title: Generation of clinical grade human bone marrow stromal cells for use in bone regeneration.
abstract: In current orthopaedic practice, there is a need to increase the ability to reconstruct large segments of bone lost due to trauma, resection of tumors and skeletal deformities, or when normal regenerative processes have failed such as in non-unions and avascular necrosis. Bone marrow stromal cells (BMSCs, also known as bone marrow-derived mesenchymal stem cells), when used in conjunction with appropriate carriers, represent a means by which to achieve bone regeneration in such cases. While much has been done at the bench and in pre-clinical studies, moving towards clinical application requires the generation of clinical grade cells. What is described herein is an FDA-approved cell manufacturing procedure for the ex vivo expansion of high quality, biologically active human BMSCs. This article is part of a Special Issue entitled Stem Cells and Bone.
authors: Craniofacial and Skeletal Diseases Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA. Electronic address: probey@dir.nidcr.nih.gov.
authors: Pamela G
authors: PG
authors: Robey
authors: Craniofacial and Skeletal Diseases Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA.
authors: Sergei A
authors: SA
authors: Kuznetsov
authors: Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA; Cell Processing Section, Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA.
authors: Jiaqiang
authors: J
authors: Ren
authors: Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA.
authors: Harvey G
authors: HG
authors: Klein
authors: Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA; Cell Processing Section, Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA.
authors: Marianna
authors: M
authors: Sabatino
authors: Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA; Cell Processing Section, Department of Transfusion Medicine, Warren G. Magnuson Clinical Center, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA.
authors: David F
authors: DF
authors: Stroncek
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D019149:Bioreactors; D001861:Bone Regeneration; D018929:Cell Culture Techniques / Q000379:methods*; D049109:Cell Proliferation; D002478:Cells, Cultured; D006801:Humans; D045164:Mesenchymal Stem Cell Transplantation; D059630:Mesenchymal Stem Cells / Q000166:cytology*; D011786:Quality Control
chemical_list: D015415:Biomarkers
keywords: Bioreactor; Bone marrow stromal cells; Cell factories; Good manufacturing practices