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03/2008 ASBMT »
02/2008 ACOG »
11/2007 AMA »
01/2007 AAP »
06/2006 WMDA »
06/2006 RCOG »
11/2004 NEJM »
03/2004 PLoS »
03/2004 EGE »
06/1999 AAP »
04/1997 ACOG »
Opinions of Medical Societies
American Society for Blood and Marrow Transplantation (ASBMT)
The ASBMT 2008 Position Statement on "Collection and Preservation of Cord Blood for Personal Use" is based on the ASBMT 2008 Committee Report on this topic, and both were accepted for publication in Nov 2007.
The ASBMT 2008 Position Statement appeared inthe same issue of the journal BBMT as the updated odds of use statistics by Nietfeld et al. 2008. The authors of Nietfeld et al., which include the Chief Scientific Director of CIBMTR, submitted a Letter to the Editor of BBMT correcting the statistics.
The committee report concedes, "It is possible, but not yet known, whether privately banked CB eventually might be used for treatment of nonmalignant conditions and have wider applications." ... "The committee acknowledges the potential for an expansion of indications for CB in the future, and these recommendations will be reviewed periodically so that they remain consistent with current medical knowledge."
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The ASBMT 2008 Position Statement appeared inthe same issue of the journal BBMT as the updated odds of use statistics by Nietfeld et al. 2008. The authors of Nietfeld et al., which include the Chief Scientific Director of CIBMTR, submitted a Letter to the Editor of BBMT correcting the statistics.
The committee report concedes, "It is possible, but not yet known, whether privately banked CB eventually might be used for treatment of nonmalignant conditions and have wider applications." ... "The committee acknowledges the potential for an expansion of indications for CB in the future, and these recommendations will be reviewed periodically so that they remain consistent with current medical knowledge."
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American College of Obstetricians and Gynecologists (ACOG)
The ACOG 2008 Opinion on "Umbilical Cord Blood Banking" is much more inclusive than their old 1997 Opinion, stating that: "If a patient requests information on umbilical cord blood banking, balanced and accurate information regarding the advantages and disadvantages of public versus private banking should be provided." A press release which accompanied the Opinion also stressed that ACOG took a neutral stance on cord blood banking.
Parents please note: Unlike the opinions of their Ethics Committee, which are available to the public, the ACOG considers their Opinion #399 on Umbilical Cord Blood Banking to be a "for sale item" and I am not allowed to post it on the internet.
Unfortunately, the authors of the Opinion did not understand the statistics for odds of using the cord blood in a family bank. They state repeatedly that the chance of umbilical cord blood being used "for a child or a family member"... "is approximately 1 in 2,700". The number 1 in 2,700 comes from Johnson 1997 and only refers to the child using its own (autologous) blood. The correct probability of a child (up to age 20) having an autologous stem cell transplant is 1 in 5,000 (Nietfeld et al. 2008). To include the chance of use by other family members, that number must be increased by adding the odds of each sibling requiring an allogeneic transplant from a donor, multiplied by the 39% chance that the sibling and donor are at least a 4/6 match. Also the odds of a parent needing a transplant should be considered; although the parent is probably only a 3/6 match to the child, the probability of needing a transplant increases drastically with age (Nietfeld et al. 2008). Finally, the Opinion does not consider new uses of cord blood in clinical trials.
ACOG also emphasizes that "Physicians or other professionals who recruit pregnant women and their families for for-profit umbilical cord blood banking should disclose any financial interests or other potential conflicts of interest."
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Parents please note: Unlike the opinions of their Ethics Committee, which are available to the public, the ACOG considers their Opinion #399 on Umbilical Cord Blood Banking to be a "for sale item" and I am not allowed to post it on the internet.
Unfortunately, the authors of the Opinion did not understand the statistics for odds of using the cord blood in a family bank. They state repeatedly that the chance of umbilical cord blood being used "for a child or a family member"... "is approximately 1 in 2,700". The number 1 in 2,700 comes from Johnson 1997 and only refers to the child using its own (autologous) blood. The correct probability of a child (up to age 20) having an autologous stem cell transplant is 1 in 5,000 (Nietfeld et al. 2008). To include the chance of use by other family members, that number must be increased by adding the odds of each sibling requiring an allogeneic transplant from a donor, multiplied by the 39% chance that the sibling and donor are at least a 4/6 match. Also the odds of a parent needing a transplant should be considered; although the parent is probably only a 3/6 match to the child, the probability of needing a transplant increases drastically with age (Nietfeld et al. 2008). Finally, the Opinion does not consider new uses of cord blood in clinical trials.
ACOG also emphasizes that "Physicians or other professionals who recruit pregnant women and their families for for-profit umbilical cord blood banking should disclose any financial interests or other potential conflicts of interest."
