메뉴 건너뛰기




Volumn 13, Issue 7, 2011, Pages 848-855

Guidelines for the development and validation of new potency assays for the evaluation of umbilical cord blood

Author keywords

Umbilical cord blood banking; Umbilical cord blood potency assessment; Umbilical cord blood processing; Umbilical cord blood transplantation

Indexed keywords

ARTICLE; ASSAY; CELL THERAPY; EVALUATION; HUMAN; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; TECHNIQUE; UMBILICAL CORD BLOOD; VALIDATION PROCESS;

EID: 84860389700     PISSN: 14653249     EISSN: 14772566     Source Type: Journal    
DOI: 10.3109/14653249.2011.571249     Document Type: Article
Times cited : (26)

References (42)
  • 1
    • 0024396816 scopus 로고
    • Hematopoietic reconstitution in a patient with Fanconi's anemia by means of umbilicalcord blood from an HLA-identical sibling
    • Gluckman E, Broxmeyer HA, Auerbach AD, Friedman HS, Douglas GW, Devergie A, et al. Hematopoietic reconstitution in a patient with Fanconi's anemia by means of umbilicalcord blood from an HLA-identical sibling. N Engl J Med. 1989;321:1174-8.
    • (1989) N Engl J Med , vol.321 , pp. 1174-1178
    • Gluckman, E.1    Broxmeyer, H.A.2    Auerbach, A.D.3    Friedman, H.S.4    Douglas, G.W.5    Devergie, A.6
  • 2
    • 0029742950 scopus 로고    scopus 로고
    • Successful transplantation of HLAmatched and HLA-mismatched umbilical cord blood from unrelated donors: Analysis of engraftment and acute graftversus- host disease
    • Wagner JE, Rosenthal J, Sweetman R, Shu XO, Davies SM, Ramsay NK, et al. Successful transplantation of HLAmatched and HLA-mismatched umbilical cord blood from unrelated donors: Analysis of engraftment and acute graftversus- host disease. Blood. 1996;88:795-802.
    • (1996) Blood , vol.88 , pp. 795-802
    • Wagner, J.E.1    Rosenthal, J.2    Sweetman, R.3    Shu, X.O.4    Davies, S.M.5    Ramsay, N.K.6
  • 3
    • 8944228913 scopus 로고    scopus 로고
    • Placental blood as a source of hematopoietic stem cells for transplantation into unrelated recipients
    • Kurtzberg J, Laughlin M, Graham ML, Smith C, Olson JF, Halperin EC, et al. Placental blood as a source of hematopoietic stem cells for transplantation into unrelated recipients. N Engl J Med. 1996;335:157-66.
    • (1996) N Engl J Med , vol.335 , pp. 157-166
    • Kurtzberg, J.1    Laughlin, M.2    Graham, M.L.3    Smith, C.4    Olson, J.F.5    Halperin, E.C.6
  • 4
    • 0030592103 scopus 로고    scopus 로고
    • Cord-blood transplantation from an unrelated donor in an adult with chronic myelogenous leukemia
    • Laporte JP, Gorin NC, Rubinstein P, Lesage S, Portnoi MF, Barbu V, et al. Cord-blood transplantation from an unrelated donor in an adult with chronic myelogenous leukemia. N Engl J Med. 1996;335:167-70.
    • (1996) N Engl J Med , vol.335 , pp. 167-170
    • Laporte, J.P.1    Gorin, N.C.2    Rubinstein, P.3    Lesage, S.4    Portnoi, M.F.5    Barbu, V.6
  • 5
    • 72449162691 scopus 로고    scopus 로고
    • Umbilical cord transplantation: Epilogue
    • Broxmeyer HE. Umbilical cord transplantation: Epilogue. Semin Hematol. 2010;47:97-103.
    • (2010) Semin Hematol , vol.47 , pp. 97-103
    • Broxmeyer, H.E.1
  • 6
    • 77953044213 scopus 로고    scopus 로고
    • New approaches for improving engraftment after cord blood transplantation
    • Rocha V, Broxmeyer HE. New approaches for improving engraftment after cord blood transplantation. Biol Blood Marrow Transplant. 2010;16:S126-32.
