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The world’s first clinical trial for an aplastic anemia patient with thrombocytopenia administering platelets generated from autologous iPS cells

  • Akira Akabayashi
  • Eisuke Nakazawa
  • Nancy S. Jecker
Letter to the Editor
  • 34 Downloads

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 [1], 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,...

Notes

Author contributions

AA: conceptualization, writing—original draft, writing—review and editing. EN: conceptualization, formal analysis, writing—review and editing. NJ: conceptualization, writing—review and editing.

Funding

None.

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.

References

  1. 1.
    Nature Editorials. Racing hearts. Japan must show that a promising therapy for damaged hearts works as claimed. Week Nat. 2018;557:611–2.Google Scholar
  2. 2.
    Ito Y, Nakamura S, Sugimoto N, Shigemori T, Kato Y, Ohno M, et al. Turbulence activates platelet biogenesis to enable clinical scale ex vivo production. Cell 2018;174(3):636–48.  https://doi.org/10.1016/j.cell.2018.06.011 (Epub 2018 Jul 12).CrossRefGoogle Scholar
  3. 3.
    Akabayashi A, Nakazawa E, Jecker NS. Tighten up clinical trial of stem cells. Nature. 2018;560:431.  https://doi.org/10.1016/j.cell.2018.06.011.CrossRefGoogle Scholar

Copyright information

© Japanese Society of Hematology 2018

Authors and Affiliations

  1. 1.Department of Biomedical Ethics, Faculty of MedicineThe University of TokyoTokyoJapan
  2. 2.Division of Medical Ethics, Department of Population HealthNew York University School of MedicineNew YorkUSA
  3. 3.Department of Bioethics and HumanitiesUniversity of Washington School of MedicineSeattleUSA
  4. 4.African Centre for Epistemology and Philosophy of ScienceUniversity of JohannesburgJohannesburgSouth Africa

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