Safety of Cell Therapy with Mesenchymal Stromal Cells (SafeCell): A Systematic Review and Meta-Analysis of Clinical Trials
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{"title"=>"Safety of Cell Therapy with Mesenchymal Stromal Cells (SafeCell): A Systematic Review and Meta-Analysis of Clinical Trials", "type"=>"generic", "authors"=>[{"first_name"=>"Manoj M.", "last_name"=>"Lalu", "scopus_author_id"=>"7801545674"}, {"first_name"=>"Lauralyn", "last_name"=>"McIntyre", "scopus_author_id"=>"7101992439"}, {"first_name"=>"Christina", "last_name"=>"Pugliese", "scopus_author_id"=>"56654296900"}, {"first_name"=>"Dean", "last_name"=>"Fergusson", "scopus_author_id"=>"7102364909"}, {"first_name"=>"Brent W.", "last_name"=>"Winston", "scopus_author_id"=>"7003331349"}, {"first_name"=>"John C.", "last_name"=>"Marshall", "scopus_author_id"=>"18536499900"}, {"first_name"=>"John", "last_name"=>"Granton", "scopus_author_id"=>"7004003295"}, {"first_name"=>"Duncan J.", "last_name"=>"Stewart", "scopus_author_id"=>"55613413700"}], "year"=>2012, "source"=>"PLoS ONE", "identifiers"=>{"scopus"=>"2-s2.0-84868091993", "sgr"=>"84868091993", "issn"=>"19326203", "doi"=>"10.1371/journal.pone.0047559", "pmid"=>"23133515", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)", "pui"=>"365952284"}, "id"=>"9f892b88-fc42-3f09-8636-5593a12f2324", "abstract"=>"BACKGROUND: Mesenchymal stromal cells (MSCs, \"adult stem cells\") have been widely used experimentally in a variety of clinical contexts. There is interest in using these cells in critical illness, however, the safety profile of these cells is not well known. We thus conducted a systematic review of clinical trials that examined the use MSCs to evaluate their safety.\\n\\nMETHODS AND FINDINGS: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (to June 2011), were searched. Prospective clinical trials that used intravascular delivery of MSCs (intravenously or intra-arterially) in adult populations or mixed adult and pediatric populations were identified. Studies using differentiated MSCs or additional cell types were excluded. The primary outcome adverse events were grouped according to immediate events (acute infusional toxicity, fever), organ system complications, infection, and longer term adverse events (death, malignancy). 2347 citations were reviewed and 36 studies met inclusion criteria. A total of 1012 participants with clinical conditions of ischemic stroke, Crohn's disease, cardiomyopathy, myocardial infarction, graft versus host disease, and healthy volunteers were included. Eight studies were randomized control trials (RCTs) and enrolled 321 participants. Meta-analysis of the RCTs did not detect an association between acute infusional toxicity, organ system complications, infection, death or malignancy. There was a significant association between MSCs and transient fever.\\n\\nCONCLUSIONS: Based on the current clinical trials, MSC therapy appears safe. However, further larger scale controlled clinical trials with rigorous reporting of adverse events are required to further define the safety profile of MSCs.", "link"=>"http://www.mendeley.com/research/safety-cell-therapy-mesenchymal-stromal-cells-safecell-systematic-review-metaanalysis-clinical-trial-6", "reader_count"=>284, "reader_count_by_academic_status"=>{"Unspecified"=>7, "Professor > Associate Professor"=>16, "Researcher"=>64, "Student > Doctoral Student"=>17, "Student > Ph. D. Student"=>64, "Student > Postgraduate"=>12, "Student > Master"=>41, "Other"=>22, "Student > Bachelor"=>25, "Lecturer"=>4, "Lecturer > Senior Lecturer"=>2, "Professor"=>9}, "reader_count_by_user_role"=>{"Unspecified"=>7, "Professor > Associate Professor"=>16, "Researcher"=>64, "Student > Doctoral Student"=>17, "Student > Ph. D. 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  • {"files"=>["https://ndownloader.figshare.com/files/296474", "https://ndownloader.figshare.com/files/296553", "https://ndownloader.figshare.com/files/296618"], "description"=>"<div><h3>Background</h3><p>Mesenchymal stromal cells (MSCs, “adult stem cells”) have been widely used experimentally in a variety of clinical contexts. There is interest in using these cells in critical illness, however, the safety profile of these cells is not well known. We thus conducted a systematic review of clinical trials that examined the use MSCs to evaluate their safety.</p> <h3>Methods and Findings</h3><p>MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (to June 2011), were searched. Prospective clinical trials that used intravascular delivery of MSCs (intravenously or intra-arterially) in adult populations or mixed adult and pediatric populations were identified. Studies using differentiated MSCs or additional cell types were excluded. The primary outcome adverse events were grouped according to immediate events (acute infusional toxicity, fever), organ system complications, infection, and longer term adverse events (death, malignancy). 2347 citations were reviewed and 36 studies met inclusion criteria. A total of 1012 participants with clinical conditions of ischemic stroke, Crohn's disease, cardiomyopathy, myocardial infarction, graft versus host disease, and healthy volunteers were included. Eight studies were randomized control trials (RCTs) and enrolled 321 participants. Meta-analysis of the RCTs did not detect an association between acute infusional toxicity, organ system complications, infection, death or malignancy. There was a significant association between MSCs and transient fever.