2015
DOI: 10.1098/rstb.2015.0017
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Cell-based therapy technology classifications and translational challenges

Abstract: Cell therapies offer the promise of treating and altering the course of diseases which cannot be addressed adequately by existing pharmaceuticals. Cell therapies are a diverse group across cell types and therapeutic indications and have been an active area of research for many years but are now strongly emerging through translation and towards successful commercial development and patient access. In this article, we present a description of a classification of cell therapies on the basis of their underlying te… Show more

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Cited by 146 publications
(124 citation statements)
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References 78 publications
(100 reference statements)
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“…We note that current trends in gene-therapy development for β-globinopathies favor editing (for potentially improved biosafety) or universal treatment approaches (for R&D profitability). 24 However, improvements in the efficiency of targeted gene addition have started to address biosafety for integrating vectors, 23 and changes in regulatory requirements, manufacturing cost and reimbursement policies may in the future favor more effective, stratified gene-therapy applications, 25 such as that proposed in this study. Figure 3C (n=3), including raw values of band intensities as measured for the unsaturated original images using ImageJ, and including VCN measurements for the three independent biological replicates.…”
Section: Supplementary Discussionmentioning
confidence: 99%
“…We note that current trends in gene-therapy development for β-globinopathies favor editing (for potentially improved biosafety) or universal treatment approaches (for R&D profitability). 24 However, improvements in the efficiency of targeted gene addition have started to address biosafety for integrating vectors, 23 and changes in regulatory requirements, manufacturing cost and reimbursement policies may in the future favor more effective, stratified gene-therapy applications, 25 such as that proposed in this study. Figure 3C (n=3), including raw values of band intensities as measured for the unsaturated original images using ImageJ, and including VCN measurements for the three independent biological replicates.…”
Section: Supplementary Discussionmentioning
confidence: 99%
“…Indeed, "the reimbursement point is the keystone from which an allowable COGs [Cost of Goods] is determined by subtracting business costs." [34] These developments show the volatile environment in which valuation and reimbursement of RMPs is being debated. We have shown that it has been a growing topic of focused publications between 2015 and 2016, the vast majority of which appear in very disparate avenues or 'spaces' geared to various disciplinary audiences and interested parties.…”
Section: ) Discussionmentioning
confidence: 99%
“…previously unmet clinical conditions and offer a potential solution to the social and economic burden associated with an aging population [1,2]. Human mesenchymal stem/stromal cells (hMSCs) are a promising cell therapy candidate for the treatment of numerous clinical indications [3], however, a transformation is required in the way we isolate, manufacture, characterise and deliver these therapies to ensure they are both efficacious and affordable [2,4].…”
mentioning
confidence: 99%
“…Human mesenchymal stem/stromal cells (hMSCs) are a promising cell therapy candidate for the treatment of numerous clinical indications [3], however, a transformation is required in the way we isolate, manufacture, characterise and deliver these therapies to ensure they are both efficacious and affordable [2,4]. Manufacture of hMSCs requires in vitro expansion to increase the available number of cells to meet clinical demand, however progress is impeded by the lack of advanced methods for the isolation and expansion of cells that are scalable, amenable for automation and closed.…”
mentioning
confidence: 99%