Ethical and Regulatory Considerations in the Clinical Translation of Pluripotent Stem Cell‐Derived
                    NK
                    Cell Therapies

Qianwen Chen; Jianwei Lv; Xinwei Xie; Hanlin Zhu; Zhenyu Xiao; Yaojin Peng

doi:10.1111/cpr.70129

journal article Open Access Sep 29, 2025

Ethical and Regulatory Considerations in the Clinical Translation of Pluripotent Stem Cell‐Derived NK Cell Therapies

Qianwen Chen

Jianwei Lv Xinwei Xie Hanlin Zhu Zhenyu Xiao

Yaojin Peng

Cell Proliferation Vol. 59 No. 4 · Wiley

View at Publisher Save 10.1111/cpr.70129

Abstract

ABSTRACT
Advancements in the generation of human pluripotent stem cell‐derived natural killer (PSC‐NK) cells have attracted considerable attention within the biomedical research community, offering a promising off‐the‐shelf technique for universal immune therapy. However, this technique is associated with certain ethical, safety, and regulatory challenges, including ensuring genomic stability, preventing contamination and adhering to rigorous ethical standards for cell sourcing and obtaining informed consent. Addressing these challenges would require robust quality control, transparent data‐sharing practices, and cross‐border collaboration to ensure alignment with ethical and scientific standards. Future development must therefore focus on patient safety, data privacy and equitable access within a comprehensive ethical framework. These measures are crucial for maintaining public trust in and enabling the responsible clinical integration of PSC‐NK therapies, thereby supporting their advancement while maintaining a balance between innovation and societal and ethical considerations.

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Details

Published: Sep 29, 2025
Vol/Issue: 59(4)
License: View

Authors

Q

Qianwen Chen

State Key Laboratory of Organ Regeneration and Reconstruction Institute of Zoology, Chinese Academy of Sciences Beijing China; Beijing Institute for Stem Cell and Regenerative Medicine Beijing China

J

Jianwei Lv

School of Life Sciences Xiamen University Xiamen China

X

Xinwei Xie

School of Life Science Beijing Institute of Technology Beijing China

H

Hanlin Zhu

School of Life Science Beijing Institute of Technology Beijing China

Z

Zhenyu Xiao

School of Life Science Beijing Institute of Technology Beijing China

Y

Yaojin Peng

State Key Laboratory of Organ Regeneration and Reconstruction Institute of Zoology, Chinese Academy of Sciences Beijing China; Beijing Institute for Stem Cell and Regenerative Medicine Beijing China; University of the Chinese Academy of Sciences Beijing China

Funding

Chinese Academy of Sciences Award: XDC0200301

Youth Innovation Promotion Association of the Chinese Academy of Sciences Award: 2021080

Cite This Article

Qianwen Chen, Jianwei Lv, Xinwei Xie, et al. (2025). Ethical and Regulatory Considerations in the Clinical Translation of Pluripotent Stem Cell‐Derived NK Cell Therapies. Cell Proliferation, 59(4). https://doi.org/10.1111/cpr.70129

Ethical and Regulatory Considerations in the Clinical Translation of Pluripotent Stem Cell‐Derived NK Cell Therapies

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