Validation of short-term handling and storage conditions for marrow and peripheral blood stem cell products

Transfusion

Volumn 51, Issue 1, 2011, Pages 137-147

  Kao, Grace S ^a,b,c,d   Kim, Haesook T ^a,b,c,d   Daley, Heather ^a,b,c,d   Ritz, Jerome ^a,b,c,d   Burger, Scott R ^a,b,c,d   Kelley, Linda ^a,b,c,d   Vierra Green, Cynthia ^a,b,c,d   Flesch, Sue ^a,b,c,d   Spellman, Stephen ^a,b,c,d   Miller, John ^a,b,c,d   Confer, Dennis ^a,b,c,d  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b Advanced Cell and Gene Therapy   (United States)

^c UNIVERSITY OF UTAH   (United States)

^d NATIONAL MARROW DONOR PROGRAM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CD34 SELECTION; CELL METABOLISM; CELL VIABILITY; HEMATOPOIETIC STEM CELL; HUMAN; HUMAN CELL; NORMAL HUMAN; PERIPHERAL BLOOD MONONUCLEAR CELL; PERIPHERAL BLOOD STEM CELL; STORAGE TEMPERATURE; VALIDATION PROCESS;

CELL SURVIVAL; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HEMATOPOIETIC STEM CELLS; HUMANS; LEUKOCYTES, MONONUCLEAR; TEMPERATURE; TIME FACTORS; TISSUE PRESERVATION; TRANSPLANTATION, HOMOLOGOUS;

EID: 78651378447     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/j.1537-2995.2010.02758.x     Document Type: Article

References (27)

