Strategic Considerations for Quality Management of Products for Stem Cell Therapy

In the past 50 years, significant progress has been made in the application of stem cell therapy in the medical field, from new discoveries in the basic research to its increasingly important role in life sciences. With its advancement in R&D and particularly, in clinical translation, it is no longer just a dream to put stem cell therapy into practical application for the treatment of life-threatening diseases, organ regeneration and other medical needs still unmet. Today, clinical application of stem cell therapy has been garnering strong support from government, industry and investment communities in many countries in the US, Europe and Asia. It would only be a matter of time before stem cell therapy realizes its large scale commercialization, and in turn, its benefit to human health. However, the history of stem cell therapy is filled with dramatic ups and downs or even fatal blows, and many challenges still exist today, including large differences in how they are regulated by health authorities in different countries. This article presents the key quality management strategies of these new therapies by summarizing the special characteristics of stem cell therapies, existing government policies and emerging regulatory trends from different regions in the world, the guiding principles and important aspects for considerations in quality control. This would serve the purpose of providing insights and guidance to current institutions and companies in stem cell therapy, which in turn, ensures better quality control of the safety and efficacy of novel stem cell therapies.