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Cord Blood – Preservation A Guide for Parents, Ministry of Health

Cord Blood

After the baby is born and separated from the umbilical cord, blood remains in the blood vessels of the placenta and in the section of the umbilical cord that remains attached to it. This blood is called cord blood, or for short – cord blood.

Cord blood is rich in hematopoietic stem cells, which can be transplanted into patients with blood diseases and diseases of the immune system.

The decision to donate your infant’s cord blood to a public cord blood bank or keep it in a private cord blood bank, if any, is personal and free.

What is umbilical cord blood?

Cord blood contains red blood cells, white blood cells, platelets, and plasma. In addition, cord blood is rich in circulatory system stem cells (hematopoietic stem cells) and is similar to bone marrow. There is the ability for hematopoietic stem cells to develop into many different types of blood cells. During life, it divides and regenerates different types of blood cells according to need.
These cells constitute the source of three classes of blood cells:
  • Red blood cells that carry oxygen throughout the body.
  • White blood cells are part of the immune system and are involved in protecting the body from infectious diseases and foreign agents (bacteria, viruses, parasites, foreign particles and tumors).
  • The participation of platelets in the physiological process of stopping bleeding (coagulation).

Why is cord blood used?

Every year, thousands of people are diagnosed with diseases of the blood and immune system (such as multiple myeloma, leukemia, lymphoma, myeloproliferative neoplasm, thalassemia, immunodeficiency, etc.) which can be treated by hematopoietic stem cell transplantation. These stem cells are obtained most often from bone marrow donation, while in other cases for which it is not possible to find a suitable donor – from umbilical cord blood. The cells are transplanted intravenously and entered into the bone marrow, where they are divided and classified into healthy mature blood cells. Cord blood stem cell transplantation is a method that has been in use since 1988.
The success rates of cord blood transplantation in children for the purpose of hematopoietic system rehabilitation (bone marrow transplantation) are similar to the success rates of hematopoietic stem cell transplants from other sources. In addition, there is an increasing use of cord blood transplantation in adults and continued improvement in outcomes.
Hematopoietic stem cells from another person (either a relative or a stranger) can be transplanted. A transplant of this type is called an allogeneic transplant. Alternatively, the transplant can be done using the patient’s own hematopoietic stem cells, called an autologous transplant.
As mentioned, bone marrow and peripheral blood stem cells are collected from living donors, who are often family members, or foreign donors who have volunteered for fitness screening and are registered in international bone marrow donor databases.
As with any complex treatment, the use of umbilical cord blood for the purpose of bone marrow transplantation has advantages and disadvantages, and the doctor who will perform the transplant must recommend the most appropriate solution for the patient, after considering the opportunities, risks, and possibilities available in relation to the same patient.

Advantages of using umbilical cord blood

  • It requires a lower level of tissue matching (HLA) between the donor and the recipient compared to a stem cell transplant from bone marrow or peripheral blood, and therefore there is a lower risk that the patient will develop “graft versus host disease” (GvHD). That the donor cells attack the patient’s body.
  • Cord blood meals are stored and immediately available in case the patient needs a transplant urgently. But a bone marrow meal is not immediately available and requires a procedure that includes a number of steps. The procedure for donating bone marrow and peripheral blood stem cells only begins with a special request.

Disadvantages of using umbilical cord blood

  • Since cord blood meal has fewer cells compared to stem cell meal which is sourced from bone marrow or peripheral blood, hematopoietic system recovery is slower and as a result there is a greater tendency for infection.
  • Absence of the possibility of giving the patient white blood cells of the same type of lymphocytes after transplantation, which can improve the results of transplantation in certain cases.
  • Cord blood cannot be used for transplantation in cases where the donor baby (where the umbilical cord blood was collected at birth) has been reported to have a genetic disease.

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Cord blood donation in public cord blood banks compared to private preservation

Donate to a public cord blood bank

Cord blood banks collect, transport and store umbilical cord blood meals for the benefit of the general population of patients who may need stem cell transplantation.
  • The donation to a public cord blood bank is made for the benefit of the general public and has a real life-saving potential for every person for whom the meal will be appropriate. This is a source of hope for patients for whom we do not find a suitable bone marrow donor within their families or in international databases.
  • During the past two decades, far fewer than 1,000 cord blood autologous cell transplants have been performed in the world, compared to more than 30,000 cord blood transplants from foreign donors who donated to public cord blood banks, as an alternative to bone marrow transplants.
  • Many international organizations in the world and certain regulatory bodies oppose the trade in preserving umbilical cord blood in private banks. Instead, they promote and encourage altruistic donations of cord blood to public cord blood banks, which have saved thousands of lives worldwide.
  • A donation of cord blood to a public bank contributes to international human solidarity, and is the most effective way to preserve stem cells from cord blood. These cells will be available to patients suffering from diseases and medical conditions that are known to have no other solution, which is why they are saving lives
Preservation in a private cord blood bank
Private cord blood banks hold cord blood meals for newborns and only intended for use by them or their family members.
  • It is important to know that in some diseases, such as types of leukemia, the use of a cord blood meal is not recommended, due to the risk that cells in the cord blood already contain disease agents.
  • It could be a case where a meal kept in a private bank would be unsuitable for hematopoietic transplants if they needed it when needed, due to the quality of the meal.
  • Currently, any use of cord blood that is not intended for hematopoietic stem cell transplantation is in the stages of basic research or clinical trials. Private banks that keep meals for family use deploy possibilities for future use to treat a variety of diseases such as diabetes, heart disease, cerebral palsy, autism and more. To date, there is not enough evidence to support these claims. Perhaps in the future, it will be possible to treat these diseases in additional innovative ways, not only with cord blood cells but also with stem cells from another source. At the moment there is no knowledge about the requirements that these cells have to meet (type of cells, number of cells, etc.) and the true potential for their use for these purposes.
  • If cord blood is kept in a private bank, it will not be possible in the future to transfer it to a public cord blood bank for the benefit of the general patient population.