1. NMDP standards. 20th ed. St Paul (MN): National Donor Program; 2009.
2. FACT-JACIE international standards for cellular therapy product collection, processing, and administration. 4th ed. Omaha (NE): FACT-JACIE International Standards; 2008.
3. Standards for cellular therapy product services. 3rd ed. Bethesda (MD): AABB; 2008.
4. 21CFR Part 610 Section 610.12: Sterility. Vol. 7: Code of Federal Regulations; April 1, 2009: 70-5.
5. United States Pharmacopeia 28 and National Formulary 23 (USP 28 NF 23), Sterility Tests, General Chapter 71. 2005: 1-13.
6. Cleveland WS,. Robust locally weighted regression and smoothing scatterplots. J Am Stat Assoc 1979; 74: 829-36.
7. Fan J,. Design-adaptive nonparametric regression. J Am Stat Assoc 1992; 87: 998-1004.
8. Philpott NJ, Turner AJ, Scopes J, Westby M, Marsh JC, Gordon-Smith EC, Dalgleish AG, Gibson FM,. The use of 7-amino actinomycin D in identifying apoptosis: simplicity of use and broad spectrum of application compared with other techniques. Blood 1996; 87: 2244-51.
9. de Boer F, Dräger AM, Pinedo HM, Kessler FL, van der Wall E, Jonkhoff AR, van der Lelie J, Huijgens PC, Ossenkoppele GJ, Schuurhuis GJ,. Extensive early apoptosis in frozen-thawed CD34-positive stem cells decreases threshold doses for haematological recovery after autologous peripheral blood progenitor cell transplantation. Bone Marrow Transplant 2002; 29: 249-55.
10. Kilkson H, Holme S, Murphy S,. Platelet metabolism during storage of platelet concentrates at 22 degrees C. Blood 1984; 64: 406-14.
11. Murphy S, Shimizu T, Miripol J,. Platelet storage for transfusion in synthetic media: further optimization of ingredients and definition of their roles. Blood 1995; 86: 3951-60.
12. Tsagias N, Kouzi-Koliakos K, Karagiannis V, Alamdari DH, Koliakos G,. Time and temperature before processing influence the recovery of umbilical cord blood hematopoietic progenitors. Transfusion 2007; 47: 1550-2.
13. Moldenhauer A, Wolf J, Habermann G, Genter G, Kiesewetter H, Salama A,. Optimum storage conditions for cord blood-derived hematopoietic progenitor cells prior to isolation. Bone Marrow Transplant 2007; 40: 837-42.
14. Burger SR, Hubel A, McCullough J,. Development of an infusible-grade solution for non-cryopreserved hematopoietic cell storage. Cytotherapy 1999; 1: 123-33.
15. Pettengell R, Woll PJ, O'Connor DA, Dexter TM, Testa NG,. Viability of haemopoietic progenitors from whole blood, bone marrow and leukapheresis product: effects of storage media, temperature and time. Bone Marrow Transplant 1994; 14: 703-9.
16. Lasky LC, McCullough J, Zanjani ED,. Liquid storage of unseparated human bone marrow. Evaluation of hematopoietic progenitors by clonal assay. Transfusion 1986; 26: 331-4.
17. Koà ON, Gerson SL, Phillips GL, Cooper BW, Kutteh L, Van Zant G, Reece DE, Fox RM, Schupp JE, Tainer N, Lazarus HM,. Autologous CD34+ cell transplantation for patients with advanced lymphoma: effects of overnight storage on peripheral blood progenitor cell enrichment and engraftment. Bone Marrow Transplant 1998; 21: 337-43.
18. Burnett AK, Tansey P, Hills C, Alcorn MJ, Sheehan T, McDonald GA, Banham SW,. Haematological reconstitution following high dose and supralethal chemo-radiotherapy using stored, non-cryopreserved autologous bone marrow. Br J Haematol 1983; 54: 309-16.
19. Ager S, Mahendra P, Jestice HK, Scott M, Marcus RE,. The use of non-cryopreserved peripheral blood progenitor cells in autologous transplantation. Bone Marrow Transplant 1995; 16: 633-4.
20. Sugrue MW, Hutcheson CE, Fisk DD, Roberts CG, Mageed A, Wingard JR, Moreb JS,. The effect of overnight storage of leukapheresis stem cell products on cell viability, recovery, and cost. J Hematother 1998; 7: 431-6.
21. Petzer AL, Gunsilius E, Zech N, Clausen J, Hoflehner E, Nussbaumer W, Gastl G,. Evaluation of optimal survival of primitive progenitor cells (LTC-IC) from PBPC apheresis products after overnight storage. Bone Marrow Transplant 2000; 25: 197-200.
22. Mangalik A, Robinson WA, Drebing C, Hartmann D, Joshi JH,. Liquid storage of bone marrow. Exp Hematol 1979; 7 Suppl 5: 76-94.
23. Beaujean F, Pico J, Norol F, Divine M, Le Forestier C, Duedari N,. Characteristics of peripheral blood progenitor cells frozen after 24 hours of liquid storage. J Hematother 1996; 5: 681-6.
24. Lazarus HM, Pecora AL, Shea TC, Koà ON, White JM, Gabriel DA, Cooper BW, Gerson SL, Krieger M, Sing AP,. CD34+ selection of hematopoietic blood cell collections and autotransplantation in lymphoma: overnight storage of cells at 4 degrees C does not affect outcome. Bone Marrow Transplant 2000; 25: 559-66.
25. Emminger W, Emminger-Schmidmeier W, Hocker P, Hinterberger W, Gadner H,. Myeloid progenitor cells (CFU-GM) predict engraftment kinetics in autologous transplantation in children. Bone Marrow Transplant 1989; 4: 415-20.
26. Douay L, Gorin NC, Mary JY, Lemarie E, Lopez M, Najman A, Stachowiak J, Giarratana MC, Baillou C, Salmon C, Duhamel G,. Recovery of CFU-GM from cryopreserved marrow and in vivo evaluation after autologous bone marrow transplantation are predictive of engraftment. Exp Hematol 1986; 14: 358-65.
27. Antonenas V, Garvin F, Webb M, Sartor M, Bradstock KF, Gottlieb D,. Fresh PBSC harvests, but not BM, show temperature-related loss of CD34 viability during storage and transport. Cytotherapy 2006; 8: 158-65.