Shah N N, Wayne A S, Grady C, Fry T, Wendler D
Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
1] Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA [2] Children's Center for Cancer and Blood Diseases, Children's Hospital of Los Angeles, University of Southern California, Los Angeles, CA, USA.
Bone Marrow Transplant. 2015 Jan;50(1):15-9. doi: 10.1038/bmt.2014.224. Epub 2014 Oct 20.
With increasing frequency, allogeneic hematopoietic cell transplantation involving children is being performed in the research setting. Allogeneic hematopoietic cell transplantation, however, cannot be performed without a hematopoietic stem cell (HSC) donor. This donor is often a sibling of the recipient and may also be a child. In such circumstances, it is unclear whether or how the federal regulations for pediatric research apply to the minor donors. This introductory paper reviews the issues to be considered while evaluating studies that use HSCs obtained from minor donors and identifies areas where further research is needed. In the era of increasing applicability for donor-derived cellular therapies, we provide a suggested framework for determining when minor donors qualify as human research subjects and when their participation can be approved under the federal regulations.
在研究环境中，涉及儿童的异基因造血细胞移植越来越频繁。然而，没有造血干细胞（HSC）供体就无法进行异基因造血细胞移植。该供体通常是受者的兄弟姐妹，也可能是儿童。在这种情况下，尚不清楚联邦儿科研究法规是否适用于未成年供体以及如何适用。这篇介绍性论文回顾了在评估使用来自未成年供体的造血干细胞的研究时需要考虑的问题，并确定了需要进一步研究的领域。在供体来源的细胞疗法适用性不断提高的时代，我们提供了一个建议框架，以确定未成年供体何时符合人类研究受试者的条件，以及何时可以根据联邦法规批准他们的参与。
