Comparison of clinical grade human platelet lysates for cultivation of mesenchymal stromal cells from bone marrow and adipose tissue

References

• Baer PC, Geiger H. Adipose-derived mesenchymal stromal/stem cells: tissue localization, characterization, and heterogeneity. Stem Cells Int 2012;2012:812693.
   PubMed Web of Science ®Google Scholar
• Wei X, Yang X, Han Z, Qu F, Shao L, Shi Y. Mesenchymal stem cells: a new trend for cell therapy. Acta Pharmacol Sin 2013;34:747–54.
   PubMed Web of Science ®Google Scholar
• Sharma RR, Pollock K, Hubel A, McKenna D. Mesenchymal stem or stromal cells: a review of clinical applications and manufacturing practices. Transfusion 2014;54: 1418–37.
   PubMed Web of Science ®Google Scholar
• Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev 2011;20:1297–308.
   PubMed Web of Science ®Google Scholar
• Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res 2007;100: 1249–60.
   PubMed Web of Science ®Google Scholar
• Hourd P, Ginty P, Chandra A, Williams DJ. Manufacturing models permitting roll out/scale out of clinically led autologous cell therapies: regulatory and scientific challenges for comparability. Cytotherapy 2014;16:1033–47.
   PubMed Web of Science ®Google Scholar
• Fekete N, Rojewski MT, Fürst D, Kreja L, Ignatius A, Dausend J, Schrezenmeier H. GMP-compliant isolation and large-scale expansion of bone marrow-derived MSC. PLoS One 2012;7:e43255.
   PubMed Web of Science ®Google Scholar
• Muller I, Kordowich S, Holzwarth C, Spano C, Isensee G, Staiber A, Viebahn S, Gieseke F, Langer H, Gawaz MP, Horwitz EM, Conte P, Handgretinger R, Dominici M. Animal serum-free culture conditions for isolation and expansion of multipotent mesenchymal stromal cells from human BM. Cytotherapy 2006;8:437–44.
   PubMed Web of Science ®Google Scholar
• Perez-Ilzarbe M, Diez-Campelo M, Aranda P, Tabera S, Lopez T, del CC, Merino J, Moreno C, Andreu EJ, Prosper F, Perez-Simon JA. Comparison of ex vivo expansion culture conditions of mesenchymal stem cells for human cell therapy. Transfusion 2009;49:1901–10.
   PubMed Web of Science ®Google Scholar
• Bieback K. Platelet lysate as replacement for fetal bovine serum in mesenchymal stromal cell cultures. Transfus Med Hemother 2013;40:326–35.
   PubMed Web of Science ®Google Scholar
• Halme DG, Kessler DA. FDA regulation of stem-cell-based therapies. N Engl J Med 2006;355:1730–5.
   PubMed Web of Science ®Google Scholar
• Brunner D, Frank J, Appl H, Schöffl H, Pfaller W, Gstraunthaler G. Serum-free cell culture: the serum-free media interactive online database. ALTEX 2010;27:53–62.
   PubMedGoogle Scholar
• Lange C, Cakiroglu F, Spiess AN, Cappallo-Obermann H, Dierlamm J, Zander AR. Accelerated and safe expansion of human mesenchymal stromal cells in animal serum-free medium for transplantation and regenerative medicine. J.Cell Physiol 2007;213:18–26.
   PubMed Web of Science ®Google Scholar
• Chase LG, Yang S, Zachar V, Yang Z, Lakshmipathy U, Bradford J, Boucher SE, Vemuri MC. Development and characterization of a clinically compliant xeno-free culture medium in good manufacturing practice for human multipotent mesenchymal stem cells. Stem Cells Transl Med 2012;1:750–8.
   Web of Science ®Google Scholar
• Froud SJ. The development, benefits and disadvantages of serum-free media. Dev Biol Stand 1999;99:157–66.
   PubMedGoogle Scholar
• Gstraunthaler G. Alternatives to the use of fetal bovine serum: serum-free cell culture. ALTEX 2003;20:275–81.
   PubMedGoogle Scholar
• Hemeda H, Giebel B, Wagner W. Evaluation of human platelet lysate versus fetal bovine serum for culture of mesenchymal stromal cells. Cytotherapy 2014;16:170–80.
