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Overview of Cellular Therapeutics Clinical Trials: Advances, Challenges, and Future Directions

Meizhai Guo1, Bingyi Zheng1, Xiaoling Zeng1

  • 1Translational Medicine Research Center, School of Pharmaceutical Sciences, Xiamen University, Xiamen 361102, China.

International Journal of Molecular Sciences
|June 26, 2025
PubMed

Insights

Cellular therapies show promise for degenerative diseases and cancer, but face challenges. Integrating traditional Chinese medicine (TCM) may improve cell viability and overcome these barriers for better clinical translation.

Area of Science:

  • Regenerative Medicine
  • Immunotherapy
  • Oncology

Background:

  • Cellular therapeutics, including stem cells and engineered immune cells, show efficacy but face low engraftment and limited long-term success.
  • Translational barriers hinder the clinical application of cell therapies.

Purpose of the Study:

  • To review clinical cell therapy projects in China over the past five years.
  • To analyze global clinical achievements and identify therapeutic improvements.
  • To propose integrating traditional Chinese medicine (TCM) to enhance cell therapy efficacy.

Main Methods:

  • Compilation of clinical projects on cell therapy in China (172 trials, >1200 patients).
  • Analysis of published global clinical achievements in cell therapy.
  • Review of proposed mechanisms for TCM integration (CXCR4 upregulation, mitochondrial biogenesis).

Main Results:

  • Significant therapeutic improvements observed in degenerative disorders (40-60% WOMAC score improvement) and oncology (78% ctDNA clearance).
  • Rapid development and diverse applications of cell therapy highlighted.
  • Identified limitations in TCM validation (72% lacking single-cell omics) and regulatory issues.

Conclusions:

  • Cellular therapeutics offer significant therapeutic potential, particularly in degenerative diseases and oncology.
  • Integrating TCM bioactive compounds presents a promising strategy to enhance cell viability and overcome translational barriers.
  • Future research should focus on randomized trials and standardized TCM-cell therapy protocols to facilitate clinical translation.
Keywords:
CAR-TMSCcancercellular therapeuticsdegeneration diseasestraditional Chinese medicine

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