Position Statements: Umbilical Cord Blood Banking
There are at present at least three commercial units in South Africa who offer mothers the opportunity to store long term the umbilical cord blood stem cells of their babies. These units can then supply the stem cells at a later date, in case that child or his/her siblings develop a condition that could only be treated by stem cell transplantation. In the majority of the current uses, the transplantations are allogeneic and the cells used are obtained from donation. The use of autologous transplantation would be inappropriate in patients with a genetic disease, as the cell of the patient would carry the same genetic defect, a scenario encountered in a number of types of leukemia with a chromosomal translocation. In the case of allogeneic transplantation there is always the risk of “graft vs host reaction” and hence HLA-typing is essential to optimize HLA matching between donor and recipient. The concept of autologous use of umbilical cord blood is still a recent technique and although there is a large amount of speculative information about its possible use, only a few cases have been documented. Most indications for autologous transplantation concern adults who have undergone bone marrow aplasia following chemotherapy or radiotherapy. As stated previously, the aim of the transplantation is to repopulate the bone marrow with own haematopoietic stem cells which will provide a source of blood cells. Such autologous grafts however do not necessarily require one’s own umbilical cord blood stem cells to have been stored at birth. Stem cells can be obtained from one’s own peripheral blood, following stimulation with growth factors, prior to instituting the chemo-radiotherapy, and then transfused later.
Recently a significant amount of advertising and marketing of these commercial storage units has taken place in South Africa. Advertising leaflets are being distributed to antenatal clinics, to units specializing in assisted conception and to consulting rooms of medical attendants. A plethora of promotional literature appears in women magazines and on the internet. Doctors as a result, are being continuously confronted by parents who request information or an opinion whether cord blood from their baby should be collected at the time of delivery and transported for storage in privately owned units. Despite all the advertising and marketing campaigns taking place, the impression among some medical attendants is that we know what might be possible in the future regarding stem cell research, but we do not know exactly what will develop.
With this dilemma in mind, SASOG has put together this statement to help obstetricians, midwives and other health care professionals, who are faced with questions from patients relating to stem cell storage. This statement is aimed at providing information based on scientific facts, current clinical use, safety and legal implications of collection, the dilemma between personal and altruistic cord blood storage, whilst still keeping in mind the many speculative uses for stem cells that may occur in the distant future.
UMBILICAL CORD BLOOD STORAGE
A. NON DIRECTED DONATIONS
In this situation, patients are recruited for altruistic donation of cord blood. This cord blood is processed, HLA typed and stored in a public stem cell bank. It is available for clinical use in any suitable recipient worldwide. The use of allogeneic haemopoietic stem cell transplantation is limited by the need to find an HLA-compatible donor. For those patients who need a bone marrow transplant with no suitable family member, unrelated donor cord blood banks have been set up alongside registries of bone marrow donors to facilitate matching, in order to use cord blood stem cells. The NETCORD FOUNDATION was established in 1998 with the aim of promoting the use of umbilical cord blood for allogeneic stem cell transplantation. It is a non-profit organization promoting the establishment of high quality umbilical cord blood banks and has issued standards and guidelines in order to further promote studies and research on the collection, processing, characterization, preservation and ex-vivo expansion of placental blood. It also provides a search mechanism and currently has over 85 000 preserved cord blood samples available for clinical use. There is little or no controversy surrounding these donations.
B. DIRECTED DONATIONS IN “AT RISK FAMILIES”
The logic here, is that cord blood obtained from an unaffected child might be useful in a currently affected, or a future affected, sibling in the family with a high risk of certain diseases. If the cells are HLA compatible, they may be used for the affected child. If not, they may be usable for a future HLA compatible sibling. If a newborn child itself develops the disease, its own umbilical cord stem cells may be usable in future, when new techniques are developed that can overcome the genetic disease. Bearing in mind that HLA compatibility may not be present in the affected sibling and that alternative therapies, be they chemo- or radiotherapy, do exist for many diseases, there are some questions regarding these donations. However, no major controversy exists and many experts strongly advise the need for these donations in families affected with genetic diseases.
C. DIRECTED DONATIONS IN “LOW RISK FAMILIES”
This is the market that is presently being targeted by the privately owned commercial stem cell banks and where perhaps the greatest controversy exists. It is difficult at present, with the available data, to estimate the likelihood for directed donation in a low-risk person being used by the individual who had stem cells stored from their umbilical cord. The chances of using personal cord blood for haemopoietic disorders before the age of 20 years is low and estimates vary between 1 in 2 700 to 1 in 20 000. Future use for conditions such as neurological, cardiac and degenerative disease, is at present, purely speculative.
Arguments against this form of stem cell sourcing and storage in commercial units include the low probability for autologous use, the possibility of alternative forms of therapy, allogeneic transplantation through international cord blood banks, bone marrow registries being available, and the fact that autologous stem cell transplantation will not be appropriate in conditions where the disease has a genetic origin.
