title: Manufacturing mesenchymal stromal cells for phase I clinical trials.
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.
authors.affiliation: Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and The Methodist Hospital, Houston, TX, USA. pxhanley@txch.org
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Hanley
authors.forename: Zhuyong
authors.initials: Z
authors.lastname: Mei
authors.forename: Maria
authors.initials: M
authors.lastname: da Graca Cabreira-Hansen
authors.forename: Mariola
authors.initials: M
authors.lastname: Klis
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.forename: Yali
authors.initials: Y
authors.lastname: Zhao
authors.forename: April G
authors.initials: AG
authors.lastname: Durett
authors.forename: Xingwu
authors.initials: X
authors.lastname: Zheng
authors.forename: Yongping
authors.initials: Y
authors.lastname: Wang
authors.forename: Adrian P
authors.initials: AP
authors.lastname: Gee
authors.forename: Edwin M
authors.initials: EM
authors.lastname: Horwitz
mesh_terms: D001854:Bone Marrow Cells / Q000166:cytology*; D018929:Cell Culture Techniques / Q000379:methods*; D002454:Cell Differentiation; D002478:Cells, Cultured; D017321:Clinical Trials, Phase I as Topic; D015925:Cryopreservation; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000166:cytology*; D045164:Mesenchymal Stem Cell Transplantation / Q000379:methods; D059630:Mesenchymal Stem Cells / Q000166:cytology*