   PubMed Web of Science ®Google Scholar
• Shih DTB, Burnouf T. Preparation, quality criteria, and properties of human blood platelet lysate supplements for ex vivo stem cell expansion. N Biotechnol 2014:199–211.
   PubMed Web of Science ®Google Scholar
• Bernardi M, Albiero E, Alghisi A, Chieregato K, Lievore C, Madeo D, Rodeghiero F, Astori G. Production of human platelet lysate by use of ultrasound for ex vivo expansion of human bone marrow-derived mesenchymal stromal cells. Cytotherapy 2013:920–9.
   PubMed Web of Science ®Google Scholar
• Bieback K, Hecker A, Kocaomer A, Lannert H, Schallmoser K, Strunk D, Kluter H. Human alternatives to fetal bovine serum for the expansion of mesenchymal stromal cells from bone marrow. Stem Cells 2009;27:2331–41.
   PubMed Web of Science ®Google Scholar
• Trojahn Kolle SF, Oliveri RS, Glovinski PV, Kirchhoff M, Mathiasen AB, Elberg JJ, Andersen PS, Drzewiecki KT, Fischer-Nielsen A. Pooled human platelet lysate versus fetal bovine serum-investigating the proliferation rate, chromosome stability and angiogenic potential of human adipose tissue-derived stem cells intended for clinical use. Cytotherapy 2013;15:1086–97.
   PubMed Web of Science ®Google Scholar
• Haack-Sørensen M, Friis T, Mathiasen AB, Jørgensen E, Hansen L, Dickmeiss E, Ekblond A, Kastrup J. Direct intramyocardial mesenchymal stromal cell injections in patients with severe refractory angina: one-year follow-up. Cell Transplant 2013;22:521–8.
   PubMed Web of Science ®Google Scholar
• Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng 2001;7:211–28.
   PubMedGoogle Scholar
• Bourin P, Bunnell BA, Casteilla L, Dominici M, Katz AJ, March KL, Redl H, Rubin JP, Yoshimura K, Gimble JM. Stromal cells from the adipose tissue-derived stromal vascular fraction and culture expanded adipose tissue-derived stromal/stem cells: a joint statement of the International Federation for Adipose Therapeutics and Science (IFATS) and the International Society for Cellular Therapy (ISCT). Cytotherapy 2013;15:641–8.
   PubMed Web of Science ®Google Scholar
• Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop D, Horwitz E. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy 2006;8:315–17.
   PubMed Web of Science ®Google Scholar
• Krampera M, Galipeau J, Shi Y, Tarte K, Sensebe L. Immunological characterization of multipotent mesenchymal stromal cells. The International Society for Cellular Therapy (ISCT) working proposal. Cytotherapy 2013;15: 1054–61.
   PubMed Web of Science ®Google Scholar
• Menard C, Pacelli L, Bassi G, Dulong J, Bifari F, Bezier I, Zanoncello J, Ricciardi M, Latour M, Bourin P, Schrezenmeier H, Sensebe L, Tarte K, Krampera M. Clinical-grade mesenchymal stromal cells produced under various good manufacturing practice processes differ in their immunomodulatory properties: standardization of immune quality controls. Stem Cells Dev 2013;22:1789–801.
   PubMed Web of Science ®Google Scholar
• Mannello F, Tonti GA. Concise review: no breakthroughs for human mesenchymal and embryonic stem cell culture: conditioned medium, feeder layer, or feeder-free; medium with fetal calf serum, human serum, or enriched plasma; serum-free, serum replacement nonconditioned medium, or ad hoc formula? All that glitters is not gold! Stem Cells 2007;25:1603–9.
   PubMed Web of Science ®Google Scholar
• Bieback K, Kinzebach S, Karagianni M. Translating research into clinical scale manufacturing of mesenchymal stromal cells. Stem Cells Int 2011;2010:193519.
   PubMedGoogle Scholar
• Haack-Sørensen M, Hansen SK, Hansen L, Gaster M, Hyttel P, Ekblond A, Kastrup J. Mesenchymal stromal cell phenotype is not influenced by confluence during culture expansion. Stem Cell Rev 2013;9:44–58.