</p> <h3>Conclusions</h3><p>Based on the current clinical trials, MSC therapy appears safe. However, further larger scale controlled clinical trials with rigorous reporting of adverse events are required to further define the safety profile of MSCs.</p> </div>", "links"=>[], "tags"=>["mesenchymal", "stromal", "cells", "systematic", "meta-analysis", "trials"], "article_id"=>118408, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.s001", "https://dx.doi.org/10.1371/journal.pone.0047559.s002", "https://dx.doi.org/10.1371/journal.pone.0047559.s003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Safe_ty_of_Cell_Therapy_with_Mesenchymal_Stromal_Cells_SafeCell_A_Systematic_Review_and_Meta_Analysis_of_Clinical_Trials__/118408", "title"=>"Safety of Cell Therapy with Mesenchymal Stromal Cells (SafeCell): A Systematic Review and Meta-Analysis of Clinical Trials", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2012-10-25 02:20:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/552981"], "description"=>"<p>Flow Diagram of Included and Excluded Studies.</p>", "links"=>[], "tags"=>["diagram", "included", "excluded"], "article_id"=>223472, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.g001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_Diagram_of_Included_and_Excluded_Studies_/223472", "title"=>"Flow Diagram of Included and Excluded Studies.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-10-25 00:57:52"}
  • {"files"=>["https://ndownloader.figshare.com/files/553124"], "description"=>"<p>Data are presented as mean (95% confidence interval [CI]) differences in adverse events between control treatment and MSC treatment.</p>", "links"=>[], "tags"=>["intervals", "meta-analysis", "adverse"], "article_id"=>223615, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.g002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Confidence_Intervals_and_Meta_analysis_of_Adverse_Events_/223615", "title"=>"Confidence Intervals and Meta-analysis of Adverse Events.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2012-10-25 01:00:15"}
  • {"files"=>["https://ndownloader.figshare.com/files/553261"], "description"=>"<p>Abbreviations:</p>¥<p> = both follow-up duration and frequency defined a priori for adverse event,</p>+<p> = adverse event not defined a priori,</p>*<p> = clinical endpoint defined a priori,</p>++<p> = only follow-up duration listed for all events a priori, follow-up frequency not listed, AE = adverse event, DMSO = dimethylsulfoxide, FBS = fetal bovine serum, GVHD = graft-versus-host disease.</p>", "links"=>[], "tags"=>["adverse", "events", "trials"], "article_id"=>223750, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.t010"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Descriptions_and_reporting_of_adverse_events_in_clinical_trials_with_no_control_group_/223750", "title"=>"Descriptions and reporting of adverse events in clinical trials with no control group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-25 01:02:30"}
  • {"files"=>["https://ndownloader.figshare.com/files/553302"], "description"=>"<p>Abbreviations:</p><p>− = not reported, CMV = cytomegalovirus, GVHD = graft-versus-host disease,</p>", "links"=>[], "tags"=>["adverse", "events", "non", "randomized", "controlled"], "article_id"=>223797, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.t006"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Frequency_of_adverse_events_in_non_randomized_controlled_trials_/223797", "title"=>"Frequency of adverse events in non randomized controlled trials.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-25 01:03:17"}
  • {"files"=>["https://ndownloader.figshare.com/files/553344"], "description"=>"<p>Abbreviations:</p><p>− = not applicable; AML = acute myelogenous leukemia, CMV = cytomegalovirus, DMSO = dimethylsulfoxide, EBV = Epstein-Barr virus; GVHD = graft-versus-host disease.</p>", "links"=>[], "tags"=>["adverse", "events", "trials"], "article_id"=>223833, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.t007"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Frequency_of_adverse_events_in_clinical_trials_with_no_control_group_/223833", "title"=>"Frequency of adverse events in clinical trials with no control group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-25 01:03:53"}
  • {"files"=>["https://ndownloader.figshare.com/files/553377"], "description"=>"<p>Abbreviations:</p><p>L = low risk of bias, H = high risk of bias, U = unclear risk of bias.</p>", "links"=>[], "tags"=>["randomized"], "article_id"=>223873, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.t004"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Risk_of_bias_assessment_of_randomized_control_trials_/223873", "title"=>"Risk of bias assessment of randomized control trials.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-25 01:04:33"}
