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.

Research in human embryonic stem cells (hESCs) is a rapidly developing scientific field. In this study we collect and evaluate a thorough body of data on the current number of publicly disclosed hESC lines and the extent and impact of scientific work involving the use of these cells. These data contribute to the substantiation of the discussion on the current status of hESC research, provide a basis for the analysis of the status of such research, and uncover further needs in terms of registration, banking, standardization, and tracing.

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. Stem Cells 2010;28:240–246

SummaryThe 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.

Objective Diagnosis of a glioblastoma (GBM) is triggered by the onset of symptoms and based on cerebral imaging and histological examination. Serum based biomarkers may support detection of GBM. Here, we explored serum protein concentrations in GBM patients and used data mining to explore profiles of biomarkers and whether these associate with clinical status of the GBM patients. Methods Gene and protein expression data for astrocytoma and GBM were used to identify secreted proteins differentially expressed in tumors versus normal brain tissues. The tumor expression and serum concentrations of 14 candidate proteins were analyzed in 23 GBM patients and 9 healthy subjects. Data mining methods involving all 14 proteins were applied as an initial evaluation step to find clinically informative profiles. Results Data mining identified a serum protein profile formed by BMP2, HSP70 and CXCL10 that allowed correct assignment into the GBM group with a specificity and sensitivity of 89% and 96%, respectively (p<0.0001, Fischer's exact test). Survival after tumor resection for more than 15 month was associated with a profile formed by TSP1, HSP70 and IGFBP3, allowing correct assignments in all cases (p<0.0001, Fischer's exact test). No correlation was found with tumor size and age of the patient. Conclusion The study shows that robust serum profiles for GBM may be identified by data mining based on a relatively small study cohort. Profiles of more than one biomarker allow a more specific assignment to the GBM and survival group than single proteins, confirming earlier attempts to correlate single markers with cancer. These findings will be a basis for validation in a larger sample size.