Literature DB >> 23480951

Manufacturing mesenchymal stromal cells for phase I clinical trials.

Patrick J Hanley1, 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.   

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.
Copyright © 2013 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

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Year:  2013        PMID: 23480951      PMCID: PMC3611961          DOI: 10.1016/j.jcyt.2012.09.007

Source DB:  PubMed          Journal:  Cytotherapy        ISSN: 1465-3249            Impact factor:   5.414


  26 in total

1.  Simultaneous expansion and harvest of hematopoietic stem cells and mesenchymal stem cells derived from umbilical cord blood.

Authors:  Song Kedong; Fan Xiubo; Liu Tianqing; Hugo M Macedo; Jiang LiLi; Fang Meiyun; Shi Fangxin; Ma Xuehu; Cui Zhanfeng
Journal:  J Mater Sci Mater Med       Date:  2010-10-06       Impact factor: 3.896

2.  Toward closed-system culture of blood origin endothelial cells.

Authors:  Stephen J Wagner; Andrew C Myrup
Journal:  Transfusion       Date:  2005-07       Impact factor: 3.157

3.  The cultivation of human multipotent mesenchymal stromal cells in clinical grade medium for bone tissue engineering.

Authors:  Robert Pytlík; David Stehlík; Tomás Soukup; Marie Kalbácová; Frantisek Rypácek; Tomás Trc; Katarína Mulinková; Petra Michnová; Linda Kideryová; Jan Zivný; Pavel Klener; Romana Veselá; Marek Trnený; Pavel Klener
Journal:  Biomaterials       Date:  2009-04-10       Impact factor: 12.479

4.  Evaluation of senescence in mesenchymal stem cells isolated from equine bone marrow, adipose tissue, and umbilical cord tissue.

Authors:  Martin A Vidal; Naomi J Walker; Eleonora Napoli; Dori L Borjesson
Journal:  Stem Cells Dev       Date:  2011-05-06       Impact factor: 3.272

5.  Animal serum-free culture conditions for isolation and expansion of multipotent mesenchymal stromal cells from human BM.

Authors:  I Müller; S Kordowich; C Holzwarth; C Spano; G Isensee; A Staiber; S Viebahn; F Gieseke; H Langer; M P Gawaz; E M Horwitz; P Conte; R Handgretinger; M Dominici
Journal:  Cytotherapy       Date:  2006       Impact factor: 5.414

6.  Transplantability and therapeutic effects of bone marrow-derived mesenchymal cells in children with osteogenesis imperfecta.

Authors:  E M Horwitz; D J Prockop; L A Fitzpatrick; W W Koo; P L Gordon; M Neel; M Sussman; P Orchard; J C Marx; R E Pyeritz; M K Brenner
Journal:  Nat Med       Date:  1999-03       Impact factor: 53.440

7.  Translating research into clinical scale manufacturing of mesenchymal stromal cells.

Authors:  Karen Bieback; Sven Kinzebach; Marianna Karagianni
Journal:  Stem Cells Int       Date:  2011-01-20       Impact factor: 5.443

8.  Isolated allogeneic bone marrow-derived mesenchymal cells engraft and stimulate growth in children with osteogenesis imperfecta: Implications for cell therapy of bone.

Authors:  Edwin M Horwitz; Patricia L Gordon; Winston K K Koo; Jeffrey C Marx; Michael D Neel; Rene Y McNall; Linda Muul; Ted Hofmann
Journal:  Proc Natl Acad Sci U S A       Date:  2002-06-25       Impact factor: 11.205

9.  Culture and Use of Mesenchymal Stromal Cells in Phase I and II Clinical Trials.

Authors:  Bourin Philippe; Sensebé Luc; Planat-Bénard Valérie; Roncalli Jérôme; Bura-Rivière Alessandra; Casteilla Louis
Journal:  Stem Cells Int       Date:  2010-10-31       Impact factor: 5.443

10.  Mesenchymal stem cells.

Authors:  A I Caplan
Journal:  J Orthop Res       Date:  1991-09       Impact factor: 3.494

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  18 in total

1.  An update from the United States National Heart, Lung, and Blood Institute-funded Production Assistance for Cellular Therapies (PACT) program: a decade of cell therapy.