  • {"files"=>["https://ndownloader.figshare.com/files/553421"], "description"=>"<p>Abbreviations: AE = adverse event, FBS = fetal bovine serum, GVHD = graft versus host disease, MRI = magnetic resonance imaging.</p>", "links"=>[], "tags"=>["adverse", "events", "randomized", "controlled"], "article_id"=>223914, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.t005"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Frequency_of_adverse_events_in_randomized_controlled_trials_/223914", "title"=>"Frequency of adverse events in randomized controlled trials.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-25 01:05:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/553462"], "description"=>"<p>Abbreviations:</p>−<p> = not applicable, BEL = Belgium, C = control group, GVHD = graft-versus-host disease, H = high dose, IC = intracoronary, IND = India, IRN = Iran, ITL = Italy, IV = peripheral intravenous, IM = intramyocardial, L = low dose, M = middle dose, SD = standard deviation, OV = omental vein, PRC = People's Republic of China, SPA = Spain, SWE = Sweden, T = treatment group, USA = United States of America,</p>+<p> = mean (range),</p>¥<p> = median (range),</p>#<p> = % male only provided for combined dose cohorts.</p>**<p>Control groups received lower doses of MSCs.</p>", "links"=>[], "tags"=>["non", "randomized", "controlled"], "article_id"=>223957, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Characteristics_of_non_randomized_controlled_trials_/223957", "title"=>"Characteristics of non randomized controlled trials.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-25 01:05:57"}
  • {"files"=>["https://ndownloader.figshare.com/files/553498"], "description"=>"<p>Abbreviations:</p><p>− = not applicable, ALS = amyotrophic lateral sclerosis, AUS = Australia, BEL = Belgium, C = control group, CV = central venous, GRC = Greece, GVHD = graft-versus-host disease, IA = intraarterial, ICN = intracranially, IRN = Iran, ISR = Israel, IC = intracoronary, IT = intrathecal, ITL = Italy, IV = peripheral intravenous, JPN = Japan, IM = intramyocardial, L = low dose, M = middle dose, MLD = metachromatic leukodystophy, MS = multiple sclerosis, SD = standard deviation, NL = Netherlands, NR = not reported, PRC = People's Republic of China, SLE = systemic lupus erythematosus, SWE = Sweden, USA = United States of America.</p>*<p> = mean (range),</p>+<p> = range,</p>¥<p> = median (range).</p>", "links"=>[], "tags"=>["trials"], "article_id"=>223993, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.t003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Characteristics_of_clinical_trials_with_no_control_group_/223993", "title"=>"Characteristics of clinical trials with no control group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-25 01:06:33"}
  • {"files"=>["https://ndownloader.figshare.com/files/553533"], "description"=>"<p>Abbreviations:</p><p>− = not reported,</p>*<p> = range, C = control group, CV = central venous, IA = intraarterial, IC = intracoronary, IV = peripheral intravenous, MSA = multiple systems atrophy, SD = standard deviation, PRC = People's Republic of China, RCT = randomized controlled trial, ROK = Republic of Korea, T = treatment group, USA = United States of America,</p>", "links"=>[], "tags"=>["randomized"], "article_id"=>224023, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Characteristics_of_randomized_control_trials_/224023", "title"=>"Characteristics of randomized control trials.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-25 01:07:03"}
  • {"files"=>["https://ndownloader.figshare.com/files/553576"], "description"=>"<p>Abbreviations:</p>+<p> = adverse event not defined a priori,</p>*<p> = clinical endpoint defined a priori,</p>¥<p> = both follow-up duration and frequency defined a priori for adverse event, AE = adverse event, FBS = fetal bovine serum, GVHD = graft-versus-host disease.</p>", "links"=>[], "tags"=>["adverse", "events", "randomized"], "article_id"=>224066, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.t008"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Descriptions_and_reporting_of_adverse_events_in_randomized_control_trials_/224066", "title"=>"Descriptions and reporting of adverse events in randomized control trials.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-25 01:07:46"}
  • {"files"=>["https://ndownloader.figshare.com/files/553613"], "description"=>"<p>Abbreviations:</p><p>− = not reported,</p>+<p> = adverse event not defined a priori,</p>*<p> = clinical endpoint defined a priori,</p>¥<p> = both follow-up duration and frequency defined a priori, AE = adverse event, GVHD = graft-versus-host disease,</p>", "links"=>[], "tags"=>["adverse", "events", "non-randomized", "controlled"], "article_id"=>224103, "categories"=>["Cell Biology", "Developmental Biology", "Pharmacology"], "users"=>["Manoj M. Lalu", "Lauralyn McIntyre", "Christina Pugliese", "Dean Fergusson", "Brent W. Winston", "John C. Marshall", "John Granton", "Duncan J. Stewart"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0047559.t009"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Descriptions_and_reporting_of_adverse_events_in_non_randomized_controlled_trials_/224103", "title"=>"Descriptions and reporting of adverse events in non-randomized controlled trials.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2012-10-25 01:08:23"}

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Relative Metric

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