Mislabeled units of umbilical cord blood detected by a quality assurance program at the transplantation center

Blood

Volumn 114, Issue 8, 2009, Pages 1684-1688

  McCullough, Jeffrey ^a   McKenna, David ^a   Kadidlo, Diane ^b   Maurer, David ^a   Noreen, Harriett J ^c   French, Kathy ^b   Brunstein, Claudio ^a   Wagner, John E ^a  

^a UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^b UNIVERSITY OF MINNESOTA   (United States)

^c UNIVERSITY OF MINNESOTA MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HLA ANTIGEN CLASS 1;

ADOLESCENT; ADULT; ARTICLE; BLOOD BANK; BLOOD GROUP ABO SYSTEM; CASE REPORT; ERYTHROCYTE; FEMALE; HEALTH CENTER; HEALTH PROGRAM; HUMAN; MALE; PRIORITY JOURNAL; QUALITY CONTROL; SCREENING; TRANSPLANTATION; UMBILICAL CORD BLOOD; BLOOD GROUP TYPING; BLOOD TRANSFUSION; FETUS BLOOD; MEDICAL ERROR; METHODOLOGY; MIDDLE AGED; ORGANIZATION AND MANAGEMENT; PACKAGING; STANDARD;

ADOLESCENT; BLOOD BANKS; BLOOD GROUPING AND CROSSMATCHING; BLOOD TRANSFUSION; EFFICIENCY, ORGANIZATIONAL; FEMALE; FETAL BLOOD; HUMANS; MALE; MEDICAL ERRORS; MIDDLE AGED; PRODUCT LABELING; QUALITY CONTROL;

EID: 70349577974     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2009-02-205047     Document Type: Article

References (31)

1. Gluckman E, Rocha V. History of the clinical use of umbilical cord blood hematopoietic cells. Cytotherapy. 2005;7:219-227. (Pubitemid 41051364)
2. Laughlin MJ, Barker J, Bambach B, et al. Hematopoietic engraftment and survival in adult recipients of umbilical cord blood from unrelated donors. N Engl J Med. 2001;344:1815-1822. (Pubitemid 32538694)
3. Barker JW, Davies SM, DeFor T, et al. Survival after transplantation of unrelated donor umbilical cord blood is comparable to that of human leukocyte antigen-matched unrelated donor bone marrow: results of a matched-pair analysis. Blood. 2001;97:2957-2961.
4. Laughlin MJ, Eapen M, Rubinstein P, et al. Outcomes after transplantation of cord blood or bone marrow from unrelated donors in adults with leukemia. N Engl J Med. 2004;351:2265-2275. (Pubitemid 39552742)
5. Rocha V, Labopin M, Sanz G, et al. Transplants of umbilical cord blood or bone marrow from unrelated donors in adults with acute leukemia. N Engl J Med. 2004;351:2276-2285. (Pubitemid 39552743)
6. Broxmeyer HE, Douglas GW, Hangoc G, et al. Human umbilical cord blood as a potential source of transplantable hematopoietic stem/progenitor cells. Proc Natl Acad Sci U S A. 1989;86:3828-3832. (Pubitemid 19141838)
7. Gluckman E, Broxmeyer HE, Auerbach AD, et al. Hematopoietic reconstitution in a patient with Fanconi anemia by means of umbilical cord blood from an HLA-identical sibling. N Engl J Med. 1989;321:1174-1178. (Pubitemid 19255814)
8. Rubinstein P, Carrier C, Scaradavou A, et al. Outcomes among 562 recipients of placental-blood transplants from unrelated donors. N Engl J Med. 1998;339:1565-1577.
9. Broxmeyer HE, Hangoc G, Cooper S, et al. Growth characteristics and expansion of human umbilical cord blood and estimation of its potential for transplantation in adults. Proc Natl Acad Sci U S A. 1992;89:4109-4113.
10. Rubinstein P, Rosenfield RE, Adamson JW, Stevens CE. Stored placental blood for unrelated bone marrow reconstitution. Blood. 1993;81: 1679-1690. (Pubitemid 23101579)
11. Barker JN, Krepski TP, DeFor TE, et al. Searching for unrelated donor hematopoietic stem cells: availability and speed of umbilical cord blood versus bone marrow. Biol Blood Marrow Transplant. 2002;8:257-260.
12. Steinbrook R. The cord blood bank controversies. N Engl J Med. 2004;22:2255-2257.
13. New York State Council on Human Blood and Transfusion Services. Guidelines for Collection, Processing and Storage of Cord Blood Stem Cells. Albany, NY: New York State Department of Health; 1997.
14. American Academy of Pediatrics. Cord blood banking for potential future transplantation: subject review. Pediatrics. 1999;104:116-118.
15. AMA Council on Ethical and Judicial Affairs. Code of Medical Ethics: E-2.165. In: Fetal Umbilical Cord Blood: Current Opinions With Annotations (1996-1997 Ed.). Chicago, IL: American Medical Association; 1997.
16. Committee on Obstetric Practice, Committee on Genetics. Routine Storage of Umbilical Cord Blood for Potential Future Transplantation (Committee Opinion 183). Washington, DC: American College of Obstetricians and Gynecologists; 1997.
17. Institute of Medicine of the National Academies. In: Mayer EA, Hanna K, Gebbie K, eds. Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program. Washington, DC: National Academies Press; 2005.
18. Alonso JM, Regan DM, Johnson CE, et al. A simple and reliable procedure for cord blood banking, processing and freezing: St. Louis and Ohio Cord Blood Bank experiences. Cytotherapy. 2001;3:429-433.
19. Roback JD, Combs MR, Grossman BJ, Hillyer CD, eds. Technical Manual. 16th Ed. Bethesda, MD: American Association of Blood Banks; 2008: 21.
20. McCullough J, McKenna D, Kadidlo D, et al. Issues in the quality of umbilical cord blood stem cells for transplantation. Transfusion. 2005;45: 832-841. (Pubitemid 40798773)
21. Net Cord Foundation for the Accreditation of Cellular Therapy. International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release. 3rd Ed. Bethesda, MD: American Association of Blood Banks; 2006.
22. American Association of Blood Banks. Standards for Cellular Therapy Product Services. 2nd Ed. Bethesda MD: American Association of Blood Banks; 2007.
23. Food and Drug Administration. Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement: final rule. Fed Regist. 2004;69:68611-68688.
24. Food and Drug Administration. Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products: final rule. Fed Regist. 2004;69:29786-29834.
25. Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; December 2006.
26. McCullough J, Kadidlo D, Krepski T, et al Erroneous labeling of a cord blood unit detected by quality control testing of the final product [abstract]. Cytotherapy. 2003;5:471.
27. Hubel A, Carlquist D, Clay M, McCullough J. Short-term liquid storage of umbilical cord blood. Transfusion. 2003;43:626-632. (Pubitemid 36506359)
28. Hubel A, Carlquist D, Clay M, McCullough J. Liquid storage, shipment, and cryropreservation of cord blood. Transfusion. 2004;44:518-525. (Pubitemid 38437587)
29. Hubel A, Carlquist D, Clay M, McCullough J. Cryopreservation of cord blood after liquid storage. Cytotherapy. 2003;5:370-376. (Pubitemid 37369024)
30. Gluckman E, Rocha V. Donor selection for unrelated cord blood transplants. Curr Opin Immunol. 2006;18:565-570. (Pubitemid 44311457)
31. Eapen M, Rubinstein P, Ahang MJ, et al. Outcomes of transplantation of unrelated donor umbilical cord blood and bone marrow in children with acute leukaemia: a comparison study. Lancet. 2007;369:1-8.