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American Medical Association (AMA)
The AMA 2007 Recommendation on "Umbilical Cord Blood Banking" is a one page summary of the AMA 2007 Opinions of the Council on Ethical and Judicial Affairs, which is a 36 page document covering many topics (see pages 125 - 129).
The AMA concludes "The utility of umbilical cord blood stem cells is greater when the donation is to a public rather than private bank. Therefore, physicians should encourage women who wish to donate cord blood to donate to a public bank if one is available. Doing so will result in greater availability of stem cells to patients from minority populations."
However, as with the AAP 2007 Opinion, this document quotes out-dated numbers for the lifetime probability that a person will have a stem cell transplant, and does not consider the clinical trials on autologous use of cord blood for Cerebral Palsy or Type 1 Diabetes.
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The AMA concludes "The utility of umbilical cord blood stem cells is greater when the donation is to a public rather than private bank. Therefore, physicians should encourage women who wish to donate cord blood to donate to a public bank if one is available. Doing so will result in greater availability of stem cells to patients from minority populations."
However, as with the AAP 2007 Opinion, this document quotes out-dated numbers for the lifetime probability that a person will have a stem cell transplant, and does not consider the clinical trials on autologous use of cord blood for Cerebral Palsy or Type 1 Diabetes.
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American Academy of Pediatrics (AAP)
The AAP 2007 Opinion on "Cord Blood Banking for Potential Future Transplantation" is written from the perspective of pediatric oncologists.
This Opinion pre-dates the 03/2008 publication by Nietfeld et al. on the lifetime probability that a person will have a stem cell transplant. It states "No accurate estimates exist of the likelihood of children to need their own stored cord blood stem cells in the future."
The concluding recommendations state: "Because there are no scientific data at the present time to support autologous cord blood banking ... private storage of cord blood as 'biological insurance' should be discouraged." As counter example, see the page on children who used their own cord blood: In 2008 there was more than one autologous therapy per week, as part of several clinical trials. These new treatments fall in the realm of regenerative medicine, helping the body to repair itself, and are not the traditional oncology/hematology transplants to which the authors of the Opinion restricted their consideration.
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This Opinion pre-dates the 03/2008 publication by Nietfeld et al. on the lifetime probability that a person will have a stem cell transplant. It states "No accurate estimates exist of the likelihood of children to need their own stored cord blood stem cells in the future."
The concluding recommendations state: "Because there are no scientific data at the present time to support autologous cord blood banking ... private storage of cord blood as 'biological insurance' should be discouraged." As counter example, see the page on children who used their own cord blood: In 2008 there was more than one autologous therapy per week, as part of several clinical trials. These new treatments fall in the realm of regenerative medicine, helping the body to repair itself, and are not the traditional oncology/hematology transplants to which the authors of the Opinion restricted their consideration.
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World Marrow Donor Association (WMDA)
The World Marrow Donor Association works to ensure high-quality hematopoietic (blood) stem cells are available for patients worldwide and to protect stem cell donors across borders. They are a voluntary organization of representatives from blood stem cell registries, blood banks, and others interested in blood stem cell transplantation.
In June 2006 the WMDA issued a Policy Statement for the Utility of Autologous of Family Cord Blood Unit Storage (8 page pdf file). The statement primarily follows the Opinion of the European Group on Ethics.
The WMDA goes a farther than other statements by medical societies by describing examples of "false or misleading" advertising by private cord blood banks.
In June 2006 the WMDA issued a Policy Statement for the Utility of Autologous of Family Cord Blood Unit Storage (8 page pdf file). The statement primarily follows the Opinion of the European Group on Ethics.
The WMDA goes a farther than other statements by medical societies by describing examples of "false or misleading" advertising by private cord blood banks.
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Royal College of Obstetricians and Gynaecologists (RCOG)
"The RCOG strongly supports the concept of an NHS Cord Blood Bank for
allogeneic storage of donated cord blood and would like to see it
well-funded. However, it remains unconvinced of the benefit of
personal commercial banking for low-risk families. It is our view that
if undertaken, advertising literature for commercial cord blood banks
should be fair and informative and pricing structures transparent.
Blood should be collected safely and in accordance with the EU Directive on Tissue and Cells 2004/23/EC and should be stored only in facilities licensed by the Human Tissue Authority.
The final advice and recommendations contains these specific points (extracted for brevity, full text can be downloaded):
Reference: RCOG Scientific Advisory Committee Opinion Paper 2 (11 page pdf)
The final advice and recommendations contains these specific points (extracted for brevity, full text can be downloaded):
- Each NHS trust or hospital ... needs to develop its own policy on how to respond to prenatal requests for cord blood storage through commercial providers, including full economic cost recovery.... we advise this policy should be made available to prospective parents at an early stage.
- There should be no alteration in 'usual managment' of the third stage (editor: of labor).
- To maximize safety for the mother and infant, collection should be made from the ex utero separated placenta.