    • (2010) Biol Blood Marrow Transplant , vol.16
    • Rocha, V.1    Broxmeyer, H.E.2
  • 7
    • 0027880137 scopus 로고
    • Placental blood-derived hematopoietic stem cells for unrelated bone marrow reconstitution
    • Rubinstein P. Placental blood-derived hematopoietic stem cells for unrelated bone marrow reconstitution. J Hematother. 1993;2:207-10.
    • (1993) J Hematother , vol.2 , pp. 207-210
    • Rubinstein, P.1
  • 8
    • 0027470021 scopus 로고
    • Stored placental blood for unrelated bone marrow reconstitution
    • Rubinstein P, Rosenfi eld RE, Adamson JW, Stevens CE. Stored placental blood for unrelated bone marrow reconstitution. Blood. 1993;81:1679-90.
    • (1993) Blood , vol.81 , pp. 1679-1690
    • Rubinstein, P.1    Rosenfield, R.E.2    Adamson, J.W.3    Stevens, C.E.4
  • 12
    • 77954031042 scopus 로고    scopus 로고
    • Effect of graft source on unrelated donor haemopoietic stem-cell transplantation in adults with acute leukaemia: A retrospective analysis
    • Eapen M, Rocha V, Sanz G, Scaradavou A, Zhang MJ, Arcese W, et al. Effect of graft source on unrelated donor haemopoietic stem-cell transplantation in adults with acute leukaemia: A retrospective analysis. Lancet Oncol. 2010;11:653-60.
    • (2010) Lancet Oncol , vol.11 , pp. 653-660
    • Eapen, M.1    Rocha, V.2    Sanz, G.3    Scaradavou, A.4    Zhang, M.J.5    Arcese, W.6
  • 13
    • 34249899377 scopus 로고    scopus 로고
    • Outcomes of transplantation of unrelated donor umbilical cord blood and bone marrow in children with acute leukaemia: A comparison study
    • Eapen M, Rubinstei P, Zhang MJ, Stevens C, Kurtzberg J, Scaradavou A, et al. Outcomes of transplantation of unrelated donor umbilical cord blood and bone marrow in children with acute leukaemia: A comparison study. Lancet 2007;369:1947-54.
    • (2007) Lancet , vol.369 , pp. 1947-1954
    • Eapen, M.1    Rubinstei, P.2    Zhang, M.J.3    Stevens, C.4    Kurtzberg, J.5    Scaradavou, A.6
  • 14
    • 20444424482 scopus 로고    scopus 로고
    • Characterization of banked umbilical cord blood hematopoietic progenitor cells and lymphocyte subsets and correlation with ethnicity, birth weight, sex, and type of delivery: A Cord Blood Transplantation (COBLT) study report
    • Cairo MS, Wagner EL, Fraser J, Cohen G, van de Ven C, Carter SL, et al. Characterization of banked umbilical cord blood hematopoietic progenitor cells and lymphocyte subsets and correlation with ethnicity, birth weight, sex, and type of delivery: A Cord Blood Transplantation (COBLT) study report. Transfusion. 2005;45:856-66.
    • (2005) Transfusion , vol.45 , pp. 856-866
    • Cairo, M.S.1    Wagner, E.L.2    Fraser, J.3    Cohen, G.4    Van De Ven, C.5    Carter, S.L.6
  • 15
    • 33846487365 scopus 로고    scopus 로고
    • Morphological and molecular characterization of novel population of CXCR4+ SSEA-4+ Oct-4+ very small embryonic-like cells purifi ed from human cord blood: Preliminary report
    • Kucia M, Halasa M, Wysoczynski M, Baskiewicz-Masiuk M, Moldenhawer S, Zuba-Surma E, et al. Morphological and molecular characterization of novel population of CXCR4+ SSEA-4+ Oct-4+ very small embryonic-like cells purifi ed from human cord blood: Preliminary report. Leukemia. 2007; 21:297-303.
