The world’s first clinical trial for an aplastic anemia patient with thrombocytopenia administering platelets generated from autologous iPS cells
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On September 21, 2018, the Japanese Ministry of Health, Labor and Welfare announced it had approved a plan for the first-ever use of an experimental therapy on a patient with aplastic anemia and thrombocytopenia, which will involve the infusion of platelets generated from an autologous induced pluripotent stem cells (iPSCs). The patient had a history of rejection reactions to allogeneic platelets.
Nature Editorial previously questioned Japan’s efforts to hasten development and clinical application of iPSC-derived products on both scientific and ethical grounds , especially with respect to the implementation of ‘fast-track’ approval leading to the first-in-human trials of allogeneic iPS stock cells. However, we applaud this trial of iPSC-derived platelets. It stands as a beacon, modeling both ethical and scientific integrity. Future clinical research with iPSC-derived products can look here for guidance.
The current trial was arrived at by a circuitous route. As originally conceived,...
AA: conceptualization, writing—original draft, writing—review and editing. EN: conceptualization, formal analysis, writing—review and editing. NJ: conceptualization, writing—review and editing.
Compliance with ethical standards
Conflict of interest
AA is President of the Japan Association for Bioethics; this paper reflects the author’s personal academic analyses and opinions and does not represent JAB’s official position. EN and NSJ have no conflict of interest to declare.
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