Saving the leftovers: Models for banking cord blood stem cells

Issues in Law and Medicine

Volumn 25, Issue 2, 2009, Pages 145-165

  Cogdell, Kimberly J ^a,b  

^a NORTH CAROLINA CENTRAL UNIVERSITY   (United States)

^b Biotechnology and Pharmaceutical Law Institute

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BLOOD BANK; CORD BLOOD STEM CELL TRANSPLANTATION; FETUS BLOOD; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MANAGEMENT; ORGANIZATION AND MANAGEMENT; PUBLIC HEALTH SERVICE; UNITED STATES;

BLOOD BANKS; CORD BLOOD STEM CELL TRANSPLANTATION; FETAL BLOOD; HUMANS; INFORMED CONSENT; OWNERSHIP; POLICY MAKING; PUBLIC HEALTH PRACTICE; UNITED STATES;

EID: 73349135966     PISSN: 87568160     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (132)

1. Sheryl G. Stolberg, Bush Vetos Measure on Stem Cell Research, N.Y. TIMES, June 21, 2007, http://www.nytimes.com/2007/06/21/washington/ 21stem.html?r=1&oref=slogin.
2. American Academy of Pediatrics, Frequently Asked Questions, http://www.aap.org/advocacy/releases/jano7cordbloodfaq.htm (last visited July 7, 2007).
3. Id.
4. March of Dimes, http://www.marchofdimes.com/peristats/tlanding.aspx?reg= 99&lev=o&top=2&slev=1&dv=qf (last visited July 6, 2007) (citing information obtained from National Center for Health Statistics & U.S. Bureau of the Census). Bone marrow contains immature stem cells that develop into different types of cells.
5. Id.
6. See infra Part IV.
7. See New York Blood Center National Cord Blood Program, http://www.nationalcordbloodprogram.org/about/program-overview.html (last visited July, 2007).
8. Id.
9. Id.
10. A hematopoietic cell is a cell from blood or bone marrow that can renew itself and differentiate to a variety of specialized cells.
11. Id.
12. See Michael J. Malinowski & Radhika Rao, Legal Limitations on Genetic Research and the Commercialization of its Results, 54 AM. J. COMP. L. 45 (2006).
13. "Embryo adoption/donation" is a new term used to describe the process by which couples with unused embryos may donate or transfer them to others for in vitro fertilization. Embryo Adoption Awareness Campaign, Nightlight Christian Adoptions, http://www.mbryoadoption.org (last visited Sept. 22, 2008).
14. WebMD Health, In Vitro Fertilization, http://www.medscape.com/ viewarticle/470281 (last visited Jan. 12,2009).
15. The Henry J. Kaiser Family Foundation, Most U.S. IVF Clinics Discard Unused Embryos: Many Embryos Remain in Storage for Years, Study Says (2004), http://www.kaisernetwork.org/daily-reports/print-report.cfm?DR-ID= 25538&dr-cat=2 (last visited Sept.22, 2008).
16. Patricia Anstett, Babies Provide Lifelines; Umbilical Cord Stem Cells Aid in Transplants for Leukemia Patients, Others, CHARLOTTE OBSERVER, NOV. 7,2005, available at http://stemcellnews.com/ articles/stem-cells-cord-blood-coalition.htm.
17. Delivery intake refers to the point at which a woman is admitted to a hospital for childbirth.
18. See California v. Greenwood, 486 U.S. 35 (1988) (holding that because a defendant had disposed of household trash by leaving it on the curb, he had no reasonable expectation of privacy as to its contents; therefore, law enforcement agents' search of the trash was not an unreasonable search and the evidence collected was admitted at trial).
19. See Wash. Univ. v. Catalona, 490 F.3d 667 (8th Cir. 2007);
20. Greenberg v. Miami Children's Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003).
21. Yael Bregman-Eschet, Genetic Databases and Biobanks: Who Controls Our Genetic Privacy? 23 SANTA CLARA COMPUTER & HIGH TECH. L. J. 1, 2-3 (2006) (listing the countries having genetic databases).
22. Lori B. Andrews, Harnessing the Benefits of Biobanks, 33 J. L. MED. & ETHICS 22, 23 (2005).