Societal support for this type of stem storage is lacking and in fact in some countries is forbidden. THE EUROPEAN GROUP ON ETHICS IN SCIENCE AND NEW TECHNOLOGIES do not obviously support this form of stem cell storage. In 2004 they advised the EUROPEAN COMMISSION that “the legitimacy of commercial cord blood banks for autologous use should be questioned and recommended if cord blood banks were to be established, they should be from altruistic and voluntary cord blood donation and used for allogeneic transplantation in related research. Promoting donation for autologous use and the establishment of cord blood banks for autologous use should not be supported by member states or their health services. Activities of such banks possibly raise serious ethical criticism. Accurate information about the advantages and disadvantages of cord blood banking must be regarded as a priority, and where autologous cord blood banks were being established, the publicity and information provided to families must be accurate. They emphasized that any advertising must be adequately controlled by public authorities, and recommended that support for public cord blood banks for allogeneic transplantations should be increased”. In Italy, private banking of stem cells is forbidden.
In 2004 the Royal College of Obstetricians and Gynaecologists set up a panel of experts to consider issues surrounding umbilical cord blood collection and banking. The panel included experts from various medical disciplines, as well as experts from law and ethics. Their advice and opinion was published in June 2006 and the full report can be found on the RCOG website website www.rcog.org.uk.
The panel considered collection of non-directed donations and directed donations for “at risk families” acceptable procedures through established public sector cord blood banks, although they felt there is still insufficient evidence to recommend directed cord blood collection and stem cell storage in low risk families. In essence, they felt that low risk families who banked their umbilical cord blood could be wasting their money, as the likelihood of them ever requiring the cells are very low. As stated by others, they also felt that the concept of utilizing the stem cells for non-haematopoietic indications is still speculative, but that it is understandable that some patients, who can afford to do so, may wish to avail themselves of commercial services offered. Emphasis again was placed on the fact that patients must be fully informed of their rights and financial obligations once registering with commercial providers. Patients must be made aware of all the details pertaining to their obligations early in their pregnancy so that they can discuss the issue with their medical attendants, should they wish to do so. Parents-to-be need to have all the details made available to them so that they fully understand the implications of their final decision.
In order to successfully obtain the stem cells from the umbilical cord, there should be no alteration in the usual management of the third stage by either the attending medical doctor or nursing staff. Commonly, it is safe and appropriate, to collect the cord blood with the placenta still in-utero. However should the necessity arise, then collection should be made from the placenta only after it has been completely delivered, an exercise to maximize safety of the mother and infant. In general it would be acceptable that the attending doctor or the nursing staff is responsible for obtaining blood from the umbilical cord, however collection may have to be through a trained third party. The service should not be made available in cases where the attending clinician believes it to be contra-indicated. This may include patients who have premature birth, an associated nuchal cord or maternal hemorrhage at the time of the delivery.
The sentiments of the panel were primarily to support development of an infrastructure which would implement public sector non-profit storage banks for unrelated non directed cord blood banking, directed donations for families with genetic disorders or for families with a member with an acquired disease treatable by haematopoietic stem cell transplantations. This would ensure, or at least provide, a broad coverage and equitable access for those in need of the benefits of stem cell transplantation. Irrespective of implementation, the RCOG recommends that research continue in the field of stem cell therapy. Having said all this, however, it is important to bear in mind that a public stem cell bank does not exist in Southern Africa, and in reality, the cost of establishing such a bank will be expensive and costly to the health department. The costs arise from performing all the necessary maternal blood tests, HLA-typing and the need for long term storage. It may need the government to levy a tax on all private collections stored in South Africa and monies obtained in this manner directed towards the development of the public bank. Alternatively, private stem cell banks could donate a percentage of their revenue to establish such a bank.
SASOG acknowledges that facilities for private cord blood banking are available in South Africa and are actively being marketed at present. However we also believe that it is the responsibility of these storage banks to educate parents-to-be on the advantages and disadvantages of umbilical cord banking in a totally unbiased manner. It is at present very expensive to store umbilical cord blood in private cord blood banks, and the likelihood of ever requiring the cells is still very low. SASOG strongly recommends that patients do not compromise themselves financially in order to store the cord blood. Private cord blood banking cannot be recommended as a routine for everyone and every effort should be taken by the profession to alay any parental guilt that may be generated by advertising. The prospect of having a baby is a particularly sensitive time for parents, and the concern is that some parents may feel emotionally blackmailed into accepting the need to store the cord blood. Any negotiations that the parents may enter into must be based on unbiased education and awareness. The issue of storing umbilical cord blood from patients who are “low risk” is essentially one of affordability and insurance. Parents-to-be must understand that should they need the stem cells, of which the chances are remote, they are available, however if they never need the cells, which is highly likely, they have wasted their money.
SASOG is in favour of freedom of choice and if patients have the resources and wish to store their baby’s stem cells, the profession should comply with their wishes provided that there are no contra-indications and that the safety of the mother and baby are always the priority during labour. It is critical that all cord blood banks process and store the umbilical cord blood in accordance with recognizable international and medical accreditation standards. This gives assurance that the cells are properly processed and stored. The expectation being, that all the appropriate steps have been taken to ensure that the cells will be viable, if and when they are required.
The website that parents-to-be may use, which has been designed specifically for advising them on cord blood banking, is www.parentsguidecordblood.com. This website provides a list and comparison of all private stem cell storage banks across the world and also provides parents with a list of recommended questions they should be asking storage companies.
The website also provides references to all the various organizations that support and oppose umbilical cord banking.
PROF F GUIDOZZI
President,
SASOG
