Abstract
The Dideco 'Pluricell System' is a CE-marked medical device allowing haematopoietic stem cell (HSC) expansion. It comprises a kit of cGMP cytokines and reagents, a closed-cell expansion chamber and a cell-washing set. We tested the system in a multicentric study by expanding CD34(+) cells from eight fresh umbilical cord blood (UCB) samples. During culture, the mean nucleated cell (NC) count, the mean CD34(+) cell count, fold expansion, viability and apoptosis were measured. Clonogenic assays and immunophenotypical characterization were performed on days 0, 7 and 12. On the expanded cellular product, in three cases cell genotyping, endotoxin level and mycoplasma detection (by polymerase chain reaction) were performed. The mean CD34(+) cell expansion on days 7 and 12 was sevenfold and 12-fold respectively and the mean NC expansion was 69-fold and 180-fold. The mean NC viability on day 12 was 96.9% (94.4-99.1). After 12 days, granulocyte-macrophage colony-forming units (GM-CFU) showed a 20-fold increase: a slight increase in CD34(+) cell apoptosis was observed during culture. In all of three cases neither chromosomal alterations nor mycoplasma contamination was detected. No significant endotoxin levels were detected after expansio...Continue Reading
References
Aug 3, 1995·The New England Journal of Medicine·W BruggerL Kanz
Jun 1, 1996·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·M J AlcornI M Franklin
Jun 1, 1996·Journal of Hematotherapy·D R SutherlandI Chin-Yee
Apr 1, 1997·Journal of Hematotherapy·R A BriddellI K McNiece
Apr 24, 1999·Stem Cells·J A HunnestadT Egeland
Aug 24, 1999·Gene Therapy·K M MatsudaK Ozawa
Oct 6, 1999·Lancet·J ReiffersJ M Boiron
Oct 30, 1999·Human Gene Therapy·S Kochanek
Jan 25, 2000·Journal of Hematotherapy & Stem Cell Research·L QiuR H Herzig
Jul 17, 2001·Journal of Hematotherapy & Stem Cell Research·L Douay
Jul 21, 2001·Stem Cells·T RossmanithO G Ottmann
Sep 6, 2001·Bone Marrow Transplantation·A L PecoraR Preti
Apr 9, 2002·Experimental Hematology·Ronald L PaquetteJohn A Glaspy
Aug 13, 2002·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Elizabeth J ShpallIan K McNiece
Mar 7, 2003·Bone Marrow Transplantation·S M DevineS G Emerson
Nov 1, 2003·Blood·Dong-Wook KimIl-Hoan Oh
May 18, 2004·Experimental Hematology·Eliane Gluckman
May 18, 2004·Experimental Hematology·John E Wagner, Catherine M Verfaillie
Aug 4, 2004·British Journal of Haematology·H Miles PrinceDavid N Haylock
Oct 7, 2004·Blood·Juliet N BarkerJohn E Wagner
Dec 1, 2004·Vox Sanguinis·L RodríguezS Querol
Apr 12, 2005·Bone Marrow Transplantation·G AstoriA Degrassi
Citations
Apr 10, 2007·Annals of Biomedical Engineering·Xiubo FanZhanfeng Cui
Apr 1, 2009·Applied Biochemistry and Biotechnology·Mei ZhaoWei Han
Feb 20, 2008·Vox Sanguinis·D LorenzonG Astori
May 10, 2007·British Journal of Haematology·Yvonne K KwokElizabeth T Lau
Feb 16, 2008·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·J J NietfeldMary M Horowitz
Jan 28, 2012·Molecular BioSystems·David A Winkler, Frank R Burden