| Theme |
Bone tissue regeneration |
| Title |
Clinical applications and cell processing |
| Author |
Akira Oshima |
Research Institute for Cell Engineering, National Institute of Advanced Industrial Science and Technology (AIST) |
| Author |
Hiroko Machida |
Research Institute for Cell Engineering, National Institute of Advanced Industrial Science and Technology (AIST) |
| Author |
Hajime Ohgushi |
Research Institute for Cell Engineering, National Institute of Advanced Industrial Science and Technology (AIST) |
| [ Summary ] |
When clinical research using human cells is performed, it is necessary to create a research program that considers both safety and ethics. It is important to use cells the safety of which has been confirmed, as well as cells cultured by correct operating procedures, using structural equipment maintained in a hygienic environment. To maintain such quality control, we introduced ISO13485 as our quality management system for medical equipment. Though practice standards for clinical research have not been clearly delineated by law or other restrictions, it seems that structural equipments and a quality management system equal to that of pharmaceutical and medical equipment manufacturers are demanded by the notification of an impending enforcement schedule for clinical research laboratories this coming September. |