Abstract

In recent years, both stem cell research and the clinical application of these promising cells have increased rapidly. About 1000 clinical trials using stem cells have to date been performed globally. More importantly, more than 10 stem cell-based products have been approved in some countries. With the rapid growth of stem cell applications, some countries have used clinical trials as a tool to diminish the rate of clinical stem cell applications. However, the point at which stem cell clinical trials are essential remains unclear. This commentary discusses when stem cell clinical trials are essential for stem cell transplantation therapies.

Highlights

  • In recent years, both stem cell research and the clinical application of these promising cells have increased rapidly

  • Clinical trials Clinical trials are studies aimed at evaluating whether a proposed new therapy or drug is safe and effective

  • Stem cells as drugs or stem cell drugs are products containing live stem cells that are used as drugs

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Summary

Introduction

Both stem cell research and the clinical application of these promising cells have increased rapidly. Clinical trials Clinical trials are studies aimed at evaluating whether a proposed new therapy or drug is safe and effective. For autologous stem cell therapy, or so-called personalized medicine, the two subgroups include nonexpanded and expanded autologous stem cell transplantation. The main difference between stem cell drugs and other approaches is that stem cell drugs are used to treat a large population of patients using the same source of stem cells.

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