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Peer-reviewedCC BY-NC-NDSignal Transduction and Targeted Therapy

Clinical translational research on stem cell products: prospects and challenges

  • Shuang Chen1
  • Lin ZHANG1
  • Yushuang Ren1
  • Xue Bai1
  • Xiao Wei1
  • Maoyue Chai1
  • 崔苏甦1
  • Xinran Zhao1
  • Hongxin Deng2
  1. 1Department of Biotherapy, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China
  2. 2Department of Biotherapy, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China. [email protected]
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Abstract

Stem cell therapy has shown significant efficacy as a viable treatment for several resistant diseases. Despite the increasing number of stem cell products on the market worldwide, the clinical translational application of stem cell products still faces many challenges. This review presents a comprehensive analysis and overview of registered stem cell clinical trials and commercialized stem cell products globally, emphasizing their applicability and promise in clinical translational research. The extensive production and quality assurance of clinical-grade stem cell products is crucial for clinical application and serves as the foundation for guaranteeing product safety and efficacy. We propose and discuss the establishment of standardized methods for the manufacture and quality assurance of stem cell products. In response to the challenges encountered by stem cell products in clinical translational applications, we propose strategies to enhance the efficacy and safety of these products in terms of heterogeneity, administration methods, co-transplantation, Good Manufacturing Practices (GMPs), transplant locations, genetic modifications, biomaterials, and culture conditions. These advancements require multidisciplinary cooperation and ongoing inventive research to provide more effective and safer treatment alternatives for a greater number of patients, thereby broadening the therapeutic applications of stem cell products and establishing a platform for subsequent advancements in regenerative medicine.

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Cite

BibTeXRIS
BibTeX
@article{chen2026clinical,
  title = {{Clinical translational research on stem cell products: prospects and challenges}},
  author = {Shuang Chen and Lin ZHANG and Yushuang Ren and Xue Bai and Xiao Wei and Maoyue Chai and 崔苏甦 and Xinran Zhao and Hongxin Deng},
  journal = {Signal Transduction and Targeted Therapy},
  year = {2026},
  month = may,
  doi = {10.1038/s41392-026-02582-y},
  url = {https://doi.org/10.1038/s41392-026-02582-y},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Clinical translational research on stem cell products: prospects and challenges
AU  - Shuang Chen
AU  - Lin ZHANG
AU  - Yushuang Ren
AU  - Xue Bai
AU  - Xiao Wei
AU  - Maoyue Chai
AU  - 崔苏甦
AU  - Xinran Zhao
AU  - Hongxin Deng
PY  - 2026
DA  - 2026/05/13
JO  - Signal Transduction and Targeted Therapy
DO  - 10.1038/s41392-026-02582-y
UR  - https://doi.org/10.1038/s41392-026-02582-y
AB  - Stem cell therapy has shown significant efficacy as a viable treatment for several resistant diseases. Despite the increasing number of stem cell products on the market worldwide, the clinical translational application of stem cell products still faces many challenges. This review presents a comprehensive analysis and overview of registered stem cell clinical trials and commercialized stem cell products globally, emphasizing their applicability and promise in clinical translational research. The extensive production and quality assurance of clinical-grade stem cell products is crucial for clinical application and serves as the foundation for guaranteeing product safety and efficacy. We propose and discuss the establishment of standardized methods for the manufacture and quality assurance of stem cell products. In response to the challenges encountered by stem cell products in clinical translational applications, we propose strategies to enhance the efficacy and safety of these products in terms of heterogeneity, administration methods, co-transplantation, Good Manufacturing Practices (GMPs), transplant locations, genetic modifications, biomaterials, and culture conditions. These advancements require multidisciplinary cooperation and ongoing inventive research to provide more effective and safer treatment alternatives for a greater number of patients, thereby broadening the therapeutic applications of stem cell products and establishing a platform for subsequent advancements in regenerative medicine.
SN  - 2059-3635
SN  - 2095-9907
ER  -