Cytotherapy, 2015; 17: 1008
LETTER TO THE EDITOR
Rules of providing cord blood for induced pluripotent stem cells for research
SATOSHI NISHIWAKI Office for Transplantation Medicine, Health Service Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan Induced pluripotent stem cell (iPSC)-derived tissue or organs have significant potential to change transplantation medicine [1,2], and cord blood (CB) is a prospective source of iPSCs [3] through the help of CB banks. The major advantages of the use of CB banks for transplantation are (i) human leukocyte antigen (HLA) is known, (ii) available to safely administer to patients and (iii) it is risk-free for donors. Regulating stem cell therapies is essential [4] and necessitates quality assurance of cell sources. As such, The Act for Appropriate Provision of Hematopoietic Stem Cells to be Used in Transplantations (2012) (http://www. jshct.com/english/pdf/act_en.pdf) was put into operation in Japan in January 2014. The provision specifies out that licensed public CB banks must comply with the relevant standards stipulated by the Ministry of Health, Labour and Welfare ordinances. Public CB banks sometimes have a dilemma over whether or not to provide CB for research purposes in the clinical setting, when it can be used for usual CB transplantation. In response to this situation, CB units that meet safety standards are stocked in licensed public CB banks and divided into two grades. Grade A1 CB is harvested within the last 10 years and has a high nucleated cell count for transplantation (currently 8 108). Grade A2 CB is harvested more than 10 years ago or has a lower nucleated cell count for transplantation. Public CB banks can therefore prioritize assistance to researchers by providing grade A2, which has HLA data and meets safety standards. Grade A2 CB can be used for iPSCs and has various other clinical research applications. According to relevant regulations, ethical matters differ, depending on whether the research involves gene analyses and/or alters the nature of cells.
Research protocols involving the use of CB should gain the approval of the ethics review boards of both the public CB bank and the research institution. Public CB banks give general descriptions of possible research applications of CB to expectant mothers. However, it is impossible to explain the specific details of future research at that time. Therefore, researchers should explain the details themselves and obtain written consent from the donor of the CB (birth mother and/or the child) before receiving the CB. The mother has the right to reject the research use of her CB in advance and the right not to be contacted after the follow-up period. Although there is no stipulated period for the storage of individual information related to CB, the CB bank should discard the data properly, along with disposal of the CB. These clear and rational rules including safety, quality, fairness and ethical issues can promote effective utilization of CB from public CB banks for regenerative medicine. Disclosure of interests: The author has no commercial, proprietary, or financial interest in the products or companies described in this article. References [1] Realising the potential of stem-cell research in Europe. Lancet 2013;382:1609. [2] Fox IJ, Daley GQ, Goldman SA, Huard J, Kamp TJ, Trucco M. Stem cell therapy. Use of differentiated pluripotent stem cells as replacement therapy for treating disease. Science 2014;345:1247391. [3] Hasse A, Olmer R, Schwanke K, Wunderlich S, Merkert S, Hess C, et al. Generation of induced pluripotent stem cells from human cord blood. Cell Stem Cell 2009;5:434e41. [4] Unknown territory. Nature 2013;494:5.
Correspondence: Satoshi Nishiwaki, MD, PhD, Office for Transplantation Medicine, Health Service Bureau, Ministry of Health, Labour and Welfare, 1-2-2 Kasumigaseki Chiyoda-ku, Tokyo 100-8916, Japan. E-mail: [email protected] (Received 22 January 2015; accepted 24 February 2015) ISSN 1465-3249 Copyright Ó 2015, International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jcyt.2015.03.606
LETTER TO THE EDITOR
Rules of providing cord blood for induced pluripotent stem cells for research
SATOSHI NISHIWAKI Office for Transplantation Medicine, Health Service Bureau, Ministry of Health, Labour and Welfare, Tokyo, Japan Induced pluripotent stem cell (iPSC)-derived tissue or organs have significant potential to change transplantation medicine [1,2], and cord blood (CB) is a prospective source of iPSCs [3] through the help of CB banks. The major advantages of the use of CB banks for transplantation are (i) human leukocyte antigen (HLA) is known, (ii) available to safely administer to patients and (iii) it is risk-free for donors. Regulating stem cell therapies is essential [4] and necessitates quality assurance of cell sources. As such, The Act for Appropriate Provision of Hematopoietic Stem Cells to be Used in Transplantations (2012) (http://www. jshct.com/english/pdf/act_en.pdf) was put into operation in Japan in January 2014. The provision specifies out that licensed public CB banks must comply with the relevant standards stipulated by the Ministry of Health, Labour and Welfare ordinances. Public CB banks sometimes have a dilemma over whether or not to provide CB for research purposes in the clinical setting, when it can be used for usual CB transplantation. In response to this situation, CB units that meet safety standards are stocked in licensed public CB banks and divided into two grades. Grade A1 CB is harvested within the last 10 years and has a high nucleated cell count for transplantation (currently 8 108). Grade A2 CB is harvested more than 10 years ago or has a lower nucleated cell count for transplantation. Public CB banks can therefore prioritize assistance to researchers by providing grade A2, which has HLA data and meets safety standards. Grade A2 CB can be used for iPSCs and has various other clinical research applications. According to relevant regulations, ethical matters differ, depending on whether the research involves gene analyses and/or alters the nature of cells.
Research protocols involving the use of CB should gain the approval of the ethics review boards of both the public CB bank and the research institution. Public CB banks give general descriptions of possible research applications of CB to expectant mothers. However, it is impossible to explain the specific details of future research at that time. Therefore, researchers should explain the details themselves and obtain written consent from the donor of the CB (birth mother and/or the child) before receiving the CB. The mother has the right to reject the research use of her CB in advance and the right not to be contacted after the follow-up period. Although there is no stipulated period for the storage of individual information related to CB, the CB bank should discard the data properly, along with disposal of the CB. These clear and rational rules including safety, quality, fairness and ethical issues can promote effective utilization of CB from public CB banks for regenerative medicine. Disclosure of interests: The author has no commercial, proprietary, or financial interest in the products or companies described in this article. References [1] Realising the potential of stem-cell research in Europe. Lancet 2013;382:1609. [2] Fox IJ, Daley GQ, Goldman SA, Huard J, Kamp TJ, Trucco M. Stem cell therapy. Use of differentiated pluripotent stem cells as replacement therapy for treating disease. Science 2014;345:1247391. [3] Hasse A, Olmer R, Schwanke K, Wunderlich S, Merkert S, Hess C, et al. Generation of induced pluripotent stem cells from human cord blood. Cell Stem Cell 2009;5:434e41. [4] Unknown territory. Nature 2013;494:5.
Correspondence: Satoshi Nishiwaki, MD, PhD, Office for Transplantation Medicine, Health Service Bureau, Ministry of Health, Labour and Welfare, 1-2-2 Kasumigaseki Chiyoda-ku, Tokyo 100-8916, Japan. E-mail: [email protected] (Received 22 January 2015; accepted 24 February 2015) ISSN 1465-3249 Copyright Ó 2015, International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jcyt.2015.03.606
