Effects of intravascular administration of mesenchymal stromal cells derived from Wharton’s Jelly of the umbilical cord on systemic immunomodulation and neuroinflammation after traumatic brain injury (TRAUMACELL): study protocol for a multicentre randomised controlled trial
IntroductionTraumatic brain injury (TBI) is one of the leading causes of death and disability worldwide. Treatments for TBI patients are limited and none has been shown to provide prolonged and long-term neuroprotective or neurorestorative effects. A growing body of evidence suggests a link between...
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| creator | Sigaut, Stéphanie Tardivon, Coralie Jacquens, Alice Bottlaender, Michel Gervais, Philippe Habert, Marie-Odile Monsel, Antoine Roquilly, Antoine Boutonnet, Mathieu Galanaud, Damien Cras, Audrey Boucher-Pillet, Hélène Florence, Aline-Marie Cavalier, Ines Menasche, Philippe Degos, Vincent Couffignal, Camille |
| description | IntroductionTraumatic brain injury (TBI) is one of the leading causes of death and disability worldwide. Treatments for TBI patients are limited and none has been shown to provide prolonged and long-term neuroprotective or neurorestorative effects. A growing body of evidence suggests a link between TBI-induced neuro-inflammation and neurodegenerative post-traumatic disorders. Consequently, new therapies triggering immunomodulation and promoting neurological recovery are the subject of major research efforts. We hypothesise that repeated intravenous treatment with mesenchymal stromal cells derived from Wharton’s Jelly of the umbilical cord-derived mesenchymal stromal cells ((WJ-UC-MSC) may be associated with a significant decrease of post-TBI neuroinflammation and improvement of neurological status.Methods and analysisThe TRAUMACELL trial is a prospective, national multicentre, phase III, superiority, double-arm comparative randomised (1:1) double-blinded clinical trial. Among patients aged between 18–50, with a severe TBI defined by a Glasgow score less than 12 (within the first 48 hours) with brain traumatic lesion on CT Scan and needing intracranial pressure monitoring, with no other significant organ trauma (abbreviated injury scale |
| doi_str_mv | 10.1136/bmjopen-2024-091441 |
| format | Article |
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Treatments for TBI patients are limited and none has been shown to provide prolonged and long-term neuroprotective or neurorestorative effects. A growing body of evidence suggests a link between TBI-induced neuro-inflammation and neurodegenerative post-traumatic disorders. Consequently, new therapies triggering immunomodulation and promoting neurological recovery are the subject of major research efforts. We hypothesise that repeated intravenous treatment with mesenchymal stromal cells derived from Wharton’s Jelly of the umbilical cord-derived mesenchymal stromal cells ((WJ-UC-MSC) may be associated with a significant decrease of post-TBI neuroinflammation and improvement of neurological status.Methods and analysisThe TRAUMACELL trial is a prospective, national multicentre, phase III, superiority, double-arm comparative randomised (1:1) double-blinded clinical trial. Among patients aged between 18–50, with a severe TBI defined by a Glasgow score less than 12 (within the first 48 hours) with brain traumatic lesion on CT Scan and needing intracranial pressure monitoring, with no other significant organ trauma (abbreviated injury scale<2) and unresponsive to verbal commands after 5 days of sedation discontinuation, 68 will be randomly allocated to receive either WJ-UC-MSC solution or placebo, with three intravenous injections 1 week apart. The primary outcome is the [18F]-DPA-714 signal intensity in corpus callosum measured by dynamic positron emission tomography (PET)-MRI at 6 months after the last injection, blinded to the randomisation arm, to evaluate the post-traumatic neuro-inflammation.Ethics and disseminationThe TRAUMACELL trial has been approved by an