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Review
. 2021 Nov;10 Suppl 2(Suppl 2):S85-S95.
doi: 10.1002/sct3.13035.

Developing standards to support the clinical translation of stem cells

Jiani Cao  1   2 , Jie Hao  1   2 , Lei Wang  1   2 , Yuanqing Tan  1   2 , Yuchang Tian  1   2   3 , Shiyu Li  1   2   3 , Aijin Ma  4 , Boqiang Fu  5 , Jianwu Dai  3   6 , Peijun Zhai  7 , Peng Xiang  8 , Yong Zhang  9 , Tao Cheng  10 , Yaojin Peng  1   2   3 , Qi Zhou  1   2   3 , Tongbiao Zhao  1   2   3
Affiliations
Review

Developing standards to support the clinical translation of stem cells

Jiani Cao et al. Stem Cells Transl Med. 2021 Nov.

Abstract

Stem cells, which could be developed as starting or raw materials for cell therapy, hold tremendous promise for regenerative medicine. However, despite multiple fundamental and clinical studies, clinical translation of stem cells remains in the early stages. In contrast to traditional chemical drugs, cellular products are complex, and efficacy can be altered by culture conditions, suboptimal cell culture techniques, and prolonged passage such that translation of stem cells from bench to bedside involves not only scientific exploration but also normative issues. Establishing an integrated system of standards to support stem cell applications has great significance in efficient clinical translation. In recent years, regulators and the scientific community have recognized gaps in standardization and have begun to develop standards to support stem cell research and clinical translation. Here, we discuss the development of these standards, which support the translation of stem cell products into clinical therapy, and explore ongoing work to define current stem cell guidelines and standards. We also introduce general aspects of stem cell therapy and current international consensus on human pluripotent stem cells, discuss standardization of clinical-grade stem cells, and propose a framework for establishing stem cell standards. Finally, we review ongoing development of international and Chinese standards supporting stem cell therapy.

Keywords: cell therapy; clinical translation; standard; stem cell.

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Conflict of interest statement

The authors declared no potential conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Preclinical processes for cell preparation and evaluation. The cell preparation process includes donation of biological source material, establishment of cell lines, and in vitro characterization of cellular preparations. Preclinical evaluation includes in vivo analysis of efficacy and safety
FIGURE 2
FIGURE 2
Stem cell standard systems. Quality standards specify the acceptance criteria of critical quality attributes of stem cell products, separating the acceptability from unacceptability. Method standards, which specify the requirements for evaluation of the critical quality attributes of cell products, facilitate implementation of quality standards. Process standards specify the management requirements supporting the whole operating process, thus ensuring the accuracy of testing results and quality of final cell products
See this image and copyright information in PMC

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