A Decade of Cell Therapy Clinical Trials (2000–2010)

Culme-Seymour, Emily; Davie, Natasha L.; Brindley, David; Edwards-Parton, S; Mason, Chris

doi:10.2217/rme.12.45

Cited by 61 publications

(34 citation statements)

References 16 publications

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“…Evaluations of registered trial data have recently been used to shed light on national clinical trial portfolios 29,30 and specific research areas. [31][32][33][34] This type of evaluation has several strengths: all trials should be registered, even if their final results are never published; registered records contain information that is complementary to that in any published articles on the trials; 35 databases of registered trials can provide insight into currently ongoing R&D; and their standardized and searchable format makes databases of registered trials suitable for aggregate analysis. 36 For the purpose of obtaining a comprehensive global picture of all ongoing clinical trials, the ICTRP is an unmatched resource of information since it provides access to data from all of the major clinical trial registries around the world that meet the relevant standards of WHO's registry criteria.…”

Section: Discussionmentioning

confidence: 99%

Use of data from registered clinical trials to identify gaps in health research and development

Viergever

Terry

Karam

2013

Bull. World Health Organ.

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Section: Discussionmentioning

confidence: 99%

Use of data from registered clinical trials to identify gaps in health research and development

Viergever

Terry

Karam

2013

Bull. World Health Organ.

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“…Mesenchymal stem cells (MSCs), a fibroblast-like subpopulation found in BM and other tissues, have been shown to differentiate into a variety of adult tissues and, after systemic administration, have been shown to be safe regarding tumorigenesis and other adverse side effects (Jung et al 2012). Indeed, MSC regenerative therapies are being currently tested in a variety of diseases including immune modulation, bone and cartilage repair, cardiac regeneration, and wound repair (Sensebé et al 2010;Culme-Seymour et al 2012). It is also noteworthy that such adult tissue -derived stem cell regenerative cell therapies are advancing rapidly in veterinary medicine where there is less regulatory stringency.…”

Section: Mesenchymal Stem Cell Autologous and Allogeneic Cell Therapiesmentioning

confidence: 99%

“…In summary, although a recently published comprehensive review on ongoing cell therapy trials ends with the optimistic note that "overall, these data are highly encouraging for the emerging cell therapy industry, given the early stage of the technology platform in its life cycle, total number of trials, the spread of clinical trial phases and the range of medical indications" (Culme-Seymour et al 2012), there remains significant challenges before this becomes a routine approach to discovering and developing new medicines.…”

Section: Mesenchymal Stem Cell Autologous and Allogeneic Cell Therapiesmentioning

confidence: 99%

Regenerative Medicine: Transforming the Drug Discovery and Development Paradigm

Karathanasis¹

2014

Cold Spring Harbor Perspectives in Medicine

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Despite the explosion of knowledge in basic biological processes controlling tissue regeneration and the growing interest in repairing/replacing diseased tissues and organs through various approaches (e.g., small and large molecule therapeutics, stem cell injection, tissue engineering), the pharmaceutical industry ( pharma) has been reluctant to fully adopt these technologies into the traditional drug discovery and research and development (R&D) process. In this article, I discuss knowledge-base gaps and other possible factors that may delay full incorporation of these innovations in pharma R&D. I hope that this discussion will illuminate key issues that currently limit synergistic relationships between pharma and academic institutions and may even stimulate initiation of such collaborative research.B reakthroughs in stem cell biology and the clinical evaluation of regenerative therapeutics offer an unprecedented opportunity to transform traditional pharma research and development (R&D) and revolutionize future medical practice. Capitalizing on these opportunities will require a significant transformation in the pharma R&D model, including a shift in the way pharma and academic institutions interact.Although scientific breakthroughs are driven mostly by academic institutions, conversion of novel biologic insights into successful medical products is dependent on the drug development and distribution infrastructure available in traditional pharma. In this context, successful, purpose-driven innovation at the academia -pharma interface necessitates mutual understanding of the several factors including: general philosophy, long-term vision, operational and cultural paradigms, and key drivers and stressors across both of these enterprises.To describe how emerging technologies in regenerative medicine could transform pharma R&D and revitalize this entire business sector, I will first outline the current pharma R&D business environment and the manner in which this environment is creating the need for change in the prevailing business model.It has been argued that the current pharmaceutical business model is not sustainable because of the productivity crisis in pharma R&D (Pammolli et al. 2011). Many factors are responsible including escalating R&D costs, increased pressures for improved performance drugs, increased payer pressures, excessive regulatory stringency, increased focus on high-risk research involving complex therapeutic targets, and an over-reliance on "molecular reductionEditors:

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“…1 Based on the plasticity and migratory capacity of cells, cell-based therapeutics offer unique possibilities in regenerative medicine, cancer treatment and metabolic diseases. [2][3][4][5] For these applications, the ability of cells to repair damaged tissue, act as drug carriers or modulate or enhance natural cellular processes is used as a treatment strategy. Crucial issues for guaranteeing safe and effective use of cell transplants are in determining the most optimal cell type, the route, dose, accuracy and timing of administration, and the persistence and functionality of the transplanted cells.…”

Section: Introductionmentioning

confidence: 99%

Nanoparticles and clinically applicable cell tracking

Bernsen

Guenoun

Tiel

et al. 2015

BJR

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In vivo cell tracking has emerged as a much sought after tool for design and monitoring of cell-based treatment strategies. Various techniques are available for pre-clinical animal studies, from which much has been learned and still can be learned. However, there is also a need for clinically translatable techniques. Central to in vivo cell imaging is labelling of cells with agents that can give rise to signals in vivo, that can be detected and measured non-invasively. The current imaging technology of choice for clinical translation is MRI in combination with labelling of cells with magnetic agents. The main challenge encountered during the cell labelling procedure is to efficiently incorporate the label into the cell, such that the labelled cells can be imaged at high sensitivity for prolonged periods of time, without the labelling process affecting the functionality of the cells. In this respect, nanoparticles offer attractive features since their structure and chemical properties can be modified to facilitate cellular incorporation and because they can carry a high payload of the relevant label into cells. While these technologies have already been applied in clinical trials and have increased the understanding of cell-based therapy mechanism, many challenges are still faced.

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A Decade of Cell Therapy Clinical Trials (2000–2010)

Cited by 61 publications

References 16 publications

Use of data from registered clinical trials to identify gaps in health research and development

Use of data from registered clinical trials to identify gaps in health research and development

Regenerative Medicine: Transforming the Drug Discovery and Development Paradigm

Nanoparticles and clinically applicable cell tracking

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