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Manufacturing mesenchymal stromal cells for phase I clinical trials
Authors:Patrick J. Hanley  Zhuyong Mei  Maria da Graca Cabreira-Hansen  Mariola Klis  Wei Li  Yali Zhao  April G. Durett  Xingwu Zheng  Yongping Wang  Adrian P. Gee  Edwin M. Horwitz
Affiliation:1. Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children''s Hospital and The Methodist Hospital, Houston, Texas, USA;2. The Texas Heart Institute, St Luke''s Episcopal Hospital, Houston, Texas, USA;3. The Children''s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA;4. The University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA;1. Tel Aviv Sourasky Medical Center, The Hematology and Bone Marrow Transplant Laboratory, Tel Aviv, Israel;2. The Evelyn H. Griffin and the Judith R. Hoffberger cGMP Facilities, Program of Regenerative Medicine/University of Texas, Houston, Texas, USA;3. Massachusetts General Hospital, Boston, Massachusetts, USA;1. Research and Development Unit, National Heart Centre Singapore, Singapore;2. Department of Cardiology, National Heart Centre Singapore, Singapore;1. Istituto di Ematologia, Università Cattolica Del Sacro Cuore, Rome, Italy;2. Unità di valutazione delle tecnologie, Università Cattolica Del Sacro Cuore, Rome, Italy
Abstract: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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