Efficient derivation and banking of clinical-grade human embryonic stem cell lines in accordance with Japanese regulations.

Introduction: We recently established clinical-grade human embryonic stem cell (hESC) line KthES11 in accordance with current good manufacturing practice standards in Japan. Despite this success, the establishment efficiency was very low at 7.1% in the first period. Methods: To establish clinical-grade hESC lines, we used xeno-free chemically defined medium StemFit AK03N with the LM-E8 fragments instead of feeder cells. The protocol was then optimized, especially in the early culture phase. Results: We established five hESC lines (KthES12, KthES13, KthES14, KthES15, and KthES16) with 45.5% efficiency. All five hESC lines showed typical hESC-like morphology, a normal karyotype, pluripotent state, and differentiation potential for all three germ layers. Furthermore, we developed efficient procedures to prepare master cell stocks for clinical-grade hESC lines and an efficient strategy for quality control testing. Conclusions: Our master cell stocks of hESC lines may contribute to therapeutic applications using human pluripotent stem cells in Japan and other countries.

Training health professionals to detect and support mothers at risk of postpartum depression or infant abuse in the community: a cross-sectional and a before and after study.

The purpose of this study was to evaluate the 2-day seminar in 2 consecutive years respectively for community health professionals. We prepared the child-rearing support manual (CRSM) and conducted a seminar program to improve skills to provide mental assessments and postnatal care support for mothers and their families in the community using the CRSM. After the seminar in the first year, the first questionnaire was performed regarding the participants' expertise, skills, and system of operations of their facilities. After the seminar in the second year, the same questionnaire was administered. In addition, a questionnaire survey was also administered on the use of the CRSM, etc. for all prefectural health and welfare centers around the nation. As a result, it was found that the participants in both seminars showed significantly higher scores regarding expertise and skills compared with the other participants who had not participated in the seminar in the first year. In comparison of the participants in both seminars between their responses of the first and the second year, significant increases were confirmed in the score of interpersonal health care skills and in the score for system of operation at their institutions. In addition, it was found that the CRSM was used in approximately half of the institutions around the nation. The authors concluded that this seminar program was effective in developing the expertise and skills of individual health professionals, the system of operation of their institutions, and community maternal and child mental health in the nation.