Each pluripotent stem cell line has a physical entity as well as a digital phenotype, but linking the two unambiguously is confounded by poor naming practices and assumed knowledge. Registration gives each line a unique and persistent identifier that links to phenotypic data generated over the lifetime of that line. Registration is a key recommendation of the 2023 ISSCR Standards for the use of human stem cells in research. Here we consider how community adoption of stem cell line registration could facilitate the establishment of integrated digital phenotypes of specific human pluripotent stem cell (hPSC) lines.

The last 5 years have witnessed a significant increase in the number of clinical studies based on human pluripotent stem cells (hPSCs). In parallel, concern is increasing about the proliferation of unregulated stem cell treatments worldwide. Regulated clinical testing is a de facto standard to establish the safety and efficacy of new cell therapies, yet reliable information on clinical studies involving hPSCs is scattered. Our analysis of a multitude of resources found 54 clinical studies involving several types of hPSCs, which are performed in ten countries. While the majority of those studies is based on human embryonic stem cells (hESCs), clinical studies involving human induced pluripotent stem cells increased more strongly in the past 2 years than the number of hESC-based studies. A publicly accessible database was created using the human pluripotent stem cell registry (https://hpscreg.eu) platform, providing a steadily updated comprehensive overview on hPSC-based clinical studies performed worldwide.

The human pluripotent stem cell (hPSC) research landscape is rapidly evolving. To assess possible novel trends in hPSC usage, we analyzed experimental hPSC research published from 2014 to 2016 and compared our data with those of earlier periods. The number of papers describing experimental work involving hPSCs increased further with clear differences in the scientific impact of publications from different countries. Our results confirm the leading position of US-based hPSC research, although to a lesser degree than observed previously. Our data reveal that research into human induced pluripotent stem cells alone surpassed human embryonic stem cell (hESC) research by 2015 and rapidly grew after that. We also report on continuing and even slightly growing research activities in the hESC field as well as on a generally declining rate of the generation of new hESC lines. An increasing portion of new hESC lines represents disease-specific and clinical-grade cell lines. The previously noted usage of only a few early established hESC lines in the vast majority of scientific work is sustained. We also provide a comprehensive overview on clinical trials on the basis of hPSCs. We find that the vast majority of those trials are based on hESC-derived cell products that were generated from an only limited number of relatively old cell lines.

Research in human induced pluripotent stem cells (hiPSCs) is rapidly developing and there are expectations that this research may obviate the need to use human embryonic stem cells (hESCs), the ethics of which has been a subject of controversy for more than 15 years. In this study, we investigated approximately 3,400 original research papers that reported an experimental use of these types of human pluripotent stem cells (hPSCs) and were published from 2008 to 2013. We found that research into both cell types was conducted independently and further expanded, accompanied by a growing intersection of both research fields. Moreover, an in-depth analysis of papers that reported the use of both cell types indicates that hESCs are still being used as a “gold standard,” but in a declining proportion of publications. Instead, the expanding research field is diversifying and hESC and hiPSC lines are increasingly being used in more independent research and application areas.

It is widely accepted that the (now reversed) Bush administration's decision to restrict federal funding for human embryonic stem cell (hESC) research to a few "eligible" hESC lines is responsible for the sustained preferential use of a small subset of hESC lines (principally the H1 and H9 lines) in basic and preclinical research. Yet, international hESC usage patterns, in both permissive and restrictive political environments, do not correlate with a specific type of stem cell policy. Here we conducted a descriptive analysis of hESC line usage and compared the ability of policy-driven processes and collaborative processes inherent to biomedical research to recapitulate global hESC usage patterns. We find that current global hESC usage can be modelled as a cumulative advantage process, independent of restrictive or permissive policy influence, suggesting a primarily innovation-driven (rather than policy-driven) mechanism underlying human pluripotent stem cell usage in preclinical research.

In a recent study published in this journal it was claimed that the rate of publications from US-based authors in the human embryonic stem cell (hESC) research field was slowing or even declining from 2008 to 2010. It was assumed that this is the result of long-term effects of the Bush administration's funding policy for hESC research and the uncertain policy environment of recent years. In the present study, we analyzed a pool of more than 1,700 original hESC research papers published world-wide from 2007 to 2011. In contrast to the previous study, our results do not support the hypothesis of a decline in the productivity of US-based research but rather confirm a nearly unchanged leading position of US research in the hESC field with respect to both publication numbers and impact of research. Moreover, we analyzed about 500 papers reporting original research involving human induced pluripotent stem cells (hiPSCs) published through 2011 and found a dominant position of US research in this research field as well.

