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Evaluation of bone marrow-derived cell-based therapies in the hindlimb ischaemia model: a protocol for a systematic review and meta-analysis

BMJ open science, 2021-12, Vol.5 (1), p.e100209-e100209 [Peer Reviewed Journal]

Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. ;2021 Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. 2021 ;ISSN: 2398-8703 ;EISSN: 2398-8703 ;DOI: 10.1136/bmjos-2021-100209 ;PMID: 35047706

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  • Title:
    Evaluation of bone marrow-derived cell-based therapies in the hindlimb ischaemia model: a protocol for a systematic review and meta-analysis
  • Author: van Rhijn-Brouwer, Femke Christina Ching Chuan ; Vernooij, Robin Wilhelmus Maria ; Wever, Kimberley ; Schilt, Iris ; Fledderus, Joos Ougust ; Verhaar, Maria Christina ; Gremmels, Hendrik
  • Subjects: angiogenesis ; Bias ; Bone marrow ; cardiovascular disease ; cell therapy ; Clinical trials ; Good Manufacturing Practice ; hindlimb ischemia ; Intervention ; Ischemia ; Laboratory animals ; Lasers ; Meta-analysis ; peripheral artery disease ; Protocol ; Stem cells ; Systematic review
  • Is Part Of: BMJ open science, 2021-12, Vol.5 (1), p.e100209-e100209
  • Description: ObjectiveBone marrow(BM)-derived cell-based therapies for critical limb ischamia showed less clinical benefit than expected. While this might be due to patient-specific factors, it remains possible that important details were lost in the bench-to-clinic translation. The hindlimb ischaemia model is the golden standard to evaluate cell-based therapies aimed at promoting neovascularisation. To inform future trial design and identify potential knowledge gaps, we propose a systematic review and meta-analysis of preclinical evidence to assess the efficacy of BM-derived cell administration in restoring relative perfusion in the hind limb model and identify determinants of therapeutic efficacy.Search strategyPubMed and EMBASE were searched for prospective studies in which the hindlimb ischaemia model was used to assess BM-derived therapies.Screening and annotationStudies with an outcome measure related to relative perfusion of the hindlimb will be included. Study characteristics which include model-related factors as well as details on BM therapy will be extracted.Data management and reportingFor the primary analysis, a random effects model will be constructed using the mean difference calculated from the maximum relative perfusion for each study arm in each study. A separate model will be constructed using the relative perfusion at the latest time point in each study. We will also assess the risk of bias using the SYRCLE tool for internal validity. Subgroup analysis will be performed on animal characteristics, administration route, dose and cell characteristics such as the cell donor.PROSPERO registration numberThis protocol has been registered at PROSPERO (CRD2021226592).
  • Publisher: England: BMJ Publishing Group Ltd
  • Language: English
  • Identifier: ISSN: 2398-8703
    EISSN: 2398-8703
    DOI: 10.1136/bmjos-2021-100209
    PMID: 35047706
  • Source: BMJ Open Access Journals
    Open Access: PubMed Central
    AUTh Library subscriptions: ProQuest Central
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