    • (2007) Leukemia , vol.21 , pp. 297-303
    • Kucia, M.1    Halasa, M.2    Wysoczynski, M.3    Baskiewicz-Masiuk, M.4    Moldenhawer, S.5    Zuba-Surma, E.6
  • 16
    • 72449147311 scopus 로고    scopus 로고
    • Optimization of isolation and further characterization of umbilical-cord-blood-derived very small embryonic/ epiblast-like stem cells (VSELs)
    • Zuba-Surma EK, Klich I, Greco N, Laughlin MJ, Ratajczak J, Ratajczak MZ. Optimization of isolation and further characterization of umbilical-cord-blood- derived very small embryonic/ epiblast-like stem cells (VSELs). Eur J Haematol. 2010;84: 34-46.
    • (2010) Eur J Haematol , vol.84 , pp. 34-46
    • Zuba-Surma, E.K.1    Klich, I.2    Greco, N.3    Laughlin, M.J.4    Ratajczak, J.5    Ratajczak, M.Z.6
  • 17
    • 0037457890 scopus 로고    scopus 로고
    • High-effi ciency recovery of functional hematopoietic progenitor and stem cells from human cord blood cryopreserved for 15 years
    • Broxmeyer HE, Srour EF, Hangoc G, Cooper S, Anderson SA, Bodine DM. High-effi ciency recovery of functional hematopoietic progenitor and stem cells from human cord blood cryopreserved for 15 years. Proc Natl Acad Sci USA. 2003;100:645-50.
    • (2003) Proc Natl Acad Sci USA , vol.100 , pp. 645-650
    • Broxmeyer, H.E.1    Srour, E.F.2    Hangoc, G.3    Cooper, S.4    Anderson, S.A.5    Bodine, D.M.6
  • 18
    • 84879120388 scopus 로고    scopus 로고
    • Center for Biologics Evaluation and Research, Rockville, MD. Minimally Manipulated, Unrelated Allogeneic Placental/ Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specifi ed Indications. FDA Guidance for Industry. US Department of Health and Human Services, Food and Drug Administration; Accessed date: 14 April 2010
    • Center for Biologics Evaluation and Research, Rockville, MD. Minimally Manipulated, Unrelated Allogeneic Placental/ Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specifi ed Indications. FDA Guidance for Industry. US Department of Health and Human Services, Food and Drug Administration; 2009. http://www.fda.gov/downloads/ BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/ Guidances/Blood/UCM187146.pdf. Accessed date: 14 April 2010.
    • (2009)
  • 19
    • 85031231184 scopus 로고    scopus 로고
    • NetCord-FACT Omaha NE. International Standards for Cord Blood Collection Banking and Release for Administration. 4th ed. NetCord-FACT Accessed date: 14 April 2010
    • NetCord-FACT, Omaha, NE. International Standards for Cord Blood Collection, Banking, and Release for Administration. 4th ed. NetCord-FACT; 2010. http://www.factwebsite. org/uploadedFiles/News/4th-Edition-Cord-Blood- Standards-4.0.pdf. Accessed date: 14 April 2010.
    • (2010)
  • 20
    • 0037243664 scopus 로고    scopus 로고
    • Long term cryostorage of UC blood units: Ability of the integral segment to confi rm both identity and hematopoietic potential
    • Goodwin HS, Grunzinger LM, Regan DM, McCormick KA, Johnson CE, Oliver DA, et al. Long term cryostorage of UC blood units: Ability of the integral segment to confi rm both identity and hematopoietic potential. Cytotherapy. 2003;5:80-6.
    • (2003) Cytotherapy , vol.5 , pp. 80-86
    • Goodwin, H.S.1    Grunzinger, L.M.2    Regan, D.M.3    McCormick, K.A.4    Johnson, C.E.5    Oliver, D.A.6
  • 21
    • 16244404652 scopus 로고    scopus 로고
    • Predictive utility of the attached segment in the quality control of a cord blood graft
    • Rodriguez L, Garcia J, Querol S. Predictive utility of the attached segment in the quality control of a cord blood graft. Biol Blood Marrow Transplant. 2005;11:247-51.
