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Arxiu Frequently Asked Questions

Contents from the National Transplant Organisation - Organización Nacional de Trasplantes (ONT). Ministry of Health and Consumer Affairs

Pregunta What is umbilical cord blood and what can it be used for?
Resposta

In the past, the umbilical cord and the blood it contained were usually discarded after the birth. However, a few years ago, it was discovered that umbilical cord blood contains cells which specialise in renovating blood cells and which, if transplanted to patients with bone marrow disease, offer promising therapeutic applications.


Specifically, the main use of umbilical cord blood (UCB) is in transplants for other patients, such as those suffering from congenital or acquired bone marrow diseases, including acute or chronic leukaemia, among others. The ideal case is to find a compatible donor for the patient among their closest relatives, but this only happens in about 30% of cases.


Since the possibility of using umbilical cord blood for these patients was discovered, umbilical cord blood banks have been set up worldwide. These cords are donated altruistically and used whenever there is a compatible patient who needs them. As a result, now when it is necessary to carry out a transplant of haemopoietic progenitors (generically called "bone marrow transplants") the search for donors is carried out both for bone marrow donors and umbilical cord blood units that have been stored.


In addition, research is currently being carried out (always with the consent of the donor's mother) on UCB cells that are not usable for transplants; in the future, this research could have repercussions on the treatment of other very common diseases such as diabetes, Parkinson's or others.


There are several public UCB banks in Spain and following the approval of RD 1301/2006, it is possible that UCB banks may be authorised for autologous use (i.e. use on oneself), although none have been authorised yet.


In Spain, the Spanish Register of Bone Marrow Donors (REDMO) carries out research for bone marrow donors as well as umbilical cord blood units. In collaboration with REDMO and the UCB banks, the National Transplant Organisation coordinates the procurement and distribution of bone marrow blood from donors and the UCB units in the banks.


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Pregunta Who can donate umbilical cord blood?
Resposta

Any healthy pregnant woman going through a normal pregnancy can donate umbilical cord blood.


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Pregunta How is the umbilical cord blood extracted?
Resposta

The blood from the cord is collected at the moment of birth. Once the baby is born and the umbilical cord has been cut, the blood is collected by means of a simple prick in the umbilical cord while the placenta is still in the uterus.


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Pregunta How can I become a donor of umbilical cord blood?
Resposta

Any pregnant woman who wishes to become a donor of umbilical cord blood should contact one of the umbilical cord banks in Spain or one of the authorised maternity wards. A list of available centres can be found on the website of the National Transplant Organisation: www.ont.es.


If you have any queries, you should consult your gynaecologist about this issue.
Before the donation, you will be informed about the process and if you decide to go ahead with it, you will sign an Informed Consent document.


If you are to donate umbilical cord blood, the following steps need to be taken:


  1. A detailed clinical history of the mother, containing information of any possible infectious, haematological or any other type of disease that could counter-indicate the use of the umbilical cord blood.
  2. Carrying out a blood analysis on the mother at the moment of birth to rule out any infectious process that could be transmitted to the umbilical cord blood, especially hepatitis B and C, HIV and syphilis tests, among others.
  3. A clinical examination of the baby at birth and optionally after 3 months, carried out by a paediatrician.

Any pathological result obtained in the tests carried out for donation of umbilical cord blood will be communicated to the mother by her doctor.


The umbilical cord blood will be cryopreserved and eventually used for transplants for any anonymous patient in the world who needs it, the only condition being the best compatibility possible.


No economic remuneration or of any other kind will be given for donating umbilical cord blood.


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Pregunta Is it useful to store umbilical cord blood for autologous use (i.e. to store it for possible use in the future by the same child)?
Resposta

Many medical experts, especially experts in transplant of haemopoietic progenitors, have expressed the view that autologous storage of UCB is of little use. In addition, there are resolutions of the National Transplant Commission in Spain and even the European Commission and the Council of Europe expressing opposition or at least serious reservations about banks that store umbilical cord blood for autologous use.


Not all umbilical cord blood extracted is viable for use, as up to 20 percent will not present the necessary cells, and to this we can add a percentage that may become contaminated during the process or may deteriorate when transported. Up to 40% of the umbilical cord blood donated is not used in the end.


