This chapter explores the establishment of clinical-grade standards for dental stem cell (DSC) banking and its transformative role in regenerative therapy and personalized medicine. DSCs, derived from noninvasively obtained tissues, demonstrate promising proliferative ability, multilineage differentiation potential, and immunomodulatory capacity, positioning them as valuable therapeutic resources. Here, we review the developmental and anatomical origins of DSCs, their regenerative potential, and several clinical successes in tissue repair and regeneration. We detail the rigorous operational and regulatory protocols that ensure the safety and efficacy of DSC-based therapies, focusing on compliance with Japan’s Act on the Safety of Regenerative Medicine (ASRM). At the cell processing facility (CPF) of our Dental Cell Bank, a specialized platform for cultivating and storing patient-derived (autologous) DSCs, board-certified specialists manage each stage of cell isolation, culture, and cryopreservation, adhering to stringent quality control and standard operating procedures (SOPs). Additionally, we discuss pre-extraction assessments for identifying cell-bankable teeth, sterility considerations, and patient guidelines. These procedures are coordinated by certified dental practitioners recognized by our Dental Cell Bank and are critical for maintaining cell viability, reducing contamination risks, and optimizing quality. This chapter aims to advance the use of DSCs as a reliable, accessible resource for regenerative therapy, fostering new avenues for clinical application and contributing to the future of personalized medicine.

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Establishing Clinical-Grade Standards for Dental Stem Cell Banking: A Pathway to Regenerative Therapy and Personalized Medicine

  • Mai Mochizuki,
  • Tomoko Kobayashi,
  • Taka Nakahara

摘要

This chapter explores the establishment of clinical-grade standards for dental stem cell (DSC) banking and its transformative role in regenerative therapy and personalized medicine. DSCs, derived from noninvasively obtained tissues, demonstrate promising proliferative ability, multilineage differentiation potential, and immunomodulatory capacity, positioning them as valuable therapeutic resources. Here, we review the developmental and anatomical origins of DSCs, their regenerative potential, and several clinical successes in tissue repair and regeneration. We detail the rigorous operational and regulatory protocols that ensure the safety and efficacy of DSC-based therapies, focusing on compliance with Japan’s Act on the Safety of Regenerative Medicine (ASRM). At the cell processing facility (CPF) of our Dental Cell Bank, a specialized platform for cultivating and storing patient-derived (autologous) DSCs, board-certified specialists manage each stage of cell isolation, culture, and cryopreservation, adhering to stringent quality control and standard operating procedures (SOPs). Additionally, we discuss pre-extraction assessments for identifying cell-bankable teeth, sterility considerations, and patient guidelines. These procedures are coordinated by certified dental practitioners recognized by our Dental Cell Bank and are critical for maintaining cell viability, reducing contamination risks, and optimizing quality. This chapter aims to advance the use of DSCs as a reliable, accessible resource for regenerative therapy, fostering new avenues for clinical application and contributing to the future of personalized medicine.