    • (2005) Biol Blood Marrow Transplant , vol.11 , pp. 247-251
    • Rodriguez, L.1    Garcia, J.2    Querol, S.3
  • 22
    • 0036786949 scopus 로고    scopus 로고
    • Placental/umbilical cord blood for unrelateddonor bone marrow reconstitution: Relevance of nucleated red blood cells
    • Stevens CE, Gladstone J, Taylor PE, Scaradavou A, Migliaccio AR, Visser J, et al. Placental/umbilical cord blood for unrelateddonor bone marrow reconstitution: Relevance of nucleated red blood cells. Blood. 2002;100:2662-4.
    • (2002) Blood , vol.100 , pp. 2662-2664
    • Stevens, C.E.1    Gladstone, J.2    Taylor, P.E.3    Scaradavou, A.4    Migliaccio, A.R.5    Visser, J.6
  • 23
    • 0031646733 scopus 로고    scopus 로고
    • Anti-CD34+ Fabs generated against hematopoietic stem cells in HIV-derived combinatorial immunoglobulin library suggest antigen-selected autoantibodies
    • Rubinstein DB, Leblanc P, Wright DG, Guillaume T, Strotchevoi A, Boosalis M. Anti-CD34+ Fabs generated against hematopoietic stem cells in HIV-derived combinatorial immunoglobulin library suggest antigen-selected autoantibodies. Mol Immunol. 1998;35:955-64.
    • (1998) Mol Immunol , vol.35 , pp. 955-964
    • Rubinstein, D.B.1    Leblanc, P.2    Wright, D.G.3    Guillaume, T.4    Strotchevoi, A.5    Boosalis, M.6
  • 24
    • 0034667625 scopus 로고    scopus 로고
    • Cell dose and speed of engraftment in placental/umbilical cord blood transplantation: Graft progenitor cell content is a better predictor than nucleated cell quantity
    • Migliaccio AR, Adamson JW, Stevens CE, Dobrila NL, Carrier CM, Rubinstein P. Cell dose and speed of engraftment in placental/umbilical cord blood transplantation: Graft progenitor cell content is a better predictor than nucleated cell quantity. Blood. 2000;96:2717-22.
    • (2000) Blood , vol.96 , pp. 2717-2722
    • Migliaccio, A.R.1    Adamson, J.W.2    Stevens, C.E.3    Dobrila, N.L.4    Carrier, C.M.5    Rubinstein, P.6
  • 25
    • 53449089638 scopus 로고    scopus 로고
    • Unrelated donor umbilical cord blood transplantation for inherited metabolic disorders in 159 pediatric patients from a single center: Infl uence of cellular composition of the graft on transplantation outcomes
    • Prasad VK, Mendizabal A, Parikh SH, Szabolcs P, Driscoll TA, Page K, et al. Unrelated donor umbilical cord blood transplantation for inherited metabolic disorders in 159 pediatric patients from a single center: Infl uence of cellular composition of the graft on transplantation outcomes. Blood. 2008;112:2979-89.
    • (2008) Blood , vol.112 , pp. 2979-2989
    • Prasad, V.K.1    Mendizabal, A.2    Parikh, S.H.3    Szabolcs, P.4    Driscoll, T.A.5    Page, K.6
  • 26
    • 77649339493 scopus 로고    scopus 로고
    • Cord blood units with low CD34+ cell viability have a low probability of engraftment after double unit transplantation
    • Scaradavou A, Smith KM, Hawke R, Schaible A, Abboud M, Kernan NA, et al. Cord blood units with low CD34+ cell viability have a low probability of engraftment after double unit transplantation. Biol Blood Marrow Transplant. 2010; 16:500-8.
