Stem Cells, Umbilical Cord Blood Banking and Transplantation
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Nowadays, there are many alternatives or any other methods to improve the healthcare especially in a transplantation world. There are few choices available for the people today such as the embryonic stem cells, bone marrow stem cells, peripheral blood cell and the most new is the umbilical cord blood. The umbilical cord blood (UCB) defined by Chima and Mamdoo (2011, p. 79) as the blood which taken from the cut umbilical cord attached to the placenta of a newborn baby after a delivery. It been stated (Chima and Mamdoo 2011, p. 79) that the cord derived from the allantois have a rich source of multipotent stem cells, including the CD34+ , CD38- and haematopoietic progenitor cells. This shows that the cord blood could be more potential as the bone marrow cell in the patients with the haematological or non-haematological problems. The first successful umbilical cord transplantation done was in 1989 in a child with a Fanconi’s anemia and since then, the growth or demand for the cord blood increased. As we can see, this contributed to a major reason for the need of umbilical cord blood donation, storage, processing, freezing, and releasing of cord blood to the patient. Thus, establishment of the cord blood bank (CBB) because of the demand increased (Ballen 2010, p. 8). As mentioned by Ballen (2005, p. 3786), the first establishment of cord blood bank was in the early 1990s in New York, Milan, and Dusseldorf. The storage of the cord blood could last for about 15 years (Fadel 2006, p. 1). The point is that there are many ethical and legal issues raised by this CBB that need clarification and justification like the informed consent, ownership and property rights, collection of cord blood, and public CBB vs private CBB.
As mentioned earlier, there are issues on informed consent but what is actually the informed consent is all about and what is the thing that need to be considered for this cord blood banking. Firstly, what is mean by informed consent is the permission given from someone of one behalf to another behalf. According to Petrini (2010, p. 140), there were some kinds of elements of process leading to informed consent found by Beauchamp and Childress. The first one is the threshold elements (preconditions) which to understand and decide. Second, the information element, which means to make things clear or clarify the information given, the good recommendation of plan and to understand the previous elements.
Third, the consent itself means to give a decisions and permission but it is said to become problematic when all this three elements been implemented in the context of cord blood collection, storage and use. This is because the issue on the ownership of the cord blood had raised.
First of all, (Petrini 2010, p. 141) had constructed some of basic question need to be answered as the outline or guide for consent. The questions are as follows; i) Which person has the right to give consent?, ii) What is the matter of the consent?, iii) How should consent be obtained and given?, iv) Who is qualified to accept the consent? and v) When should consent be given?.
The answers based on Petrini (2010, p. 141) is that the one who normally and can gives the consent is the mother on behalf of her baby not consent for herself because the cord is said to be the belonging of the baby. The involvement and cooperation of the father in giving a consent is highly recommendable (Petrini and Farisco 2011, p. 293). Next, it is very important to ensure the content of the consent not just only for the collection and storage of the cord blood but also for its possible uses. After that, the mother should be adequately informed with the clear infromation and the consent is not taken in a hurried situation but in a very convenient and comfortable form like in a written form. Then, the one who qualified to accept or reveice the consent given are the nurse, the medical doctor or the hospital administration. Lastly, many possible answers available on when the consent is suitable to be asked and given such as on the occasion of a medical examination during the pregnancy, at the moment of childbirth, and at the moment of hospitalisation. A request of consent just before childbirth should be prevented or avoided because this informed consent needs adequate reflection from the mother. Secondly, it is said to be careful of bureaucratisation (Petrini 2010, p. 141).
Lastly, the problem related to the personal data protection also connected with informed consent and for example the Belgian Advisory Committee on Bioethics had been taken into account on this matter. According to Fadel (2009, p. 5), the mother have to be consulted or provided with a very clarify information about the utility or use of the cord blood donation. Besides that, she need to be informed about the pros and cons of the cord blood bank available which are the public or the private bank. Again, both parents are responsible in making a decision for the cord blood donation and it does not matter whether it is a muslim countries or not because the parents are the custodian of the baby.
Some women want to be informed earlier during pregnancy about all the information on cord blood easy for them to make a decision because they need to understand about it matter properly. In addition, studies shows that women is likely and prefer to have a health professional as a source of information (Bordet et al, 2007).
As mentioned by Navarrete and Contreras (2009, p. 237), most CBB in Europe had taken the consent just after the collection is obtained successfully at the beginning. After that, based on the European Union Tissues and Cells Directive (EUTCD) 2004/23/EC in April 2006, the collection of the cord blood is only been taken after the consent is obtained and the authorization requirements is met. Normally, the consent is obtained when the mother attend the hospital at around 30 weeks (9 months) of pregnancy via somewhat called ‘mini consent’ by filling a form before entering to the labor room. This ‘mini consent’ was very helpful and it increased the efficiency of cord blood collection by reducing the wastage of cord blood due to lack of consent (Kidane et al, 2007). The mother have to be informed clearly about all information regarding the process, collection, risk, pros and cons by using her language or the languange that she can understand to have a better understanding (Navarrete and Contreras 2009, p. 237).
