title: Isolation and Manufacture of Clinical-Grade Bone Marrow-Derived Human Mesenchymal Stromal Cells.
abstract: Mesenchymal stromal cells (MSCs) are multipotent cells with both regenerative and immunomodulatory capacities. These unique properties make them appealing as a biologic, with multiple phase 1-3 clinical trials currently testing their safety and efficacy. Although expanding MSCs does not require extensive manipulation, expanding MSCs for use in clinical trials does require the knowledge and safety that are delineated in current good manufacturing practices (GMPs). Here we briefly detail the characteristics of MSCs and considerations for expanding them for clinical use. We then include a step-by-step protocol for expanding MSCs for early phase clinical trials, with important notes to consider during the expansion of these MSCs.
authors.affiliation: Program for Cell Enhancement and Technologies for Immunotherapy, Center for Cancer and Immunology Research, Washington, DC, USA.|Children's National Health System, 111 Michigan Avenue, Washington, DC, 20010, USA.
authors.forename: Renuka P
authors.initials: RP
authors.lastname: Miller
authors.affiliation: Program for Cell Enhancement and Technologies for Immunotherapy, Center for Cancer and Immunology Research, Washington, DC, USA. phanley@childrensnational.org.|Children's National Health System, 111 Michigan Avenue, Washington, DC, 20010, USA. phanley@childrensnational.org.|Division of Blood and Marrow Transplantation, Washington, DC, USA. phanley@childrensnational.org.|Sheikh Zayed Institute for Pediatric Surgical Innovation, Washington, DC, USA. phanley@childrensnational.org.|The George Washington University, Washington, DC, USA. phanley@childrensnational.org.
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Hanley
mesh_terms: D018929:Cell Culture Techniques / Q000379:methods*; D002454:Cell Differentiation; D049109:Cell Proliferation; D002469:Cell Separation / Q000379:methods*; D002478:Cells, Cultured; D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D019983:Guideline Adherence; D006801:Humans; D016130:Immunophenotyping; D045164:Mesenchymal Stem Cell Transplantation; D059630:Mesenchymal Stem Cells / Q000166:cytology* / Q000276:immunology; D013048:Specimen Handling
keywords: Cell therapy; Clinical grade; Good manufacturing practices; Mesenchymal stromal cells