23. The Hastings Center, Biobanks: DNA and Research, http://www. thehastingscenter.org/Publications/BriefingBook/Detail.aspx?id=2154 (last visited Feb. 3, 2009).
24. Id.
25. Andrews, supra note 20, at 23.
26. Id.
27. M. Thomas et al., Ownership of the Human Genome, 380 NATURE 387-88. (1996).
28. Andrews, supra note 20, at 26.
29. National Marrow Donor Program, http://www.marrow.org/HELP/Donate-Cord- Blood-Share-Life/index.html (last visited July 7, 2007).
30. Id.
31. Id.
32. Duke Opens 3rd U.S. Cord Blood Bank, DURHAM HERALDSUN, Apr. 1, 1998, available at http://www.cancer.duke.edu/ccbb/article2.asp.
33. Carolinas Cord Blood Bank, http://www.cancer.duke.edu/ccbb/ (last visited Sept. 22, 2008).
34. Id. These eight hospitals include: Memorial Hospital at the University of North Carolina, Duke North Hospital at Duke University Medical Center, Durham Regional Hospital, Western Wake Hospital, Women's Hospital of Greensboro, and Rex Hospital.
35. Coriell Institute for Medical Research, http://www.coriell.org/index.php/ content/view/53/104/ (last visited Jan. 12,2009).
36. Joanne Kurtzberg, Anne D. Lyerly & Jeremy Sugarman, Untying the Gordian Knot: Policies, Practices and Ethical Issues Related to Banking of Umbilical Cord Blood, 115 J. CLINICAL INVESTIGATION 2592-97 (Oct. 2005).
37. EMILY A. MEYER, KATHI HANNA & KRISTIE GEBBIE, CORD BLOOD: ESTABLISHING A NATIONAL HEMATOPOIETIC STEM CELL BANK PROGRAM (2005).
38. Press Release, Office of the Press Secretary, President Signs the "Stem Cell Therapeutic Research Act of 2005," (Dec. 20, 2005), available at http://www.whitehouse.gov/news/releases/2005/12/20051220-1. html (last visited July 7, 2007).
39. See www.cordblood.com/cord-blood-banking-with-cbr/pricing- domestic.asp (last visited Jan. 12, 2009). The Cord Blood Registry charges $1,995 for the first year of storage plus registration fee.
40. Id.
41. Janine DeFao, Is it Worth Banking Your Baby's Cord Blood? SAN FRANCISCO CHRON., June 20, 2005, at A1.
42. Suzanne Leigh, Law Annoys Private Cord Banks, WIRED, Jan. 31, 2006, http://www.wired.com/science/discoveries/news/2006/01/70091.
43. American Academy of Pediatrics, Frequently Asked Questions, http://www.aap.org/advocacy/releases/jano7cordbloodfaq.htm (last visited July 7, 2007).
44. The cells would be unusable because of pre-malignancy changes in the stem cells.
45. American Academy of Pediatrics, supra note 40.
46. Michael J. Malinowski, Technology Transfer in Biobanking: Credits, Debits and Population Health Futures, 33 J. L. MED. & ETHICS 54 (2005).
47. Id. at 59.
48. Sharon Gerecht-Nir, Liron Eldor & Joseph Itskovitz-Eldor, Advances in Human Stem Cell Research, 46 CLINICAL OBSTETRICS & GYNECOLOGY 2, 218-30 (2003).
49. Id.
50. Pluripotent cells can produce new cells that come from the three germ layers: endoderm, ectoderm and mesoderm. They are different from totipotent cells, which have the ability to form an embryo and membranes and tissues because pluripotent stem cells cannot form the complete embryo.
51. See supra note 45.
52. Self-renewal occurs when a cell produces identical copies of itself.
53. See supra note 45.
54. Id. at 220.
55. E. Gluckman & V. Rocha, History of the Clinical Use of Umbilical Cord Blood Hematopoietic Cells, 7 CYTOTHERAPY 219, 222 (2005).
56. I. D. Lewis et al., Umbilical Cord Blood Cells Capable of Engrafting in Primary, Secondary, and Tertiary Xenogeneic Hosts Are Preserved After Ex Vivo Culture in a Noncontact System, 97 BLOOD 3441, 3441-49 (2001).
57. Colin McGuckin et al., Embryonic-like Stem Cells From Umbilical Cord Blood and Potential for Neural Modeling, 66 ACTA NEUROBIOL. EXP. 321, 323 (2006).
58. Jennifer Gunning, Umbilical Cord Cell Banking - Implications for the Future, 207 TOXICOLOGY & APPLIED PHARMACOLOGY 538, 539 (2005).