In the first points, the issues of ownership had been mentioned earlier but now the issue will be clarified more together with the property rights. The issue of privacy and confidentiality also will be touched a little bit here. As it had been stated by Chima and Mamdoo (2011, p.80) that this issue raised and been debatable is because the cord blood is embryologically and originally comes from the allantois of the fetal so it might be considered as the baby’s property. Apart from that, under the English law the cord is considered as the mother property’s once and after the cord is cut ( the placenta still remain in the mother until the blood being extracted from the maternal side of the cord clamp). It is said that the mother is the owner of everything afterbirth in the Royal College of Obstreticians Advisory Committee Opinion Paper 2 (Smith 2008, p. 241).
There are the establishment of the property law by the courts in United Kingdom and Australia. This law becomes a challenge to one who see this cord donation as a form of a gift which is given without any payments or conditions. In other words, the property law recognize that gift can be made conditionally in the ways that preserve the rights of control and access for the donor. This law could be very beneficial to regulate cord blood banking because it creates a languange for understanding conditional donation. Next, the property law also shows how the relatives can do a payment for the cord blood in the private bank (Stewart et. al 2013, p 291). In many cases of the private bank normally the ownership is given to the child once they reached a certain age but the ownership falls since birth in English and South African Law. It been said that the fetus which is born and lives ex-utero becomes a legal person to acquire all the rights. The child is recognised as a legal person by all national laws. However, the baby does not have the capability to give consent (Chima and Mamdoo 2011, p. 80 ; Petrini 2010, p. 141).
As argued by Chima and Mamdoo (2010, p. 82), the confidentiality and privacy of all records of UCB donor and recipient need to be well kept or protected by the law. If any kinds of abnormality in genetic or infection is identified during testing, the test results must be send to the donor or parents or guardians in a very appropriate manner and a suitable counselling should be provided according to the severity of the abnormality. A consideration should be given for the patient to choose an option for disclosure of abnormal results due to respect on the autonomy of the patient and basically related to freedom of choice. Next, there is also a case which the UCB is linked to the donor which have a high potential to expose the mother’s ‘private history’ when the medical information pathway about the child is created through screening. As a results, the best policy for the storage of a non-autologous UCB in conjunction with privacy is by completely de-identification of the samples as been suggested, so it could be freely tested without any simultaneous testing of the mother and child. Besides that, there are loss or misuses of the information especially in the commercial cord bank. It could be devastating to the child’s right and privacy ( Smith 2009, p. 242).
Other things need to be considered and taken into account in the cord blood banking is the collection of the cord blood itself. The collection of the cord blood is only happened after the consent is obtained ( Stewart et al, 2013). According to Laskey et al (2002) cited in Ballen (2010, p. 11), the collection of the cord blood can be collected in utero which is done before the delivery of the placenta by the midwife. The other collection is ex utero method which is less invasive and more controlled but it is more expansive because it needs an extra trained personnels. The ex utero is performed by suspending the placenta, followed by cannulating the vein and finally allow the blood to drain by the force of the gravity into a specially designed UCB collection bag (Armitage et al 1999a, cited in Navarrete and Contreras 2009, p. 237).
Next, the controversial issue regarding the washing of the cord blood unit had became necessity prior to infusion that had raised. This is because in the earlier studies reported that a post-thaw cord blood dextran albumin based washing is very essential to preserve the cord blood progenitor cell viability and to make the engraftment faster. Recently, the clinical studies show that post-thaw cord blood dilution without washing or the thawed cord blood through a direct infusion is associated with equally reliable engraftment and free from side effects (Chaw et al 2007, cited in Ballen 2010, p. 11).
According to Laskey et al. (2002), cited in Navarrete and Contreras (2009, p. 237), the ex utero method have a minimal risk to the mother and the infants but still the risk of contamination of microbial might be higher. There are also studies show that the collection by in utero yields a very large volume and larger total nucleated cells as compared to the method of ex utero. Actually, there are no such a huge difference in volume between both method when the appropriate trained staff in involved in the collection process as shown by a recent study. The ex utero method is very highly recommended because the safety of the mother and child are highly protected as said by both the UK Royal College of Obstretricians and Gynaecologists (2006) and the Royal College of Midwives as cited by Navarrete and Contreras (2009, p. 238). Next, the National Health Services Cord Blood Bank (NHS-CBB), which known as London Cord Blood Bank before aim to enrich the international hematopoietic stem cells (HSC) donor pool with units from the ethnic minorities but the volume and total nucleated cell (TNC) content of the units is smaller than the requirement volume which is 40ml. (Ballen et al, 2004; Ellis et al, 2007, cited in Navarrete and Contreras 2009, p. 238).
