Legality and ethics

In the United States, cord blood education is supported by legislators at the federal and state levels. In response to their constituents, state legislators across the United States are introducing legislation intended to help inform physicians and expectant parents on the options for donating, discarding, or banking lifesaving newborn stem cells. Currently, 17 states, covering two-thirds of U.S. births, have enacted legislation recommended by the IoM guidelines.[citation needed]

In 2004, the European Group on Ethics in Science and New Technologies advised the European Commission that "The legitimacy of commercial cord blood banks for autologous [self] use should be questioned as they sell a service, which has presently, no real use regarding therapeutic options. Thus, they promise more than they can deliver. The activities of such banks raise serious ethical criticisms."[32] For those at low risk, private storage of one's own cord blood is unlawful in Italy and France, and discouraged in some other European states.[1][33]

Some doctors and patients have stated that the claims of some private cord blood banks are deceptive and misleading.[33][34][35]
[edit] Controversy among medical societies

The Royal College of Obstetricians and Gynaecologists 2006 opinion states, "There is still insufficient evidence to recommend directed commercial cord blood collection and stem-cell storage in low-risk families."[1]

The policy of the Society of Obstetricians and Gynaecologists of Canada (SOGC) supports public cord blood banking (similar to collection and banking of other blood products, i.e. altruistic, anyone can use it), as well as stating it should be considered under certain circumstances. SOGC Clinical Practice Guidelines, No. 156, March 2005.[36] Umbilical Cord Blood Banking: Implications for Perinatal Care Providers

The policy of the American Academy of Pediatrics policy states that "private storage of cord blood as 'biological insurance' is unwise" unless there is a family member with a current or potential need to undergo a stem cell transplantation.[2]

Similarly, the American College of Obstetricians and Gynecologists does not recommend private cord blood banking.

Private storage of one's own cord blood is unlawful in Italy and France, and it is discouraged in some other European states.[1][2][3] the American Academy of Pediatrics states that private cord blood banking is generally not recommended unless there is a family history of specific genetic diseases.[33]

The American Society for Blood and Marrow Transplantation[37] states that public donation of cord blood is encouraged where possible, the probability of using one's own cord blood is very small, and therefore storage of cord blood for personal use is not recommended, and family member banking (collecting and storing cord blood for a family member) is recommended when there is a sibling with a disease that may be treated successfully with allogeneic transplant.
[edit] Safety and effectiveness of using one's own cells unclear

Using one's own cord blood cells might not be wise or effective, especially in cases of childhood cancers and leukemia.[38] Children who develop an immunological disorder often are unable to use their own cord blood for transplant because the blood also contains the same genetic defect. Nearly all of the transplants using privately banked cord blood have gone to relatives with pre-existing conditions, not to the donors.[33]

Additional issues include the possible contamination of the cord blood unit with the same cancer diagnosed later in life; for example, abnormal cells have been detected in filters containing newborn blood of children who were not diagnosed with acute leukemia until the age of 2 to 6 years. The high relapse rates after autologous or syngeneic tranplant and the benefit of a graft-vs.-leukemia effect of an allogeneic transplant suggest that autologous cord blood would not be the ideal source of stem cells for patients with leukemia needing a transplant.[39]
[edit] Usability of one's own sample unknown

Most cord blood samples - up to 75% - may be too small to be used for transplantation because they don't contain enough stem cells.[33] While a private bank will store a sample, the sample may be too small to be usable, even by a child. Larger numbers of blood cells are required for adults because of their typically larger body mass.
[edit] Ownership of cord blood

As of 2007, contracts of the largest cord blood banks do not explicitly state that the cord blood belongs to the donors and child with all the rights and privileges one would reasonably expect from ownership. The ambiguity leaves open future uses not approved by the donors and child. Some contracts fail to spell out the rights of the donors requesting termination of storage: e.g. the right to request and verify destruction of the samples (as when a period of likely need has passed, or their minds have changed).[citation needed]
[edit] Medical issues

Concerns have been raised that the current interest in cord blood could cause a perception that cord blood is 'unused' by the birth process, thus decreasing the amount of blood which is infused into the child as part of the birth process. The pulsation of the cord pushes blood into the child, and it has been recommended that the cord cease pulsation prior to clamping. With the demand for cord blood increasing, there is a possibility that the cord could be clamped prematurely to preserve even more 'extra' cord blood. This action could have detrimental effects on the child's future development.[40]

The American Academy of Pediatricians notes: "if cord clamping is done too soon after birth, the infant may be deprived of a placental blood transfusion, resulting in lower blood volume and increased risk for anemia."[2]

The Journal of the American Academy of Pediatrics published an article in April 2006 recommending that clamping be delayed to reduce anemia and improve neonatal iron storage.[41]