontrib>Freedman, MS</creatorcontrib><creatorcontrib>Sormani, MP</creatorcontrib><creatorcontrib>Atkins, H</creatorcontrib><creatorcontrib>Farge, D</creatorcontrib><creatorcontrib>Griffith, LM</creatorcontrib><creatorcontrib>Kraft, G</creatorcontrib><creatorcontrib>Mancardi, GL</creatorcontrib><creatorcontrib>Nash, R</creatorcontrib><creatorcontrib>Pasquini, M</creatorcontrib><creatorcontrib>Martin, R</creatorcontrib><creatorcontrib>Muraro, PA</creatorcontrib><creatorcontrib>Center for International Blood and Marrow Research</creatorcontrib><creatorcontrib>HSCT in MS International Study Group</creatorcontrib><creatorcontrib>European Blood and Marrow Transplantation Group</creatorcontrib><title>A prospective, randomized, controlled trial of autologous haematopoietic stem cell transplantation for aggressive multiple sclerosis: a position paper</title><title>Multiple sclerosis</title><addtitle>Mult Scler</addtitle><description>Background: Haematopoietic stem cell transplantation (HSCT) has been tried in the last 15 years as a therapeutic option in patients with poor-prognosis autoimmune disease who do not respond to conventional treatments. Worldwide, more than 600 patients with multiple sclerosis (MS) have been treated with HSCT, most of them having been recruited in small, single-centre, phase 1–2 uncontrolled trials. Clinical and magnetic resonance imaging outcomes from case series reports or Registry-based analyses suggest that a major response is achieved in most patients; quality and duration of response are better in patients transplanted during the relapsing–remitting phase than in those in the secondary progressive stage.
Objectives: An interdisciplinary group of neurologists and haematologists has been formed, following two international meetings supported by the European and American Blood and Marrow Transplantation Societies, for the purpose of discussing a controlled clinical trial, to be designed within the new scenarios of evolving MS treatments.
Conclusions: Objectives of the trial, patient selection, transplant technology and outcome assessment were extensively discussed. The outcome of this process is summarized in the present paper, with the goal of establishing the background and advancing the development of a prospective, randomized, controlled multicentre trial to assess the clinical efficacy of HSCT for the treatment of highly active MS.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Autografts</subject><subject>Autoimmune diseases</subject><subject>Biological and medical sciences</subject><subject>Blood</subject><subject>Clinical trials</subject><subject>Clinical Trials, Phase III as Topic - methods</subject><subject>Cooperative Behavior</subject><subject>Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases</subject><subject>Disability Evaluation</subject><subject>Europe</subject><subject>Hematopoietic Stem Cell Transplantation</subject><subject>Humans</subject><subject>International Cooperation</subject><subject>Magnetic resonance imaging</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multicenter Studies as Topic - methods</subject><subject>Multiple sclerosis</subject><subject>Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis</subject><subject>Multiple Sclerosis, Relapsing-Remitting - diagnosis</subject><subject>Multiple Sclerosis, Relapsing-Remitting - surgery</subject><subject>Neurology</subject><subject>Prospective Studies</subject><subject>Randomized Controlled Trials as Topic - methods</subject><subject>Research Design</subject><subject>Research Papers</subject><subject>Severity of Illness Index</subject><subject>stem cell transplantation</subject><subject>Transplantation</subject><subject>Transplantation, Autologous</subject><subject>Transplants</subject><subject>Treatment Outcome</subject><subject>United States</subject><subject>Young Adult</subject><issn>1352-4585</issn><issn>1477-0970</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>AFRWT</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNqNkk1rFjEQxxdRbK3ePUlACh66NS-bTdZDoRTfoOBFz8s8eWa3KdlNTLIF_SB-XvO8WGtB6CmB-c1_Zv4zVfWS0VPGlHrLhOSN1JLxRuhGNo-qQ9YoVdNO0cflX8L1Jn5QPUvpmlKqlJBPqwPOhRac68Pq1zkJ0aeAJtsbPCER5rWf7E9cnxDj5xy9c7gmOVpwxA8EluydH_2SyBXgBNkHbzFbQ1LGiRh0rsAwp-BgzpCtn8ngI4FxjJhSqUGmxWUbHJJkHJbaNr0jQEL5bOkAAePz6skALuGL_XtUffvw_uvFp_ryy8fPF-eXtZFc5nqQnCEaSplgjKquGZRmHeCqbQU1XA5C4Eppw2nbIhfSgGHUaEAA0FIYcVSd7XTDsppwbbBMDK4P0U4Qf_QebP9vZLZX_ehveiF0JyktAm_2AtF_XzDlfrJp4wLMWEzqGeVN23Cp-UNQWlbZclnQ1_fQa7_EuTixpRjTuhOFojvKFBdTxOG2b0b7zX309--jpLy6O-9twp-DKMDxHoBkwA1llcamv5zshGy3QvWOSzDi3e7-U_g3isnS_g</recordid><startdate>20120601</startdate><enddate>20120601</enddate><creator>Saccardi, R</creator><creator>Freedman, MS</creator><creator>Sormani, MP</creator><creator>Atkins, H</creator><creator>Farge, D</creator><creator>Griffith, LM</creator><creator>Kraft, G</creator><creator>Mancardi, GL</creator><creator>Nash, R</creator><creator>Pasquini, M</creator><creator>Martin, R</creator><creator>Muraro, PA</creator><general>SAGE Publications</general><general>Sage Publications</general><general>Sage Publications Ltd</general><scope>AFRWT</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20120601</creationdate><title>A prospective, randomized, controlled trial of autologous haematopoietic stem cell transplantation for aggressive multiple sclerosis: a position paper</title><author>Saccardi, R ; Freedman, MS ; Sormani, MP ; Atkins, H ; Farge, D ; Griffith, LM ; Kraft, G ; Mancardi, GL ; Nash, R ; Pasquini, M ; Martin, R ; Muraro, PA</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c525t-f521eec0013110794f7819aeb6630c25f33eb78c2066e235cac10c8aeaaa853c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Autografts</topic><topic>Autoimmune diseases</topic><topic>Biological and medical sciences</topic><topic>Blood</topic><topic>Clinical trials</topic><topic>Clinical Trials, Phase III as Topic - methods</topic><topic>Cooperative Behavior</topic><topic>Degenerative and inherited degenerative diseases of the nervous system. 