59. The first cord blood stem cell transplant occurred in 1988. E. Gluckman et al., Hematopoietic Reconstitution in a Patient with Fanconi's Anemia by Means of Umbilical Cord Blood From an HLA-Identical Sibling, 321 NEW ENG. J. MED. 1174, 1174-78 (1989).
60. Hal E. Broxmeyer et al., Human Umbilical Cord Blood as a Potential Source of Transplantable Hematopoietic Stem/Progenitor Cells, 86 PROCEEDINGS OF THE NAT'L ACAD. SCI. 3828, 3828-32 (1989).
61. This applies in situations where cord blood stem cell transplants can be used in place of bone marrow transplants.
62. Broxmeyer, supra note 57.
63. American Academy of Pediatrics Encourages Public Cord Blood Banking, available at http://www.aap.org/advocacy/releases/jano7cordblood.htm (last visited July 7, 2007).
64. See Cord Blood Banking for Potential Future Transplantation, 119 PEDIATRICS 165, 166 (2007) (stating in Table 1 the American Academy of Pediatrics' Policy Statement).
65. Bone Marrow Transplant and Peripheral Blood Stem Cell Transplantation: Questions and Answers, National Cancer Institute Fact Sheet, available at http://www.cancer.gov/cancertopics/factsheet/Therapy/bone-marrow-transplant (last visited July 7, 2007) (distinguishing between stem cells in allogenic transplants that may come from a family member or an unrelated donor from autologous transplants in which patients receive their own stem cells).
66. Gluckman & Rocha, supra note 52.
67. See id.
68. National Cancer Institute Fact Sheet, supra note 62.
69. Kurtzberg, supra note 34, at 2592.
70. National Marrow Donor Program, The Need for Donors, http://www.marrow. org/ABOUT/Need-for-Donors/index.html (last visited Nov. 24, 2008).
71. Id.
72. Id.
73. Bone MarrowTransplant Information, http://cpmcnet.columbia.edu/dept/ medicine/bonemarrow/bmtinfo.html (last visited July 7, 2007) (stating that over 7,500 people underwent bone marrow transplants in 1991).
74. Id.
75. Id.
76. This data applies to matches for patients suffering from leukemia, lymphoma and other disorders treatable with transplantation. See Kurtzberg, supra note 34, at 2594.
77. National Marrow Donor Program, The Need for Donors, http://www.marrow. org/ABOUT/Need-for-Donors/index/html (last visited Dec. 12, 2008).
78. Supra note 73.
79. Mary E. Glasgow & Gerald Bellow, Bone Marrow Donation: Factors Influencing Intentions in African Americans, 34 ONCOLOGY NURSING FORUM 369 (2007).
80. See The Need for Donors, supra note 74 (describing the community outreach and partnership activities in the Black community and the need for more donors).
81. For example, in 2006, 26% of all recipients from these groups received cord blood stem cell transplants. National Cord Blood Program, Cord Blood. Q & A, http://www.nationalcordbloodprogram.org/qa/what-is-significance.html (last visited Oct. 25,2008).
82. Barbara J. Evans & Eric M. Meslin, Encouraging Translational Research Through Harmonization of FDA and Common Rule Informed Consent Requirements for Research with Banked Specimens, 27 J. LEGAL MED. 119, 120 (2006).
83. Henry T. Greely, Population Participation and Other Factors that Impact the Compilation and the Utility of Resulting Databases, 66 LA. L. REV. 79, 79 (2005).
84. Domenic A. Crolla, Reflections on the Legal, Social and Ethical Implications of Pharmacogenomic Research, 46 JURIMETRICS J. 239, 239-40 (2006).
85. Kurtzberg, supra note 34, at 2594.
86. California v. Greenwood, 486 U.S. 35 (1988).
87. Id.
88. Id. at 40-41.
89. State v. Tanaka, 701 P.2d 1274 (Haw. 1985) (holding that under the Hawaiian Constitution the defendants had a reasonable expectation of privacy in their trash bags and that the police officers seizure without a warrant violated the prohibition against unreasonable searches and seizures);
90. State v. Hempele, 576 A.2d 793 (N.J. 1990) (finding that a person has a reasonable expectation of privacy in garbage left at curbside);