- Collection should be made by a trained third party (that is, not the attending obstetrician or midwife) using methods and facilities appropriate to meet the European Tissues and Cells Directive.
Reference: RCOG Scientific Advisory Committee Opinion Paper 2 (11 page pdf)
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New England Journal of Medicine (NEJM) Perspective
"There is continuing competition between the two main organizations in the public bank field, the National Marrow Donor Program, based in Minneapolis, and the National Cord Blood Program of the New York Blood Center.....The National Marrow Donor Program seeks federal support for a national cord-blood program that would operate under its auspices. The New York Blood Center seeks federal support for a network of independent cord blood banks."
Final sentence: "The potential of cord-blood transplantation will not be realized until the FDA finalizes its licensure regulations and until there is a coherent, adequately funded national program to facilitate transplantation from unrelated donors."
Reference: Steinbrook, R. NEJM 2004; 351(22):2255.
"The Cord-Blood-Bank Controversies"
Robert Steinbrook, M.D., is a National Correspondent to the NEJM and contributes monthly commentaries.
Correction: Steinbrook quoted the private bank Cord Blood Registry (CBR) as having an inventory of 250,000 units. At that time, summer 2004, CBR was quoting the number of vials in storage as their "inventory", whereas all other cord blood banks quote their inventory as the number of babies from which they stored collections. Hence, a correction factor of 3 to 5 should have been used to reduce the CBR "inventory" to actual cord blood collections which can be compared to other banks. Since 2006, CBR has adopted the industry standard practice of quoting the number of baby collections as their inventory.
Final sentence: "The potential of cord-blood transplantation will not be realized until the FDA finalizes its licensure regulations and until there is a coherent, adequately funded national program to facilitate transplantation from unrelated donors."
Reference: Steinbrook, R. NEJM 2004; 351(22):2255.
"The Cord-Blood-Bank Controversies"
Robert Steinbrook, M.D., is a National Correspondent to the NEJM and contributes monthly commentaries.
Correction: Steinbrook quoted the private bank Cord Blood Registry (CBR) as having an inventory of 250,000 units. At that time, summer 2004, CBR was quoting the number of vials in storage as their "inventory", whereas all other cord blood banks quote their inventory as the number of babies from which they stored collections. Hence, a correction factor of 3 to 5 should have been used to reduce the CBR "inventory" to actual cord blood collections which can be compared to other banks. Since 2006, CBR has adopted the industry standard practice of quoting the number of baby collections as their inventory.
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Public Library of Science (PLoS) Debate
The Public Library of Science Medicine is a free-access medical journal. In Feb 2005 they published a debate titled "Can routine commercial cord blood banking be scientifically and ethically justified?"
The con side was presented by doctors Nicholas M. Fisk and Irene A. G. Roberts.
The pro side was presented by doctors Roger Markwald and Vladimir Mirinov.
Reference: Fisk, NM, Roberts, IAG, Markwald, R, Mirinov, V 2005; PLoS Med 2(2):e44
The con side was presented by doctors Nicholas M. Fisk and Irene A. G. Roberts.
The pro side was presented by doctors Roger Markwald and Vladimir Mirinov.
Reference: Fisk, NM, Roberts, IAG, Markwald, R, Mirinov, V 2005; PLoS Med 2(2):e44
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European Group on Ethics (EGE)
The European Group on Ethics in Science and New Technologies (EGE), an independant body which advises the European Commission, has issued an Opinion (no.19) on Ethical Aspects of Umbilical Cord Blood Banking.
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The EGE is in favor of public donation, because: "In all the current uses of cord blood, ... the transplantations are allogeneic and the cells used are obtained from donation" (section 1.4 of Opinion).
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The EGE is opposed to private storage, because: "The possibility of using one's own cord blood stem cells for regenerative medicine is currently purely hypothetical" (section 1.7 of Opinion).
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The EGE admits that: "if in the future regenerative medicine developed in such a way that using autologous stem cells became possible, then the fact to have one's own cord blood being stored at birth could increase the chance of having access to new therapies" (section 1.27 of Opinion).
Reference: Opinion no.19 of the European Group on Ethics (EGE), released 16 March 2004 (23 page pdf file)
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American Academy of Pediatrics (AAP)
"there is no strong evidence to recommend routine cord blood banking for an infant's future use."
Reference: Press Release, 6 July 1999
Reference: Press Release, 6 July 1999
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American College of Obstetricians and Gynecologists (ACOG)
"...it is the authors opinion that parents should not be sold this service without a realistic look at the 'return' of their investment and that commercial cord blood banks should not market their highly speculative market services as 'doing everything possible'. "
Reference: ACOG Committee Opinion 183; April,1997
Reference: ACOG Committee Opinion 183; April,1997
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Last modified: 21.January 2010
Copyright 2000 - 2010 Frances Verter
Copyright 2000 - 2010 Frances Verter