independent ethics committee (CPP SUD EST II) and French Medicines Agency (2023-504415-33-00) for all study centres. Participant recruitment will be starting in September 2024. Results will be published in international peer-reviewed medical journals.Trial registration numberNCT06146062, first posted 24 November 2023Protocol version identifierTRAUMACELL−V.2.0_20240102</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2024-091441</identifier><identifier>PMID: 39740941</identifier><language>eng</language><publisher>England: British Medical Journal Publishing Group</publisher><subject>Adolescent ; Adult ; Adult intensive & critical care ; Anesthesia ; Angiogenesis ; Biomarkers ; Bone marrow ; Brain damage ; Brain Injuries ; Brain Injuries, Traumatic - therapy ; Clinical Trial ; Clinical Trials, Phase III as Topic ; Cytokines ; Double-Blind Method ; Female ; Humans ; Immunomodulation ; Intensive care ; Male ; Mesenchymal Stem Cell Transplantation - methods ; Mesenchymal Stem Cells ; Middle Aged ; Multicenter Studies as Topic ; Neurogenesis ; Neuroinflammatory Diseases - etiology ; Neuroinflammatory Diseases - therapy ; Neuroradiology ; NUCLEAR MEDICINE ; Patients ; Pharmacokinetics ; Prospective Studies ; Randomized Controlled Trials as Topic ; Tomography ; Toxicity ; Traumatic brain injury ; Umbilical cord ; Umbilical Cord - cytology ; Wharton Jelly - cytology ; Young Adult</subject><ispartof>BMJ open, 2024-12, Vol.14 (12), p.e091441</ispartof><rights>Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.</rights><rights>2024 Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . 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><cites>FETCH-LOGICAL-b1681-b82cda069ac4cbc556294c5396894b7f0960918924ab0d49cd196c613909a6af3</cites><orcidid>0000-0002-5006-6249 ; 0000-0002-7334-0132 ; 0000-0002-4888-7769</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/14/12/e091441.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/14/12/e091441.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,864,27923,27924,55349,77431,77457</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39740941$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sigaut, Stéphanie</creatorcontrib><creatorcontrib>Tardivon, Coralie</creatorcontrib><creatorcontrib>Jacquens, Alice</creatorcontrib><creatorcontrib>Bottlaender, Michel</creatorcontrib><creatorcontrib>Gervais, Philippe</creatorcontrib><creatorcontrib>Habert, Marie-Odile</creatorcontrib><creatorcontrib>Monsel, Antoine</creatorcontrib><creatorcontrib>Roquilly, Antoine</creatorcontrib><creatorcontrib>Boutonnet, Mathieu</creatorcontrib><creatorcontrib>Galanaud, Damien</creatorcontrib><creatorcontrib>Cras, Audrey</creatorcontrib><creatorcontrib>Boucher-Pillet, Hélène</creatorcontrib><creatorcontrib>Florence, Aline-Marie</creatorcontrib><creatorcontrib>Cavalier, Ines</creatorcontrib><creatorcontrib>Menasche, Philippe</creatorcontrib><creatorcontrib>Degos, Vincent</creatorcontrib><creatorcontrib>Couffignal, Camille</creatorcontrib><title>Effects of intravascular administration of mesenchymal stromal cells derived from Wharton’s Jelly of the umbilical cord on systemic immunomodulation and neuroinflammation after traumatic brain injury (TRAUMACELL): study protocol for a multicentre randomised controlled trial</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><addtitle>BMJ Open</addtitle><description>IntroductionTraumatic brain injury (TBI) is one of the leading causes of death and disability worldwide. Treatments for TBI patients are limited and none has been shown to provide prolonged and long-term neuroprotective or neurorestorative effects. A growing body of evidence suggests a link between TBI-induced neuro-inflammation and neurodegenerative post-traumatic disorders. Consequently, new therapies triggering immunomodulation and promoting neurological recovery are the subject of major research efforts. We hypothesise that repeated intravenous treatment with mesenchymal stromal cells derived from Wharton’s Jelly of the umbilical