A Manually Curated Database on Clinical Studies Involving Cell Products Derived from Human Pluripotent Stem Cells

• Published in: Stem cell reports 2020-08, Vol.15 (2), p.546-555
• Main Authors: Kobold, Sabine, Guhr, Anke, Mah, Nancy, Bultjer, Nils, Seltmann, Stefanie, Seiler Wulczyn, Andrea E.M., Stacey, Glyn, Jie, Hao, Liu, Wang, Löser, Peter, Kurtz, Andreas
• Format: Article
• Language: English
• Subjects: clinical study database; embryonic stem cell; pluripotent stem cell
• ISSN: 2213-6711; 2213-6711
• DOI: 10.1016/j.stemcr.2020.06.014

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. •Establishment of a database for clinical studies based on pluripotent stem cells•54 clinical studies identified from public sources•Majority of studies based on embryonic stem cells•Strong increase in studies based on induced pluripotent stem cells in last 2 years In this article, Kurtz and colleagues provide a comprehensive overview of clinical studies using cells derived from human pluripotent stem cells. They show that although the majority of studies still used embryonic stem cells, the number of studies based on induced pluripotent stem cells is rapidly increasing. An hPSC-focused clinical study database was established on the hPSCreg platform.