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Cryopreservation practices in clinical and preclinical iPSC-based cell therapies: Current challenges and future

Michael Dobruskin1, Geoffrey Toner1, Ronald Kander1

  • 1Jefferson Institute for Bioprocessing, Thomas Jefferson University, Spring House, Pennsylvania, USA.

Biotechnology Progress
|April 2, 2025
PubMed

Insights

Cryopreservation of induced pluripotent stem cells (iPSCs) for therapy relies on toxic Dimethyl Sulfoxide (Me2SO), posing safety risks. Developing safer, alternative methods is crucial for effective off-the-shelf iPSC treatments.

Area of Science:

  • Stem Cell Biology
  • Regenerative Medicine
  • Cryobiology

Background:

  • Induced pluripotent stem cells (iPSCs) hold immense therapeutic promise for various diseases.
  • Current clinical and preclinical iPSC therapies heavily depend on cryopreservation for storage and logistics.
  • Dimethyl Sulfoxide (Me2SO) is the standard cryoprotective agent but presents toxicity concerns.

Purpose of the Study:

  • To review current cryopreservation methods for iPSCs in therapeutic applications.
  • To identify challenges associated with Me2SO-based cryopreservation and post-thaw processing.
  • To emphasize the need for novel, safer cryopreservation strategies for iPSC therapies.

Main Methods:

  • Comprehensive literature review of iPSC cryopreservation techniques.
  • Analysis of cryopreservation protocols used in clinical and preclinical iPSC-based studies.
  • Evaluation of the impact of Me2SO on iPSC viability and function post-thaw.

Main Results:

  • Consistent utilization of Me2SO across existing iPSC cryopreservation protocols was observed.
  • Significant logistical hurdles in post-thaw processing of cryopreserved iPSCs were identified.
  • The inherent cytotoxicity of Me2SO remains a major concern for clinical translation.

Conclusions:

  • Current Me2SO-dependent cryopreservation methods pose risks to iPSC safety and therapeutic efficacy.
  • Alternative, non-toxic cryopreservation techniques are urgently required.
  • Advancing cryobiology is essential for realizing the full potential of off-the-shelf iPSC therapies.
Keywords:
DMSO‐freecell therapycryopreservationprocess developmentiPSC

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