The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments
<p>Abstract</p> <p>Background</p> <p>No treatments are currently available that slow, stop, or reverse disease progression in established multiple sclerosis (MS). The Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) trial tests the safety and feasibility of treatme...
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| Format: | Article |
| Language: | English |
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BMC
2011-03-01
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| Series: | Trials |
| Online Access: | http://www.trialsjournal.com/content/12/1/62 |
| _version_ | 1811283258281820160 |
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| author | Samson Rebecca S Tozer Daniel J Wheeler-Kingshott Claudia AM Webber Daniel J Barber Kelly Richardson Karen He Xiao-Ling Crawley Charles Scott Michael A Patani Rickie Kolappan Madhan Connick Peter Thomas David L Du Ming-Qing Luan Shi L Michell Andrew W Altmann Daniel R Thompson Alan J Miller David H Compston Alastair Chandran Siddharthan |
| author_facet | Samson Rebecca S Tozer Daniel J Wheeler-Kingshott Claudia AM Webber Daniel J Barber Kelly Richardson Karen He Xiao-Ling Crawley Charles Scott Michael A Patani Rickie Kolappan Madhan Connick Peter Thomas David L Du Ming-Qing Luan Shi L Michell Andrew W Altmann Daniel R Thompson Alan J Miller David H Compston Alastair Chandran Siddharthan |
| author_sort | Samson Rebecca S |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>No treatments are currently available that slow, stop, or reverse disease progression in established multiple sclerosis (MS). The Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) trial tests the safety and feasibility of treatment with a candidate cell-based therapy, and will inform the wider challenge of designing early phase clinical trials to evaluate putative neuroprotective therapies in progressive MS. Illustrated by the MSCIMS trial protocol, we describe a novel methodology based on detailed assessment of the anterior visual pathway as a model of wider disease processes - the "sentinel lesion approach".</p> <p>Methods/design</p> <p>MSCIMS is a phase IIA study of autologous mesenchymal stem cells (MSCs) in secondary progressive MS. A pre-test : post-test design is used with healthy controls providing normative data for inter-session variability. Complementary eligibility criteria and outcomes are used to select participants with disease affecting the anterior visual pathway.</p> <p>Results</p> <p>Ten participants with MS and eight healthy controls were recruited between October 2008 and March 2009. Mesenchymal stem cells were successfully isolated, expanded and characterised <it>in vitro </it>for all participants in the treatment arm.</p> <p>Conclusions</p> <p>In addition to determining the safety and feasibility of the intervention and informing design of future studies to address efficacy, MSCIMS adopts a novel strategy for testing neuroprotective agents in MS - the <it>sentinel lesion approach </it>- serving as proof of principle for its future wider applicability.</p> <p>Trial registration</p> <p>ClinicalTrials.gov (<a href="http://www.clinicaltrials.gov/ct2/show/NCT00395200">NCT00395200</a>).</p> |
| first_indexed | 2024-04-13T02:08:13Z |
| format | Article |
| id | doaj.art-6fe16c46d38a404dbd3a9ca26bebff26 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T02:08:13Z |
| publishDate | 2011-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-6fe16c46d38a404dbd3a9ca26bebff262022-12-22T03:07:23ZengBMCTrials1745-62152011-03-011216210.1186/1745-6215-12-62The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessmentsSamson Rebecca STozer Daniel JWheeler-Kingshott Claudia AMWebber Daniel JBarber KellyRichardson KarenHe Xiao-LingCrawley CharlesScott Michael APatani RickieKolappan MadhanConnick PeterThomas David LDu Ming-QingLuan Shi LMichell Andrew WAltmann Daniel RThompson Alan JMiller David HCompston AlastairChandran Siddharthan<p>Abstract</p> <p>Background</p> <p>No treatments are currently available that slow, stop, or reverse disease progression in established multiple sclerosis (MS). The Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) trial tests the safety and feasibility of treatment with a candidate cell-based therapy, and will inform the wider challenge of designing early phase clinical trials to evaluate putative neuroprotective therapies in progressive MS. Illustrated by the MSCIMS trial protocol, we describe a novel methodology based on detailed assessment of the anterior visual pathway as a model of wider disease processes - the "sentinel lesion approach".</p> <p>Methods/design</p> <p>MSCIMS is a phase IIA study of autologous mesenchymal stem cells (MSCs) in secondary progressive MS. A pre-test : post-test design is used with healthy controls providing normative data for inter-session variability. Complementary eligibility criteria and outcomes are used to select participants with disease affecting the anterior visual pathway.</p> <p>Results</p> <p>Ten participants with MS and eight healthy controls were recruited between October 2008 and March 2009. Mesenchymal stem cells were successfully isolated, expanded and characterised <it>in vitro </it>for all participants in the treatment arm.</p> <p>Conclusions</p> <p>In addition to determining the safety and feasibility of the intervention and informing design of future studies to address efficacy, MSCIMS adopts a novel strategy for testing neuroprotective agents in MS - the <it>sentinel lesion approach </it>- serving as proof of principle for its future wider applicability.</p> <p>Trial registration</p> <p>ClinicalTrials.gov (<a href="http://www.clinicaltrials.gov/ct2/show/NCT00395200">NCT00395200</a>).</p>http://www.trialsjournal.com/content/12/1/62 |
| spellingShingle | Samson Rebecca S Tozer Daniel J Wheeler-Kingshott Claudia AM Webber Daniel J Barber Kelly Richardson Karen He Xiao-Ling Crawley Charles Scott Michael A Patani Rickie Kolappan Madhan Connick Peter Thomas David L Du Ming-Qing Luan Shi L Michell Andrew W Altmann Daniel R Thompson Alan J Miller David H Compston Alastair Chandran Siddharthan The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments Trials |
| title | The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments |
| title_full | The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments |
| title_fullStr | The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments |
| title_full_unstemmed | The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments |
| title_short | The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments |
| title_sort | mesenchymal stem cells in multiple sclerosis mscims trial protocol and baseline cohort characteristics an open label pre test post test study with blinded outcome assessments |
| url | http://www.trialsjournal.com/content/12/1/62 |
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