Abstract
Regenerative therapies, including both gene and cellular therapies, aim to induce regeneration of cells, tissues and organs and restore their functions. In this short Spotlight, we summarize the latest advances in cellular therapies using pluripotent stem cells (PSCs), highlighting the current status of clinical trials using induced (i)PSC-derived cells. We also discuss the different cellular products that might be used in clinical studies, and consider safety issues and other challenges in iPSC-based cell therapy.
Highlights
Cellular regenerative therapies seek to use cells transplanted into a patient to restore the impaired functions of living tissues and organs
We are at a point where therapies using pluripotent stem cells (PSCs) are becoming a reality: evidenced by the increasing number of applications for human clinical trials submitted to the Food and Drug Administration (FDA) each year
A total of 636 clinical trials (Phase I: 242; Phase II: 348; Phase III: 46) were under way worldwide as of the end of the third quarter of 2019: these can be classified as gene-modified cellular therapy trials (418) and cellular therapy trials (218) (Q3 2019 Report, Alliance for Regenerative Medicine: https://alliancerm.org/publication/q3-2019-data-report/)
Summary
Cellular regenerative therapies seek to use cells transplanted into a patient to restore the impaired functions of living tissues and organs. There are high hopes that cellular therapies, stem cellbased therapies, may provide a fundamental treatment option for conditions that cannot yet be treated with conventional drugs. The sources for cellular therapy include tissue stem cells (of adult or fetal origin) and pluripotent stem cells (PSCs), including both embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs). We are at a point where therapies using PSCs are becoming a reality: evidenced by the increasing number of applications for human clinical trials submitted to the Food and Drug Administration (FDA) each year. We aim to describe the current status and future directions of planned/ongoing clinical trials of stem cell-based cellular therapy
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