Array-Comparative Genomic Hybridization Characterization of Human Pluripotent Stem Cells

Elliott, Aaron; Elliott, Kristi A. Hohenstein; Kammesheidt, Anja

doi:10.1007/978-1-61779-794-1_17

Cited by 4 publications

(2 citation statements)

References 7 publications

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“…However, hiPSCs face unique challenges as well, including the methods used to produce them and the predicted instability. In this regard, it is well documented that hESCs tend to accumulate mutations over time in culture, including many related to oncogenes [8–15], and the same was predicted to be true for hiPSCs. One type of genomic change – copy number variations (CNVs) – occurs when individual cells have gain or loss of specific genes.…”

Section: The Safety Of Hipsc-based Therapiesmentioning

confidence: 98%

Key Anticipated Regulatory Issues for Clinical Use of Human Induced Pluripotent Stem Cells

Knoepfler

2012

Regen. Med.

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The production of human induced pluripotent stem cells (hiPSCs) has greatly expanded the realm of possible stem cell-based regenerative medicine therapies and has particularly exciting potential for autologous therapies. However, future therapies based on hiPSCs will first have to address not only similar regulatory issues as those facing human embryonic stem cells with the US FDA and international regulatory agencies, but also hiPSCs have raised unique concerns as well. While the first possible clinical use of hiPSCs remains down the road, as a field it would be wise for us to anticipate potential roadblocks and begin formulating solutions. In this article, I discuss the potential regulatory issues facing hiPSCs and propose some potential changes in the direction of the field in response.

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Section: The Safety Of Hipsc-based Therapiesmentioning

confidence: 98%

Key Anticipated Regulatory Issues for Clinical Use of Human Induced Pluripotent Stem Cells

Knoepfler

2012

Regen. Med.

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“…ISCBI guidelines (ISCBI, 2009) for release criteria of banked lines are based on best practices in clinical cytogenetics and recommend G-banding (Bickmore, 2001;Loring et al, 2007) and counting at least 20 metaphase spreads with greater than 95% of the cells confirmed to possess normal karyotype. Recent studies have employed higher resolution analyses, such as comparative genome hybridization (CGH) microarrays, single nucleotide polymorphism (SNP) arrays and whole genome sequencing (Cheng et al, 2012;Elliott et al, 2010Elliott et al, , 2012Gore et al, 2011;Hussein et al, 2011;Maitra et al, 2005;Martins-Taylor et al, 2011). Next-generation sequencing can be used to achieve nucleotide level resolution.…”

Section: B) Karyotypementioning

confidence: 99%

Good Cell Culture Practice for stem cells and stem-cell-derived models

Pamies

Bal‐Price

Simeonov

et al. 2016

ALTEX

138

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SummaryThe first guidance on Good Cell Culture Practice (GCCP) dates back to 2005. This document expands this to include aspects of quality assurance for in vitro cell culture focusing on the increasingly diverse cell types and culture formats used in research, product development, testing and manufacture of biotechnology products and cell-based medicines. It provides a set of basic principles of best practice that can be used in training new personnel, reviewing and improving local procedures, and helping to assure standard practices and conditions for the comparison of data between laboratories and experimentation performed at different times. This includes recommendations for the documentation and reporting of culture conditions. It is intended as guidance to facilitate the generation of reliable data from cell culture systems, and is not intended to conflict with local or higher level legislation or regulatory requirements. It may not be possible to meet all recommendations in this guidance for practical, legal or other reasons. However, when it is necessary to divert from the principles of GCCP, the risk of decreasing the quality of work and the safety of laboratory staff should be addressed and any conclusions or alternative approaches justified. This workshop report is considered a first step toward a revised GCCP 2.0.

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Fetal mesenchymal stromal cells from cryopreserved human chorionic villi: cytogenetic and molecular analysis of genome stability in long-term cultures

Roselli¹,

Lazzati²,

Iseppon³

et al. 2013

Cytotherapy

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Array-Comparative Genomic Hybridization Characterization of Human Pluripotent Stem Cells

Cited by 4 publications

References 7 publications

Key Anticipated Regulatory Issues for Clinical Use of Human Induced Pluripotent Stem Cells

Key Anticipated Regulatory Issues for Clinical Use of Human Induced Pluripotent Stem Cells

Good Cell Culture Practice for stem cells and stem-cell-derived models

Fetal mesenchymal stromal cells from cryopreserved human chorionic villi: cytogenetic and molecular analysis of genome stability in long-term cultures

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