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Leukoencephalitis</topic><topic>Multiple Sclerosis, Relapsing-Remitting - diagnosis</topic><topic>Multiple Sclerosis, Relapsing-Remitting - surgery</topic><topic>Neurology</topic><topic>Prospective Studies</topic><topic>Randomized Controlled Trials as Topic - methods</topic><topic>Research Design</topic><topic>Research Papers</topic><topic>Severity of Illness Index</topic><topic>stem cell transplantation</topic><topic>Transplantation</topic><topic>Transplantation, Autologous</topic><topic>Transplants</topic><topic>Treatment Outcome</topic><topic>United States</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Saccardi, R</creatorcontrib><creatorcontrib>Freedman, MS</creatorcontrib><creatorcontrib>Sormani, MP</creatorcontrib><creatorcontrib>Atkins, H</creatorcontrib><creatorcontrib>Farge, D</creatorcontrib><creatorcontrib>Griffith, LM</creatorcontrib><creatorcontrib>Kraft, G</creatorcontrib><creatorcontrib>Mancardi, GL</creatorcontrib><creatorcontrib>Nash, R</creatorcontrib><creatorcontrib>Pasquini, M</creatorcontrib><creatorcontrib>Martin, R</creatorcontrib><creatorcontrib>Muraro, PA</creatorcontrib><creatorcontrib>Center for International Blood and Marrow Research</creatorcontrib><creatorcontrib>HSCT in MS International Study Group</creatorcontrib><creatorcontrib>European Blood and Marrow Transplantation Group</creatorcontrib><collection>Sage Journals GOLD Open Access 2024</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Multiple sclerosis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Saccardi, R</au><au>Freedman, MS</au><au>Sormani, MP</au><au>Atkins, H</au><au>Farge, D</au><au>Griffith, LM</au><au>Kraft, G</au><au>Mancardi, GL</au><au>Nash, R</au><au>Pasquini, M</au><au>Martin, R</au><au>Muraro, PA</au><aucorp>Center for International Blood and Marrow Research</aucorp><aucorp>HSCT in MS International Study Group</aucorp><aucorp>European Blood and Marrow Transplantation Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A prospective, randomized, controlled trial of autologous haematopoietic stem cell transplantation for aggressive multiple sclerosis: a position paper</atitle><jtitle>Multiple sclerosis</jtitle><addtitle>Mult Scler</addtitle><date>2012-06-01</date><risdate>2012</risdate><volume>18</volume><issue>6</issue><spage>825</spage><epage>834</epage><pages>825-834</pages><issn>1352-4585</issn><eissn>1477-0970</eissn><abstract>Background: Haematopoietic stem cell transplantation (HSCT) has been tried in the last 15 years as a therapeutic option in patients with poor-prognosis autoimmune disease who do not respond to conventional treatments. Worldwide, more than 600 patients with multiple sclerosis (MS) have been treated with HSCT, most of them having been recruited in small, single-centre, phase 1–2 uncontrolled trials. Clinical and magnetic resonance imaging outcomes from case series reports or Registry-based analyses suggest that a major response is achieved in most patients; quality and duration of response are better in patients transplanted during the relapsing–remitting phase than in those in the secondary progressive stage.
Objectives: An interdisciplinary group of neurologists and haematologists has been formed, following two international meetings supported by the European and American Blood and Marrow Transplantation Societies, for the purpose of discussing a controlled clinical trial, to be designed within the new scenarios of evolving MS treatments.
Conclusions: Objectives of the trial, patient selection, transplant technology and outcome assessment were extensively discussed. The outcome of this process is summarized in the present paper, with the goal of establishing the background and advancing the development of a prospective, randomized, controlled multicentre trial to assess the clinical efficacy of HSCT for the treatment of highly active MS.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>22383228</pmid><doi>10.1177/1352458512438454</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Multiple sclerosis, 2012-06, Vol.18 (6), p.825-834 |
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| source | MEDLINE; SAGE Complete A-Z List |
| subjects | Adolescent Adult Autografts Autoimmune diseases Biological and medical sciences Blood Clinical trials Clinical Trials, Phase III as Topic - methods Cooperative Behavior Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases Disability Evaluation Europe Hematopoietic Stem Cell Transplantation Humans International Cooperation Magnetic resonance imaging Medical sciences Middle Aged Multicenter Studies as Topic - methods Multiple sclerosis Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis Multiple Sclerosis, Relapsing-Remitting - diagnosis Multiple Sclerosis, Relapsing-Remitting - surgery Neurology Prospective Studies Randomized Controlled Trials as Topic - methods Research Design Research Papers Severity of Illness Index stem cell transplantation Transplantation Transplantation, Autologous Transplants Treatment Outcome United States Young Adult |
| title | A prospective, randomized, controlled trial of autologous haematopoietic stem cell transplantation for aggressive multiple sclerosis: a position paper |
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