Manufacturing mesenchymal stromal cells for phase I clinical trials

Cytotherapy. 2013 Apr;15(4):416-22. doi: 10.1016/j.jcyt.2012.09.007.


Mesenchymal stromal cells (MSCs) are multipotent progenitor cells capable of differentiating into adipocytes, osteoblasts and chondroblasts as well as secreting a vast array of soluble mediators. This potentially makes MSCs important mediators of a variety of therapeutic applications. They are actively under evaluation for immunomodulatory purposes such as graft-versus-host disease and Crohn's disease as well as regenerative applications such as stroke and congestive heart failure. We report our method of generating clinical-grade MSCs together with suggestions gathered from manufacturing experience in our Good Manufacturing Practices facility.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Bone Marrow Cells / cytology*
  • Cell Culture Techniques / methods*
  • Cell Differentiation
  • Cells, Cultured
  • Clinical Trials, Phase I as Topic
  • Cryopreservation
  • Humans
  • Leukocytes, Mononuclear / cytology*
  • Mesenchymal Stem Cell Transplantation / methods
  • Mesenchymal Stem Cells / cytology*