2012 Volume 55 Issue 4 Pages 272-277
Purpose: In preclinical studies in dogs, the safety and efficacy of pulp regeneration following autologous transplantation of pulp stem cells into the root canal after pulpectomy have been established. However, the challenges for clinical trials of this cell therapy of pulp regeneration are, when the cell processing center is not located in the clinical dental office, to transport the extracted tooth to the cell processing center, and to return the processed cells to the clinical office. Therefore, in this study, the "Principles of clinical studies using human stem cells" were followed, and the standard operation procedure (SOP) for transportation of teeth in less than 12 hours was established to ensure the stable and safe transportation of teeth. Methods: First, the tooth was transported while controlling the temperature using a special container for transport. Optimal transportation solution and antibiotics were selected by the rate of cell survival and adhesion 12 hours after transportation to establish SOP. Furthermore, safety tests for bacteria, fungi, viruses, endotoxins, and mycoplasma were performed in the transportation solution after use, the primary cell culture medium and finally frozen cells at the 7th passage manufactured in an isolator of the cell processing center, confirming the safety of transportation of teeth using this SOP. Results: When Hanks' Balanced Salt Solution containing 20 μg/ml gentamicin and 0.25 μg/ml amphotericin B was used, survival rate was 98%, and cell adhesion rate was high, indicating that it is the optimal solution for transportation of teeth. Using this SOP, although the aerobic bacteria and endotoxins in the tooth transportation solution were slightly higher, finally frozen pulp stem cells were negative in all safety examinations. Conclusion: Thus, it is concluded that teeth can be transported in a safe and stable manner using this standardized method.