Again, the collection of cord blood by ex utero should be made and a third party which not the obstetrician or midwife are the one who should do the collection task and should meet the concerns of the European Tissue and Cells Derivative. After that, collection of the cord blood should not been done if there are any contraindications such as the preterm deliveries, nuchal cord, or maternal hemorrhage (Rajab and Sequeira 2009, p. 179). Lastly, as argued by Edozien (2006, p. 802), the collection of cord blood also cannot be collected during complicated deliveries and during the multiple pregnancies because this events can contributed to error in labelling the cord blood unit (CBU) and cross contamination also might happen which gives a serious impact especially in non-identical twins. The lower nucleated cell counts is results from the preterm deliveries (Wagner et al, 2000, cited in Edozien 2006, p. 802).
Maternity units have an ethical obligation to help in minimizing the risk of infection in CBU collection. In order to perform the obligation, the unit that collect the cord blood should first screen the mother for infection, including the history of travelling in oversea, exposure to live viral vaccines and the use of the recreational drugs. The very good quality of the cord blood is not just concern on the collection only but also concern in the processing and the storage as all this plays a big roles. Each cord blood banks must fulfill and meet the specified standards regarding the process and storage of the cells (Edozien 2006, p. 802).
The last thing that will be discussed here is the issues of the public CBB versus the private CBB. There are plenty of things could been talked about this issues. Some of the parents got confused and want a very clear picture about both of this CBB because they still do not know where to donate their cord blood. In my opinion, to decide which bank should be selected is by looking forward to the main purpose of donating the cord blood, to whom the cord blood want to be donated, the characteristics of both banks and the main thing is to look at the ability to pay for the fees. The public bank provide a free of charge services to store the CBUs while the private or commercial CBB asked for a payments. Basically, this CBB is supported or financed by the public money or government (Katz G et al, 2011 cited in Alkindi and Dennison 2011, p. 457).
Usually, the public banks stored the cord bloods for the public use especially for the allogeneic transplant programs (unrelated donor), for some types of research and for any patient without a donor while the private or commercial CBB focused on the autologous treatment (related donor) for the child donor (Stewart et al 2013, p. 292). According to Querols (2012, p. 185), the aim of the private CBB is to kept for the familiar use. Apart from that, this is a profit organisation whereby the cost is paid or covered by the donor itself. Public CBB usually connected with the local network hospitals which then send the cord blood to the central processing facility. In addition, the public bank also receives CBUs from any providers through a shipment via overnight express couriers. Next, the public CBB had a strict regulations and each CBUs collected must fulfill the standard requirement (Fadel 2009, p.3). As mentioned by European Group on Ethics in Science and New Technologies (2004) cited in Fisk et al (2005, p. 44) the European Union had highlighted the concerns regarding the private bank that selling service with no real use and usually more UCB became a wastes. As summarised by Chima and Mamdoo (2011, p. 81), the collection of UCB is performed by the trained personnels at a selected hospitals. Meanwhiles, in the private CBB the cord blood is collected by the third party which my be the untrained personnels because the private CBB might give them incentives. Lastly, about the quality assurance in both CBB. The public CBB have a good regulation to the quality standards but te private CBB not always connected to the International groups certifying the adherence to quality standards.
As a conclusion, cord blood is taken from the umbilical cord of the newborn after the cord has been detached from the baby. This cord blood banking which used as a storage for the transplantation is more potential as compared to the bone marrow transplantation had promoted to the establishment of the cord blood bank. After that, this CBB have given a pros and cons but there still an ethical and legal issues which should be taken into consideration. The ethical and legal issues that been discussed earlier are the issues of informed consent, ownership and property’s right, collection of cord blood and public vs private CBB. Plenty of concerns should be clarified in order to get a consent in such a very proper manners. For instance, the person who should give the consent and what consent is given. Next, the time for the cord blood collection should also be suitable like before the labor and delivery (Petrini and Farisco 2011, p. 293) . Then, the issue of ownership and property’s right which discussed about who owns the cord blood and the mother is responsible in ensuring the blood until the child reached a certain age (Smith 2009, p. 238). Next, the issue regarding the collection of cord blood. It is highly recommend that the cord blood is collected by using the ex utero method as it is more safe to the mother and child. Last but not least, the issue of the public CBB vs private CBB. The public CBB is establish in accordance to the public use and the allogeneic transplant. Meanwhile, the private bank is a profit based bank and use for the autologous transplant. Finally, both of this cord blood should be encouraged by many people whole over the world especially the public CBB to help more people.
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