cord-derived mesenchymal stromal cells ((WJ-UC-MSC) may be associated with a significant decrease of post-TBI neuroinflammation and improvement of neurological status.Methods and analysisThe TRAUMACELL trial is a prospective, national multicentre, phase III, superiority, double-arm comparative randomised (1:1) double-blinded clinical trial. Among patients aged between 18–50, with a severe TBI defined by a Glasgow score less than 12 (within the first 48 hours) with brain traumatic lesion on CT Scan and needing intracranial pressure monitoring, with no other significant organ trauma (abbreviated injury scale<2) and unresponsive to verbal commands after 5 days of sedation discontinuation, 68 will be randomly allocated to receive either WJ-UC-MSC solution or placebo, with three intravenous injections 1 week apart. The primary outcome is the [18F]-DPA-714 signal intensity in corpus callosum measured by dynamic positron emission tomography (PET)-MRI at 6 months after the last injection, blinded to the randomisation arm, to evaluate the post-traumatic neuro-inflammation.Ethics and disseminationThe TRAUMACELL trial has been approved by an independent ethics committee (CPP SUD EST II) and French Medicines Agency (2023-504415-33-00) for all study centres. Participant recruitment will be starting in September 2024. Results will be published in international peer-reviewed medical journals.Trial registration numberNCT06146062, first posted 24 November 2023Protocol version identifierTRAUMACELL−V.2.0_20240102</description><subject>Adolescent</subject><subject>Adult</subject><subject>Adult intensive & critical care</subject><subject>Anesthesia</subject><subject>Angiogenesis</subject><subject>Biomarkers</subject><subject>Bone marrow</subject><subject>Brain damage</subject><subject>Brain Injuries</subject><subject>Brain Injuries, Traumatic - therapy</subject><subject>Clinical Trial</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Cytokines</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Immunomodulation</subject><subject>Intensive care</subject><subject>Male</subject><subject>Mesenchymal Stem Cell Transplantation - methods</subject><subject>Mesenchymal Stem Cells</subject><subject>Middle Aged</subject><subject>Multicenter Studies as Topic</subject><subject>Neurogenesis</subject><subject>Neuroinflammatory Diseases - 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Academic</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sigaut, Stéphanie</au><au>Tardivon, Coralie</au><au>Jacquens, Alice</au><au>Bottlaender, Michel</au><au>Gervais, Philippe</au><au>Habert, Marie-Odile</au><au>Monsel, Antoine</au><au>Roquilly, Antoine</au><au>Boutonnet, Mathieu</au><au>Galanaud, Damien</au><au>Cras, Audrey</au><au>Boucher-Pillet, Hélène</au><au>Florence, Aline-Marie</au><au>Cavalier, Ines</au><au>Menasche, Philippe</au><au>Degos, Vincent</au><au>Couffignal, Camille</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of intravascular administration of mesenchymal stromal cells derived from Wharton’s Jelly of the umbilical cord on systemic immunomodulation and neuroinflammation after traumatic brain injury (TRAUMACELL): study protocol for a multicentre randomised controlled trial</atitle><jtitle>BMJ open</jtitle><stitle>BMJ Open</stitle><addtitle>BMJ Open</addtitle><date>2024-12-31</date><risdate>2024</risdate><volume>14</volume><issue>12</issue><spage>e091441</spage><pages>e091441-</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionTraumatic brain injury (TBI) is one of the leading causes of death and disability worldwide. Treatments for TBI patients are limited and none has been shown to provide prolonged and long-term neuroprotective or neurorestorative effects. A growing body of evidence suggests a link between TBI-induced neuro-inflammation and neurodegenerative post-traumatic disorders. Consequently, new therapies triggering immunomodulation and promoting neurological recovery are the subject of major research efforts. We hypothesise that repeated intravenous treatment