Regulatory Insight into the European Human Pluripotent Stem Cell Registry

Kurtz, Armin; Stacey, Glyn; Kidane, Luam; Seriola, Anna; Stachelscheid, Harald; Veiga, Anna

doi:10.1089/scd.2014.0319

Cited by 8 publications

(6 citation statements)

References 19 publications

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“…In addition, the regulatory landscape was and still is characterized by diverse ethical conceptions on hPSC derivation and usage, which continuously requires transparency about the cell's origins, compliance with ethical standards and information about availability of the cells to researchers ( 13 ). The registry supports harmonizing the standards for obtaining informed consent for tissue donation and use, for example by codifying ethics information.…”

Section: Discussionmentioning

confidence: 99%

hPSCreg—the human pluripotent stem cell registry

et al. 2015

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The human pluripotent stem cell registry (hPSCreg), accessible at http://hpscreg.eu, is a public registry and data portal for human embryonic and induced pluripotent stem cell lines (hESC and hiPSC). Since their first isolation the number of hESC lines has steadily increased to over 3000 and new iPSC lines are generated in a rapidly growing number of laboratories as a result of their potentially broad applicability in biomedicine and drug testing. Many of these lines are deposited in stem cell banks, which are globally established to store tens of thousands of lines from healthy and diseased donors. The Registry provides comprehensive and standardized biological and legal information as well as tools to search and compare information from multiple hPSC sources and hence addresses a translational research need. To facilitate unambiguous identification over different resources, hPSCreg automatically creates a unique standardized name for each cell line registered. In addition to biological information, hPSCreg stores extensive data about ethical standards regarding cell sourcing and conditions for application and privacy protection. hPSCreg is the first global registry that holds both, manually validated scientific and ethical information on hPSC lines, and provides access by means of a user-friendly, mobile-ready web application.

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Section: Discussionmentioning

confidence: 99%

hPSCreg—the human pluripotent stem cell registry

et al. 2015

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“…Current technologies for pluripotent stem cell expansion hardly fulfil the demands of regulatory boards (Kurtz et al, 2014) and the needs of clinical use (Kamao et al, 2014), as they are associated with low cost-efficiency (Jenkins & Farid, 2015), lack stringent quality control, or do not meet good manufacturing practices (GMP) standards (Elseberg, Salzig, & Czermak, 2015). Therefore, the development of a standardized, scalable method for pluripotent stem cell expansion that is cost-effective and compatible with automation is of great interest.…”

mentioning

confidence: 99%

Scalable stirred suspension culture for the generation of billions of human induced pluripotent stem cells using single‐use bioreactors

Kwok

Ueda

Kadari

et al. 2017

J Tissue Eng Regen Med

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The production of human induced pluripotent stem cells (hiPSCs) in quantities that are relevant for cell-based therapies and cell-loaded implants through standard adherent culture is hardly achievable and lacks process scalability. A promising approach to overcoming these hurdles is the culture of hiPSCs in suspension. In this study, stirred suspension culture vessels were investigated for their suitability in the expansion of two hiPSC lines inoculated as a single cell suspension, with a free scalability between volumes of 50 and 2400 ml. The simple and robust two-step process reported here first generates hiPSC aggregates of 324 ± 71 μm diameter in 7 days in 125 ml spinner flasks (100 ml volume). These are subsequently dissociated into a single cell suspension for inoculation in 3000 ml bioreactors (1000 ml volume), finally yielding hiPSC aggregates of 198 ± 58 μm after 7 additional days. In both spinner flasks and bioreactors, hiPSCs can be cultured as aggregates for more than 40 days in suspension, maintain an undifferentiated state as confirmed by the expression of pluripotency markers TRA-1-60, TRA-1-81, SSEA-4, OCT4, and SOX2, can differentiate into cells of all three germ layers, and can be directed to differentiate into specific lineages such as cardiomyocytes. Up to a 16-fold increase in hiPSC quantity at the 100 ml volume was achieved, corresponding to a fold increase per day of 2.28; at the 1000 ml scale, an additional 10-fold increase was achieved. Taken together, 16 × 10 6 hiPSCs were expanded into 2 × 10 9 hiPSCs in 14 days for a fold increase per day of 8.93. This quantity of hiPSCs readily meets the requirements of cell-based therapies and brings their clinical potential closer to fruition.

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“…In recent years, substantial developments in stem cell technology in terms of reprogramming efficiency and enhancing their clinical applicability have prompted scientist to utilize pluripotent stem cells (PSCs), not only to regenerate, but also to model the human heart for basic research purposes. Furthermore, some countries have tentatively started to loosen their tight regulations, especially on hESCs; a step that coincided with the establishment of stem-cell registries in the US and Europe [96][97][98]. This has led to several initiatives on stem cell therapy for many disease conditions, including CVDs [99].…”

Section: Embryonic Stem Cells Versus Induced Pluripotent Stem Cellsmentioning

confidence: 99%

Stem Cells in Cardiovascular Medicine: Historical Overview and Future Prospects

Samak

Hinkel

2019

Cells

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Cardiovascular diseases remain the leading cause of death in the developed world, accounting for more than 30% of all deaths. In a large proportion of these patients, acute myocardial infarction is usually the first manifestation, which might further progress to heart failure. In addition, the human heart displays a low regenerative capacity, leading to a loss of cardiomyocytes and persistent tissue scaring, which entails a morbid pathologic sequela. Novel therapeutic approaches are urgently needed. Stem cells, such as induced pluripotent stem cells or embryonic stem cells, exhibit great potential for cell-replacement therapy and an excellent tool for disease modeling, as well as pharmaceutical screening of novel drugs and their cardiac side effects. This review article covers not only the origin of stem cells but tries to summarize their translational potential, as well as potential risks and clinical translation.

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Regulatory Insight into the European Human Pluripotent Stem Cell Registry

Cited by 8 publications

References 19 publications

hPSCreg—the human pluripotent stem cell registry

hPSCreg—the human pluripotent stem cell registry

Scalable stirred suspension culture for the generation of billions of human induced pluripotent stem cells using single‐use bioreactors

Stem Cells in Cardiovascular Medicine: Historical Overview and Future Prospects

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