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Stem Cell Safety and Sterility Testing: A Promising Approach in Regenerative Medicine

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Stem Cell Production

Abstract

Stem cells and their derivatives are considered as most sought-after and well-received therapeutic agents in the field of regenerative medicines. As we know, stem cells are naïve cells which have the ability to differentiate into multiple lineages, thus making them an ideal candidate for cell-based therapeutics. In the field of clinical research especially in transplantation studies, stem cells play a very crucial and specific role. The transplantation experiments/studies demand heavy use of immunosuppressive agents in the patient for appropriate grafting and acclimatization of the tissue into the recipient’s body. If the transplanted cells/tissue/cell-derived product is contaminated, it can lead to the deterioration of the graft. Like other cells, stem cells also have issues regarding safety and sterility. If the sterility of stem cells is compromised at any stage of therapeutic application, it renders the entire process unfit to proceed. As the field of cell-based therapies is expanding with new laboratories and manufacturers budding every day, it has become important that such industries and labs should have a thorough comprehension of the regulatory guidelines that govern the microbiological and non-microbiological testing of stem cell-based therapeutics. In this chapter, we are going to discuss the importance of stem cells as therapeutic agents with an overview of how to ensure safety, sterility, and efficacy of such therapies. We have attempted to highlight the importance of numerous regulations such as that of the Food and Drug Administration (FDA) and multifaceted areas like Good Manufacturing Practices (GMPs) and several other regulating bodies which have provided us with internationally acceptable laws to ensure the safe and efficient usage of stem cells as therapeutics.

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Acknowledgments

The author would like to thank the Deanship of Scientific Research at Majmaah University for supporting this work.

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The authors of the manuscript declare no conflicts of interest/competing interests. All data and materials are available in the manuscript.

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Authors and Affiliations

  1. System Toxicology and Health Risk Assessment Group, CSIR-Indian Institute of Toxicology Research (CSIR-IITR), Vishvigyan Bhawan, Lucknow, India

    Pankhi Vatsa & Uzair Ahmad Ansari

  2. Academy of Scientific and Innovative Research (AcSIR), CSIR-Human Resource Development Centre, (CSIR-HRDC) Campus, Ghaziabad, Uttar Pradesh, India

    Pankhi Vatsa & Uzair Ahmad Ansari

  3. Department of Medical Laboratories, College of Applied Medical Science, Majmaah University, Al Majma’ah, Kingdom of Saudi Arabia

    Sadaf Jahan, Shabir Ahmad Mir, Bader Alshehri & Ranjay Kumar Choudhary

  4. Department of Toxicology and Pharmacology, College of Pharmacy, Jazan University, Al Majma’ah, Kingdom of Saudi Arabia

    Andleeb Khan

  5. Department of Biology, College of Science, Hail University, Al Majma’ah, Kingdom of Saudi Arabia

    Arif Jamal Siddiqui

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  1. Pankhi Vatsa
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  1. Department of Stem Cell Biology, Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia

    Firdos Alam Khan

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Vatsa, P. et al. (2022). Stem Cell Safety and Sterility Testing: A Promising Approach in Regenerative Medicine. In: Khan, F.A. (eds) Stem Cell Production. Springer, Singapore. https://doi.org/10.1007/978-981-16-7589-8_9

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