Authors:  Deborah Wood; Robin Wesselschmidt; Peiman Hematti; Adrian P Gee; Cliona Rooney; Leslie Silberstein; Myriam Armant; Larry Couture; John E Wagner; David H McKenna; Derek Hei; Traci Heath Mondoro; Lisbeth Welniak; Robert Lindblad
Journal:  Clin Transl Sci       Date:  2014-03-21       Impact factor: 4.689

Review 2.  Overcoming Challenges in Process Development of Cellular Therapies.

Authors:  Steven L Highfill; David F Stroncek
Journal:  Curr Hematol Malig Rep       Date:  2019-08       Impact factor: 3.952

3.  Soluble matrix protein is a potent modulator of mesenchymal stem cell performance.

Authors:  Giselle C Yeo; Anthony S Weiss
Journal:  Proc Natl Acad Sci U S A       Date:  2019-01-18       Impact factor: 11.205

Review 4.  Our Fat Future: Translating Adipose Stem Cell Therapy.

Authors:  Rachel C Nordberg; Elizabeth G Loboa
Journal:  Stem Cells Transl Med       Date:  2015-07-16       Impact factor: 6.940

5.  Efficient manufacturing of therapeutic mesenchymal stromal cells with the use of the Quantum Cell Expansion System.

Authors:  Patrick J Hanley; Zhuyong Mei; April G Durett; Maria da Graca Cabreira-Hansen; Marie da Graca Cabreira-Harrison; Mariola Klis; Wei Li; Yali Zhao; Bing Yang; Kaushik Parsha; Osman Mir; Farhaan Vahidy; Debra Bloom; R Brent Rice; Peiman Hematti; Sean I Savitz; Adrian P Gee
Journal:  Cytotherapy       Date:  2014-04-13       Impact factor: 5.414

6.  Predifferentiated Gingival Stem Cell-Induced Bone Regeneration in Rat Alveolar Bone Defect Model.

Authors:  Umadevi Kandalam; Toshihisa Kawai; Geeta Ravindran; Ross Brockman; Jorge Romero; Matthew Munro; Julian Ortiz; Alireza Heidari; Ron Thomas; Sajish Kuriakose; Christopher Naglieri; Shaileen Ejtemai; Steven I Kaltman
Journal:  Tissue Eng Part A       Date:  2020-09-18       Impact factor: 3.845

7.  Optimizing the production of suspension cells using the G-Rex "M" series.

Authors:  Pradip Bajgain; Roopa Mucharla; John Wilson; Dan Welch; Usanarat Anurathapan; Bitao Liang; Xiaohua Lu; Kyle Ripple; John M Centanni; Christine Hall; David Hsu; Larry A Couture; Shubhranshu Gupta; Adrian P Gee; Helen E Heslop; Ann M Leen; Cliona M Rooney; Juan F Vera
Journal:  Mol Ther Methods Clin Dev       Date:  2014-05-14       Impact factor: 6.698

8.  Purified Human Synovium Mesenchymal Stem Cells as a Good Resource for Cartilage Regeneration.

Authors:  Yusuke Ogata; Yo Mabuchi; Mayu Yoshida; Eriko Grace Suto; Nobuharu Suzuki; Takeshi Muneta; Ichiro Sekiya; Chihiro Akazawa
Journal:  PLoS One       Date:  2015-06-08       Impact factor: 3.240

Review 9.  Prospects for therapeutic tolerance in humans.

Authors:  Kenneth F Baker; John D Isaacs
Journal:  Curr Opin Rheumatol       Date:  2014-03       Impact factor: 5.006

Review 10.  Bioprocessing strategies for the large-scale production of human mesenchymal stem cells: a review.

Authors:  Krishna M Panchalingam; Sunghoon Jung; Lawrence Rosenberg; Leo A Behie
Journal:  Stem Cell Res Ther       Date:  2015-11-23       Impact factor: 6.832

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