Journal
CYTOTHERAPY
Volume 15, Issue 4, Pages 416-422Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.jcyt.2012.09.007
Keywords
clinical trials; Good Manufacturing Practices; mesenchymal stromal cells; phase I trials
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Funding
- National Heart, Lung and Blood Institute-National Institutes of Health [HHSN268201000007C]
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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.
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