with mesenchymal stromal cells derived from Wharton’s Jelly of the umbilical cord-derived mesenchymal stromal cells ((WJ-UC-MSC) may be associated with a significant decrease of post-TBI neuroinflammation and improvement of neurological status.Methods and analysisThe TRAUMACELL trial is a prospective, national multicentre, phase III, superiority, double-arm comparative randomised (1:1) double-blinded clinical trial. Among patients aged between 18–50, with a severe TBI defined by a Glasgow score less than 12 (within the first 48 hours) with brain traumatic lesion on CT Scan and needing intracranial pressure monitoring, with no other significant organ trauma (abbreviated injury scale<2) and unresponsive to verbal commands after 5 days of sedation discontinuation, 68 will be randomly allocated to receive either WJ-UC-MSC solution or placebo, with three intravenous injections 1 week apart. The primary outcome is the [18F]-DPA-714 signal intensity in corpus callosum measured by dynamic positron emission tomography (PET)-MRI at 6 months after the last injection, blinded to the randomisation arm, to evaluate the post-traumatic neuro-inflammation.Ethics and disseminationThe TRAUMACELL trial has been approved by an independent ethics committee (CPP SUD EST II) and French Medicines Agency (2023-504415-33-00) for all study centres. Participant recruitment will be starting in September 2024. Results will be published in international peer-reviewed medical journals.Trial registration numberNCT06146062, first posted 24 November 2023Protocol version identifierTRAUMACELL−V.2.0_20240102</abstract><cop>England</cop><pub>British Medical Journal Publishing Group</pub><pmid>39740941</pmid><doi>10.1136/bmjopen-2024-091441</doi><orcidid>https://orcid.org/0000-0002-5006-6249</orcidid><orcidid>https://orcid.org/0000-0002-7334-0132</orcidid><orcidid>https://orcid.org/0000-0002-4888-7769</orcidid><oa>free_for_read</oa></addata></record> |
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| language | eng |
| recordid | cdi_proquest_miscellaneous_3150523222 |
| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; PubMed Central Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Adolescent Adult Adult intensive & critical care Anesthesia Angiogenesis Biomarkers Bone marrow Brain damage Brain Injuries Brain Injuries, Traumatic - therapy Clinical Trial Clinical Trials, Phase III as Topic Cytokines Double-Blind Method Female Humans Immunomodulation Intensive care Male Mesenchymal Stem Cell Transplantation - methods Mesenchymal Stem Cells Middle Aged Multicenter Studies as Topic Neurogenesis Neuroinflammatory Diseases - etiology Neuroinflammatory Diseases - therapy Neuroradiology NUCLEAR MEDICINE Patients Pharmacokinetics Prospective Studies Randomized Controlled Trials as Topic Tomography Toxicity Traumatic brain injury Umbilical cord Umbilical Cord - cytology Wharton Jelly - cytology Young Adult |
| title | Effects of intravascular administration of mesenchymal stromal cells derived from Wharton’s Jelly of the umbilical cord on systemic immunomodulation and neuroinflammation after traumatic brain injury (TRAUMACELL): study protocol for a multicentre randomised controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-09T09%3A37%3A47IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effects%20of%20intravascular%20administration%20of%20mesenchymal%20stromal%20cells%20derived%20from%20Wharton%E2%80%99s%20Jelly%20of%20the%20umbilical%20cord%20on%20systemic%20immunomodulation%20and%20neuroinflammation%20after%20traumatic%20brain%20injury%20(TRAUMACELL):%20study%20protocol%20for%20a%20multicentre%20randomised%20controlled%20trial&rft.jtitle=BMJ%20open&rft.au=Sigaut,%20St%C3%A9phanie&rft.date=2024-12-31&rft.volume=14&rft.issue=12&rft.spage=e091441&rft.pages=e091441-&rft.issn=2044-6055&rft.eissn=2044-6055&rft_id=info:doi/10.1136/bmjopen-2024-091441&rft_dat=%3Cproquest_cross%3E3150523222%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3150330916&rft_id=info:pmid/39740941&rfr_iscdi=true |