    • (2010) Biol Blood Marrow Transplant , vol.16 , pp. 500-508
    • Scaradavou, A.1    Smith, K.M.2    Hawke, R.3    Schaible, A.4    Abboud, M.5    Kernan, N.A.6
  • 28
    • 33645289413 scopus 로고    scopus 로고
    • Multiple-laboratory comparison of in vitro assays utilized to characterize hematopoietic cells in cord blood
    • Moroff G, Eichler H, Brand A, Kekomaki R, Kurtz J, Letowska M, et al. Multiple-laboratory comparison of in vitro assays utilized to characterize hematopoietic cells in cord blood. Transfusion. 2006;46:507-15.
    • (2006) Transfusion , vol.46 , pp. 507-515
    • Moroff, G.1    Eichler, H.2    Brand, A.3    Kekomaki, R.4    Kurtz, J.5    Letowska, M.6
  • 29
    • 84879074262 scopus 로고    scopus 로고
    • International Conference on Harmonisation Harmonised Tripartite Guideline: Validation of Analytical Procedures: Text And Methodology Q2( R1) Current Step 4 version, Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November Ness Ziona, Israel. Accessed date: 14 April 2010
    • International Conference on Harmonisation. Harmonised Tripartite Guideline: Validation of Analytical Procedures: Text And Methodology Q2(R1) Current Step 4 version, Parent Guideline dated 27 October 1994 (Complementary Guideline on Methodology dated 6 November 1996 incorporated in November 2005), Ness Ziona, Israel. http://www.bioforum. org.il/Uploads/Editor/karen/q2-r1- step4.pdf. Accessed date: 14 April 2010.
    • (2005)
  • 30
    • 84879107398 scopus 로고    scopus 로고
    • Center for Biologics Evaluation and Research, Rockville, MD. Potency Tests for Cellular and Gene Therapy Products. FDA Draft Guidance for Industry. US Department of Health and Human Services; Accessed date: 14 April 2010
    • Center for Biologics Evaluation and Research, Rockville, MD. Potency Tests for Cellular and Gene Therapy Products. FDA Draft Guidance for Industry. US Department of Health and Human Services; 2008. http://www.fda.gov/downloads/ BiologicsBloodVaccines/ GuidanceComplianceRegulatoryInformation/ Guidances/CellularandGeneTherapy/ucm078687.pdf. Accessed date: 14 April 2010.
    • (2008)
  • 32
    • 72649083282 scopus 로고    scopus 로고
    • Transplantation of unrelated donor umbilical cord blood for nonmalignant diseases: A single institution's experience with 45 patients
    • Jaing TH, Chen SH, Tsai MH, Yang CP, Hung IJ, Tsay PK. Transplantation of unrelated donor umbilical cord blood for nonmalignant diseases: A single institution's experience with 45 patients. Biol Blood Marrow Transplant. 2010;16:102-7.
    • (2010) Biol Blood Marrow Transplant , vol.16 , pp. 102-107
    • Jaing, T.H.1    Chen, S.H.2    Tsai, M.H.3    Yang, C.P.4    Hung, I.J.5    Tsay, P.K.6
  • 33
    • 35348882039 scopus 로고    scopus 로고
    • Analysis of hematopoietic cell transplants using plasma-depleted cord blood products that are not red blood cell reduced
    • Chow R, Nademanee A, Rosenthal J, Karanes C, Jaing TH, Graham ML, et al. Analysis of hematopoietic cell transplants using plasma-depleted cord blood products that are not red blood cell reduced. Biol Blood Marrow Transplant. 2007;13: 1346-57.
    • (2007) Biol Blood Marrow Transplant , vol.13 , pp. 1346-1357
    • Chow, R.1    Nademanee, A.2    Rosenthal, J.3    Karanes, C.4    Jaing, T.H.5    Graham, M.L.6
  • 34
    • 84860413983 scopus 로고    scopus 로고
    • American Association of Blood Banks. Standards for Blood Banks and Transfusion Services, Bethesda, MD. 26th ed. AABB Standard: 5.18.1.2.4. American Association of Blood Banks
    • American Association of Blood Banks. Standards for Blood Banks and Transfusion Services, Bethesda, MD. 26th ed. AABB Standard: 5.18.1.2.4. American Association of Blood Banks; 2009.