Human embryonic stem cells and, more generally, human pluripotent stem cells have attracted much interest for nearly 15 years. The German Stem Cell Act that came into effect on 1 July 2002 strictly regulates research in human embryonic stem cells. This article introduces currently available human pluripotent stem cell types, gives an overview on potential options to use these cells beyond research and summarizes present research activities involving human pluripotent stem cells in Germany. In particular, German research projects with the aim of establishing novel cell models for the detection of human-specific developmental toxicity in vitro are discussed and efforts to develop human germ cells from human pluripotent stem cells are presented.

Pluripotente Stammzellen des Menschen, deren Prototyp die humanen embryonalen Stammzellen (hES-Zellen) sind, stehen seit nunmehr fast 15 Jahren im Fokus des wissenschaftlichen Interesses. Mit dem Inkrafttreten des Stammzellgesetzes am 01.07.2002 wurde die Forschung an hES-Zellen in Deutschland einer gesetzlichen Regelung unterworfen. Der vorliegende Beitrag stellt die derzeit verfügbaren Arten menschlicher pluripotenter Stammzellen vor, gibt einen Überblick über Nutzungsoptionen von hES-Zellen und fasst die Aktivitäten der Forschung an diesen Zellen in Deutschland zusammen. Dabei richtet sich der Blick insbesondere auf Forschungsvorhaben, die der Entwicklung neuer zellbasierter Verfahren zur Analyse von Embryo- und Entwicklungstoxizität auf Grundlage von hES-Zellen dienen und Untersuchungen zur Entwicklung von Keimzellen aus pluripotenten Stammzellen zum Gegenstand haben.

Research on human pluripotent stem cells is rapidly progressing. In the present chapter the current state of research on human embryonic stem cells (hESCs) and human induced pluripotent stem cells (hiPSCs) is analyzed with respect to the number of publicly disclosed cell lines and to the extent and impact of published scientific work involving these cells. Our data reveal that activities in both research fields have markedly increased over the past years and that there are no indications for a diminished role of hESCs in international research as a consequence of the availableness of hiPSCs. Moreover, recent data presented here confirm the global dominance of only a few hESC lines for research, and preferences for distinct hESCs in different countries. Possible causes for these phenomena are discussed.

The use of novel drugs and chemicals requires reliable data on their potential toxic effects on humans. Current test systems are mainly based on animals or in vitro-cultured animal-derived cells and do not or not sufficiently mirror the situation in humans. Therefore, in vitro models based on human pluripotent stem cells (hPSCs) have become an attractive alternative. The article summarizes the characteristics of pluripotent stem cells, including embryonic carcinoma and embryonic germ cells, and discusses the potential of pluripotent stem cells for safety pharmacology and toxicology. Special attention is directed to the potential application of embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) for the assessment of developmental toxicology as well as cardio- and hepatotoxicology. With respect to embryotoxicology, recent achievements of the embryonic stem cell test (EST) are described and current limitations as well as prospects of embryotoxicity studies using pluripotent stem cells are discussed. Furthermore, recent efforts to establish hPSC-based cell models for testing cardio- and hepatotoxicity are presented. In this context, methods for differentiation and selection of cardiac and hepatic cells from hPSCs are summarized, requirements and implications with respect to the use of these cells in safety pharmacology and toxicology are presented, and future challenges and perspectives of using hPSCs are discussed.

Research in human pluripotent stem cells, including human embryonic stem cells (hESC) and human induced pluripotent stem cells (hiPSC), is one of the most dynamic research fields. Despite the high public attention, especially for hESC research, there is only scattered information on the number of hESC lines and the degree, dynamics, and diversification of their use on a global level. In this study we present data on the current number of publicly disclosed hESC lines, on the extent and impact of experimental work involving hESCs, and on the use of specific hESC lines in international research. The results are based on the evaluation of nearly 1,000 research papers published by the end of 2008, which describe experimental work on hESCs, and of a comprehensive database of published hESC lines. The average impact of hESC research papers is high at 7.422, with a predominance of research output by the United States. Of at least 1,071 original hESC lines derived up to November 2009 at 87 institutions in 24 countries, only a fraction is thoroughly characterized. Our data show the global predominance of a few hESC lines in research, but also reveal remarkable country-specific differences. Comparison of hESC and hiPSC application did not show a diminished role for hESC research, but rather revealed that, up to this time, both fields continue to expand, exist independently, and partially overlap.

The teratoma assay is the gold standard for documenting pluripotency of human stem cells. However, reports of new human ESC and iPSC lines vary widely in both methods and analysis of teratoma data. We call for consensus standards to be established to make this assay worthy of its “golden” status.

In the paper by Levine published in the June issue of Cell Stem Cell (Levine, 2008), the author investigated the contri- bution of individual countries to the field of hESC research in relation to another scientific field, research involving RNAi. Under- and overperforming countries with respect to hESC research were des- ignated according to this means, and a positive correlation between stem cell policies and the extent of hESC research was postulated.