   PubMed Web of Science ®Google Scholar
• Kolle SF, Fischer-Nielsen A, Mathiasen AB, Elberg JJ, Oliveri RS, Glovinski PV, Kastrup J, Kirchhoff M, Rasmussen BS, Talman ML, Thomsen C, Dickmeiss E, Drzewiecki KT. Enrichment of autologous fat grafts with ex-vivo expanded adipose tissue-derived stem cells for graft survival: a randomised placebo-controlled trial. Lancet 2013;382:1113–20.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. EMA/CHMP/BWP/457920/2012: Guideline on the use of bovine serum in the manufacture of human biological medicinal products.
   Google Scholar
• Muller AM, Davenport M, Verrier S, Droeser R, Alini M, Bocelli-Tyndall C, Schaefer DJ, Martin I, Scherberich A. Platelet lysate as a serum substitute for 2D static and 3D perfusion culture of stromal vascular fraction cells from human adipose tissue. Tissue Eng Part A 2009;15:869–75.
   PubMed Web of Science ®Google Scholar
• McIntosh K, Zvonic S, Garrett S, Mitchell JB, Floyd ZE, Hammill L, Kloster A, Di HY, Ting JP, Storms RW, Goh B, Kilroy G, Wu X, Gimble JM. The immunogenicity of human adipose-derived cells: temporal changes in vitro. Stem Cells 2006;24:1246–53.
   PubMed Web of Science ®Google Scholar
• Yoshimura K, Shigeura T, Matsumoto D, Sato T, Takaki Y, Aiba-Kojima E, Sato K, Inoue K, Nagase T, Koshima I, Gonda K. Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirates. J Cell Physiol 2006;208:64–76.
   PubMed Web of Science ®Google Scholar
• Varma MJ, Breuls RG, Schouten TE, Jurgens WJ, Bontkes HJ, Schuurhuis GJ, van Ham SM, van Milligen FJ. Phenotypical and functional characterization of freshly isolated adipose tissue-derived stem cells. Stem Cells Dev 2007;16:91–104.
   PubMed Web of Science ®Google Scholar
• Strem BM, Hicok KC, Zhu M, Wulur I, Alfonso Z, Schreiber RE, Fraser JK, Hedrick MH. Multipotential differentiation of adipose tissue-derived stem cells. Keio J Med 2005;54:132–41.
   PubMed Web of Science ®Google Scholar
• Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science 1999;284:143–7.
   PubMed Web of Science ®Google Scholar
• Parker A, Shang H, Khurgel M, Katz A. Low serum and serum-free culture of multipotential human adipose stem cells. Cytotherapy 2007;9:637–46.
   PubMed Web of Science ®Google Scholar
• Haack-Sørensen M, Friis T, Bindslev L, Mortensen S, Johnsen HE, Kastrup J. Comparison of different culture conditions for human mesenchymal stromal cells for clinical stem cell therapy. Scand J Clin Lab Invest 2008;68:192–203.
   PubMed Web of Science ®Google Scholar
• Mizuno N, Shiba H, Ozeki Y, Mouri Y, Niitani M, Inui T, Hayashi H, Suzuki K, Tanaka S, Kawaguchi H, Kurihara H. Human autologous serum obtained using a completely closed bag system as a substitute for foetal calf serum in human mesenchymal stem cell cultures. Cell Biol Int 2006;30:521–4.
   PubMed Web of Science ®Google Scholar
• Nimura A, Muneta T, Koga H, Mochizuki T, Suzuki K, Makino H, Umezawa A, Sekiya I. Increased proliferation of human synovial mesenchymal stem cells with autologous human serum: comparisons with bone marrow mesenchymal stem cells and with fetal bovine serum. Arthritis Rheum 2008;58:501–10.
   PubMed Web of Science ®Google Scholar
• Shahdadfar A, Fronsdal K, Haug T, Reinholt FP, Brinchmann JE. In vitro expansion of human mesenchymal stem cells: choice of serum is a determinant of cell proliferation, differentiation, gene expression, and transcriptome stability. Stem Cells 2005;23:1357–66.
   PubMed Web of Science ®Google Scholar