91. State v. Morris, 680 A.2d 90 (Vt. 1996) (finding that a person has an objectively reasonable privacy interest in garbage);
92. State v. Boland, 800 P.2d 1112 (Wash. 1990) (holding that the defendanf's private affairs were unreasonably intruded upon when the police removed garbage from the defendant's trash can).
93. Such materials include the placenta, cord blood stem cells, and other birth related fluids and materials routinely discarded after childbirth.
94. 264 F. Supp. 2d 1064 (S.D. Fla. 2003).
95. Id. at 1067.
96. Id.
97. Id. at 1068.
98. Id. at 1068-77.
99. Id. at 1075 (discussing conversion theory).
100. 437 F. Supp. 2d 985 (E.D. Mo. 2006).
101. Id. at 997.
102. Id.
103. Mayo Clinic, Organ Donation, www.mayoclinic.org/transplant/organ- donation.html (last visited Sept. 22, 2008) ("[O]ver 97,000 people are waiting for transplant surgeries 17 people die each day waiting for transplants that can't take place because of the shortage of donated organs.").
104. United Network for Organ Sharing, Organ Donation and Transplantation, www.unos.org (last visited July 8, 2007);
105. see also supra note 70.
106. REVISED UNIFORM ANATOMICAL GIFT ACT pref. n. (amended 2007), available at http:// anatomicalgiftact.org/DesktopDefault.aspx?tabindex=1&tabid=63 (last visited July 8, 2007).
107. Sarah E. Statz, Finding the Winning Combination: How Blending Organ Procurement Systems Used Internationally Can Reduce the Organ Shortage, 39 VAND. J. TRANSNAT'L L. 1677, 1680 (2006).
108. Id. at 1683.
109. Id. at 1687.
110. See UNIF. ANATOMICAL GIFT ACT § 2(b) (1987).
111. The representative is usually deemed to be the next of kin. See REVISED UNIF. ANATOMICAL GIFT ACT § 9 (2006) (prioritizing the order of representatives that can make a gift: (1) agent of the decedent; (2) spouse of the decedent; (3) adult sibling of decedent; (4) adult grandchild of decedent; (5) grandparent of the decedent; (6) adult who exhibited special care and concern for decedent; (7) guardian of the decedent at the time of death; and (8) any person having authority to dispose of the body).
112. See UNIF. ANATOMICAL GIFT ACT § 4 (2006) (requiring the coroner or medical examiner in possession of an unclaimed body to make an anatomical gift only after receiving a request for the body part from a hospital, making a reasonable effort to locate and inform the next of kin).
113. Statz, supra note 100, at 1688.
114. See Ohio Donor Registry, http://www.donatelifeohio.org/ ohiodonorregistry/ (last visited July 8, 2007).
115. Press Release, Ohio Bureau of Motor Vehicles, BMV Celebrates Fourth Anniversary of Organ Donor Registry (June 30, 2006), available at http://bmv.ohio.gov/pdf-files/o6-30-o6%2oBMV%C2oDonor%C20Registry%2oRelease.pdf Oast visited July 8,2007).
116. See generally Statz, supra note 100.
117. Id. at 1697.
118. Id. at 1691-95.
119. Id. at 1697.
120. Id. at 1695.
121. Id.
122. Id.
123. Id.
124. As a faculty observer to a course in comparative bioethics and policy held at the University of Salamanca, sponsored by the Case Western Reserve University School of Medicine, Department of Bioethics, I had the opportunity to see the Spanish transplant system up close.
125. These observations are based upon my experience as a Faculty Observer in the Comparative Bioethics Course sponsored by Case Western Reserve University.
126. No patients were in the unit at the time.
127. See 42 U.S.C. § 274 (2006).
128. D. M. Gitter, Ownership of Human Tissue: A Proposal for Federal Recognition of HumanResearch Participants'Property Rights in Their Biological Material,61 WASH. & LEE L. REV. 315, 315-24 (2004).
129. Brian Su, Developing Biobanking Policy With an Oliver Twist: Addressing the Needs of Orphan and Neglected Diseases, 66 LA. L. REV. 771, 774 (2006).
130. See supra note 21.
131. See id.
132. See 42 U.S.C. § 1320 et. seq. (2006).