Derivation of GMP Raw Materials for Use in Regenerative Medicine: hESC-based Therapies, Progress Toward Clinical Application

Hewitt, Zoë; Amps, Katherine; Moore, H. D. M.

doi:10.1038/sj.clpt.6100321

Cited by 28 publications

(15 citation statements)

References 16 publications

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“…Remarkably, approval from several regulatory agencies such as Human Fertility and Embryology Authority (HFEA), Human Tissue Authority (HTA) and Medicines and Healthcare products Regulatory Agency (MHRA) is essential for the derivation process of hESCs and their use in cell based therapies in UK (9). …”

mentioning

confidence: 99%

Human embryonic stem cells and good manufacturing practice: Report of a 1- day workshop held at Stem Cell Biology Research Center, Yazd, 27th April 2017

Akyash

Sadeghian‐Nodoushan

Tahajjodi

et al. 2017

IJRM

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This report explains briefly the minutes of a 1-day workshop entitled; “human embryonic stem cells (hESCs) and good manufacturing practice (GMP)” held by Stem Cell Biology Research Center based in Yazd Reproductive Sciences Institute at Shahid Sadoughi University of Medical Sciences, Yazd, Iran on 27th April 2017. In this workshop, in addition to the practical sessions, Prof. Harry D. Moore from Centre for Stem Cell Biology, University of Sheffield, UK presented the challenges and the importance of the biotechnology of clinical-grade human embryonic stem cells from first derivation to robust defined culture for therapeutic applications.

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mentioning

confidence: 99%

Human embryonic stem cells and good manufacturing practice: Report of a 1- day workshop held at Stem Cell Biology Research Center, Yazd, 27th April 2017

Akyash

Sadeghian‐Nodoushan

Tahajjodi

et al. 2017

IJRM

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“…The hESC can now be grown successfully on porous-membranes (Kim et al 2007) and on animal-free, human foreskin fibroblast feeder cultures (Meng et al 2008). Advances are being made in the use of xeno-free hESC culture components (McDevitt and Palecek 2008) and largescale culture under GMP guidelines (Hewitt et al 2007;McDevitt and Palecek 2008).…”

Section: Culture Conditionsmentioning

confidence: 98%

“…A roadmap for the systematic bioprocess production of stem cells has been extensively described (Kirouac and Zandstra 2008). Any genetic change or modification to a donor human cell, that is reprogrammed to become a pluripotent stem cell cultured ex vivo for a long period of time to generate tissue-specific lineages, would have to undergo many analyses (Maitra et al 2005;Hanson and Caisander 2005;Imreh et al 2006;Hewitt et al 2007). Two recent analyses of various hESC lines using whole-genome arrays showed that many of the cell lines exhibit an amplification of 2.5-4.6 Mb at 20q11.21, encompassing 23 genes in common, after long-term cell culture (Lefort et al 2008;Spits et al 2008).…”

Section: Culture Conditionsmentioning

confidence: 99%

Strategies for future histocompatible stem cell therapy

Nehlin

Barington

2009

Biogerontology

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Stem cell therapy based on the safe and unlimited self-renewal of human pluripotent stem cells is envisioned for future use in tissue or organ replacement after injury or disease. A gradual decline of regenerative capacity has been documented among the adult stem cell population in some body organs during the aging process. Recent progress in human somatic cell nuclear transfer and inducible pluripotent stem cell technologies has shown that patient-derived nuclei or somatic cells can be reprogrammed in vitro to become pluripotent stem cells, from which the three germ layer lineages can be generated, genetically identical to the recipient. Once differentiation protocols and culture conditions can be defined and optimized, patient-histocompatible pluripotent stem cells could be directed towards virtually every cell type in the human body. Harnessing this capability to enrich for given cells within a developmental lineage, would facilitate the transplantation of organ/tissue-specific adult stem cells or terminally differentiated somatic cells to improve the function of diseased organs or tissues in an individual. Here, we present an overview of various experimental cell therapy technologies based on the use of patient-histocompatible stem cells, the pending issues needed to be dealt with before clinical trials can be initiated, evidence for the loss and/or aging of the stem cell pool and some of the possible uses of human pluripotent stem cell-derivatives aimed at curing disease and improving health.

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“…Amit et al [23] first reported the successful use of knockout serum for ESC culture as a replacement for bovine serum, although this semi-defined serum replacement contains xenogenic or undefined substances such as bovine serum albumin [24]. Subsequently, a culture medium containing human-originated recombinant proteins was developed (X-VIVO 10 medium).…”

Section: Application Of 2d Niche Systems To Stem Cell Self-renewal Mamentioning

confidence: 99%

Stem cell maintenance in a different niche

Lim

Ahn

Lee

2013

Clin Exp Reprod Med

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To overcome the difficulty of controlling stem cell fate and function in applications to regenerative medicine, a number of alternative approaches have been made. Recent reports demonstrate that a non-cellular niche modulating the biophysical microenvironment with chemical factors can support stem cell self-renewal. In our previous studies, early establishment was executed to optimize biophysical factors and it was subsequently found that the microgeometry of the extracellular matrix made huge differences in stem cell behavior and phenotype. We review here a three-dimensional, non-cellular niche designed to support stem cell self-renewal. The characteristics of stem cells under the designed system are further discussed.

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Derivation of GMP Raw Materials for Use in Regenerative Medicine: hESC-based Therapies, Progress Toward Clinical Application

Cited by 28 publications

References 16 publications

Human embryonic stem cells and good manufacturing practice: Report of a 1- day workshop held at Stem Cell Biology Research Center, Yazd, 27th April 2017

Human embryonic stem cells and good manufacturing practice: Report of a 1- day workshop held at Stem Cell Biology Research Center, Yazd, 27th April 2017

Strategies for future histocompatible stem cell therapy

Stem cell maintenance in a different niche

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