In addition, and most importantly, the probability that the UCB units stored could be used by the child from whom the donation was extracted is extremely low. The reason is that almost all the child transplant indications are due to genetically or congenitally caused diseases; therefore, they could be present in the umbilical cord cells and once the diagnosis has been carried out, they are not useful for a transplant to the child or to any other patient.


To date, only three cases have been recorded in the world of transplants of these umbilical cords (always in cases of acquired diseases, never congenital) in comparison to more than 6,000 transplants carried out in the world. If one of these children whose umbilical cord blood has been stored were to need a transplant for leukaemia or a congenital disease, they would have to use an umbilical cord from a public bank.


If a specialist has established the storing of umbilical cord blood for another member of the family suffering from a certain disease (targeted donation), this can be made in a public bank with the same guarantees as when the donation is made by third parties, but saved for their own family.


If anyone needs a transplant from haemopoietic progenitors in Spain, the Spanish Register of Bone Marrow Donors will be in charge of carrying out the search for the required bone marrow unit, peripheral blood or umbilical cord blood, both in Spain and internationally, offering the same possibilities as if this search were carried out from the United States or any other European country.


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Pregunta Can I save my child's cord blood for autologous use (i.e. save it for possible use with the same child)?
Resposta

RD 1301/2006 acknowledges parents' capacity to save their child's umbilical cord blood (UCB) for eventual autologous use. In Spain, to date, there is no authorised UCB bank for autologous use, but you can send your child's UCB to a bank abroad, as long as the conditions specified in the aforementioned Royal Decree are met.


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Pregunta Can I take my child's umbilical cord blood out of Spain?
Resposta

As stipulated in RD 1301/2006, you can take your child's umbilical cord blood (UCB) out of Spain whenever you want, as long as it complies with the following conditions:


  • The centre where you child was born must be specifically authorised to extract UCB.
  • The UCB bank where your child's UCB was sent must be authorised to store it.
  • There must be an agreement between the maternity ward where you child was born and the bank where your child's UCB was stored.
  • In addition, if the bank where your child's UCB is to be sent is outside the European Union, you must apply to the National Transplant Organisation for an authorisation to take your child's UCB unit out of Spain

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Pregunta If I have to request permission from the National Transplant Organisation to take UCB out of Spain for autologous use (i.e. for storage and eventual use with the same child), how is the request made?
Resposta

If your child's UCB unit is going to be sent for storage in a UCB bank outside the European Union, the maternity ward must apply for authorisation from the Director of the National Transplant Organisation for the unit to leave Spain. This must also be accompanied by:


  • A certificate or document proving that the UCB bank your child's UCB is going to be sent to for storage is authorised for this activity.
  • A certificate or document proving the existence of an agreement between the maternity ward where your child was born and the UCB bank where your child's UCB is stored.

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Pregunta Can I save my child's cord blood for autologous use (i.e. to store it for possible use for the same child) in Spain?
Resposta

Currently no bank is authorised for this purpose in Spain; however, as soon as any of these banks is authorised, you will be able to store your child's UCB as long as the following conditions are met:


  • That the centre where your child was born is specifically authorised to extract UCB.
  • That there is an agreement between the maternity where your child was born and the bank where your child's UCB is to be stored.

In addition, you should know that all UCB units stored in these types of banks are at the disposal of the Spanish Register of Bone Marrow Donors (REDMO) and can be used to treat any patient needing a UCB transplant and compatible with any of the UCB units stored.


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Pregunta What requirements does an umbilical cord blood bank have to comply with to be authorised for eventual autologous use?
Resposta

For a UCB bank of these characteristics to be authorised, it must comply with the following conditions:


  • It meets the requirements specified in points 2 and 3 of Annexe I of RD 1301/2006.
  • It carries out its activities in a non-profit manner, as well as the rest of the cell and tissue establishments.
  • It maintains the same standards of quality in obtaining, processing and storing as public UCB banks.
  • It can ensure that if its operations cease, the UCB units stored will be transferred to another bank with no risk of loss or deterioration.
  • It places at the disposal of the Spanish Register of Bone Marrow Donors (REDMO) all the units stored, so they can be used to treat any patient needing a UCB transplant who is compatible with any of the units stored in the bank.

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