    • (2009)
  • 35
    • 84860411622 scopus 로고    scopus 로고
    • NetCord-FACT Omaha NE. International Standards for Cord Blood Collection Banking and Release for Administration. 4th ed. FACT standard D7.5.1. NetCord-FACT
    • NetCord-FACT, Omaha, NE. International Standards for Cord Blood Collection, Banking, and Release for Administration. 4th ed. FACT standard D7.5.1. NetCord-FACT; 2010.
    • (2010)
  • 36
    • 33745455224 scopus 로고    scopus 로고
    • Multi-laboratory evaluation of procedures for reducing the volume of cord blood: Infl uence on cell recoveries
    • Takahashi TA, Rebulla P, Armitage S, van Beckhoven J, Eichler H, Kekomaki R, et al. Multi-laboratory evaluation of procedures for reducing the volume of cord blood: Infl uence on cell recoveries. Cytotherapy. 2006;8:254-64.
    • (2006) Cytotherapy , vol.8 , pp. 254-264
    • Takahashi, T.A.1    Rebulla, P.2    Armitage, S.3    Van Beckhoven, J.4    Eichler, H.5    Kekomaki, R.6
  • 38
    • 84879108708 scopus 로고    scopus 로고
    • Negative impact of post-thaw washing on the overall survival (OS) and disease free survival (DFS) of patients receiving plasma depleted (PD) cord blood (CB) transplantation
    • Abstract no: O-3917
    • Chow R, Law P, Wang B, Rosenthal J, Nademanee A, Karanes C, et al. Negative impact of post-thaw washing on the overall survival (OS) and disease free survival (DFS) of patients receiving plasma depleted (PD) cord blood (CB) transplantation. Biol Blood Marrow Transplant. 2009;15(Suppl 2) Abstract no: O-39:17.
    • (2009) Biol Blood Marrow Transplant , vol.15 , Issue.SUPPL. 2
    • Chow, R.1    Law, P.2    Wang, B.3    Rosenthal, J.4    Nademanee, A.5    Karanes, C.6
  • 39
    • 78649987228 scopus 로고    scopus 로고
    • Comparison of cord blood thawing methods on cell recovery, potency, and infusion
    • Regan DM, Wofford JD, Wall DA. Comparison of cord blood thawing methods on cell recovery, potency, and infusion. Transfusion. 2010;50:2670-5.
    • (2010) Transfusion , vol.50 , pp. 2670-2675
    • Regan, D.M.1    Wofford, J.D.2    Wall, D.A.3
  • 40
    • 70350569872 scopus 로고    scopus 로고
    • A 'no-wash'albumin-dextran dilution strategy for cord blood unit thaw: High rate of engraftment and a low incidence of serious infusion reactions
    • Barker JN, Abboud M, Rice RD, Hawke R, Schaible A, Heller G, et al. A ' no-wash'albumin-dextran dilution strategy for cord blood unit thaw: High rate of engraftment and a low incidence of serious infusion reactions. Biol Blood Marrow Transplant. 2009;15:1596-602.
    • (2009) Biol Blood Marrow Transplant , vol.15 , pp. 1596-1602
    • Barker, J.N.1    Abboud, M.2    Rice, R.D.3    Hawke, R.4    Schaible, A.5    Heller, G.6
  • 41
    • 84879097749 scopus 로고    scopus 로고
    • Cord Blood Transplantation Study (COBLT), Rockville, MD. Cord Blood Bank Standard Operating Procedures. Carolinas Cord Blood Bank-Duke University & University of California-Los Angeles Cord Blood Bank
    • Cord Blood Transplantation Study (COBLT), Rockville, MD. Cord Blood Bank Standard Operating Procedures. Carolinas Cord Blood Bank-Duke University & University of California- Los Angeles Cord Blood Bank. https://web.emmes.com/ study/ cord/sop.htm.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.