​Supervision of public and private cord blood banks

In Israel, the Ministry of Health is the supervisor of cord blood banks (public and private), and issues operating permits to banks that meet the requirements.
Public and private cord blood banks must meet the safety and quality requirements stipulated by law, regulations and procedures. The fulfillment of the requirements is checked during the supervision carried out by the Ministry of Health.
It is prohibited to operate a private or public cord blood bank in Israel for anyone who has not obtained a valid operating permit and certification from the Ministry of Health of meeting professional and legal requirements (compliance approval).
If a private cord blood bank transfers cord blood meals for preservation outside Israel, the permit from the Ministry of Health refers only to the stages of handling the meals that were carried out in Israel. The Ministry of Health does not supervise cord blood banks and sites outside of Israel.
*The list is updated from time to time.

Cord blood banks for public use

Public cord blood banks collect, transport and store cord blood meals for the benefit of the general population of patients who may need stem cell transplantation. Public banks store cord blood meals donated by the newborn’s parents for the use of any patient who needs them. Parents do not pay for the collection and do not receive compensation for the donation.
As long as the cord blood meal is available in the bank, it can also be used by the donor (the newborn), if he has an illness that requires a stem cell transplant and will need an autologous stem cell transplant. However, in most cases cord blood cannot be used for a child with circulatory disease, because there is a risk that the cord blood cells already contain the disease agents.
Parents must sign an informed consent form providing the bank with permission to record the meal in a global database, where a search can be made for meals that will suit patients awaiting transplantation. The cord blood meal is recorded in a global HLA database only, without any information on the identity of the donor. Success in finding suitable donors depends on the number and variety of servings available in the databases. The reason the databases are global is in order to increase the supply of available meals and the chances of finding the most suitable donor for any patient who needs a transplant.
In the cord blood bank, only meals containing a sufficient number of cells are preserved for transplantation according to the latest requirements in the field of transplantation. Cord blood meals collected in the hospital, are transported to the bank and undergo rigorous and stringent quality and safety tests.
Only about -40% of the collected meals were found suitable for preservation . Meals that did not meet the requirements for quality and safety were excluded. A meal was left out, among other things, due to one of the following reasons:
  • Low cell count and unsuitable for hematopoietic transplantation;
  • Presence of pollutants originating in the collection or treatment process;
  • Reduced cell life, due to collection, transport or processing.
Each collected meal is marked with a single-valued diagnostic number.
Each cord blood meal found to meet the requirements is frozen for long-term preservation in a public cord blood bank and stored in a freezer at -1960C.
As mentioned, a meal kept in a public cord blood bank is recorded in the global database (without any diagnostic details of the donor) and is available for use for the benefit of anyone who needs it, all over the world. Patients from Israel can also get a cord blood meal from other countries in the world that have cord blood banks.
Activism in Israel emphasizes collecting meals that represent all communities and ethnic minorities in the country. This policy aims to increase the chances of finding suitable meals for patients in the country.
Procedures accompanying the donation
After receiving explanations, the mother is asked to sign an informed consent form.
The mother should answer questions about her medical history and other family members of the newborn, related to hereditary diseases such as thalassemia, and exposure to infectious diseases such as hepatitis, HTLV, HIV and syphilis.
Also, the mother should give a blood sample to be tested for the absence of infectious pathogens (such as hepatitis, HIV, HTLV and syphilis), according to the updated guidelines on this subject.
In the event that one of the test results is positive, the mother will receive a notification and direct medical advice.
If, God forbid, an illness or a serious illness is diagnosed in the newborn, the mother is required to report this to the cord blood bank, in order to prevent the process of transplanting a cord blood meal with the potential to cause serious illness in another person.

​Factors that affect the ability to donate cord blood to a cord blood bank

​The decision to donate cord blood for the public good is a personal decision of the mother and father of the newborn (to the extent of his knowledge, and if there is a reasonable possibility of identifying him, to find him or know his opinion at the time). It is important that this decision is based on reliable information and professional advice from a professional in this field such as the attending physician.

After making the decision to donate cord blood to a public blood bank, please contact a public cord blood bank in Israel, for further instructions.
Due to system limitations, a consent form to donate cord blood is often required to be signed very close to the time of delivery. Despite this, it is important to remember that donating cord blood should be done voluntarily by the mother or by decision of the parents and without pressure . Refusal to donate does not cause any harm to the rights of the mother or treatment for her and the newborn. Parents may revert to this at any point in their willingness to donate cord blood, before the meal is collected and up to 24 hours after.
Private Births :
  • Cesarean section – In principle, umbilical cord blood can also be donated in caesarean section deliveries. The collection policy for caesarean section varies between public cord blood banks and it is therefore advisable to check the bank’s policy before delivery.
  • Surrogacy/surrogacy – requires the consent of the mother (pregnant mother – surrogate) for the cord blood collection. It is the intended parents (who will grow/bring the child) who will decide whether the cord blood can be donated to a public bank, kept privately or not at all.

Procedures accompanying the donation

  • After receiving explanations, the mother is asked to sign an informed consent form.
  • The mother should answer questions about her medical history and other family members of the newborn, related to hereditary diseases such as thalassemia, and exposure to infectious diseases such as hepatitis, HTLV, HIV and syphilis.
  • Also, the mother should give a blood sample to be tested for the absence of infectious pathogens (such as hepatitis, HIV, HTLV and syphilis), according to the updated guidelines on this subject.
In the event that one of the test results is positive, the mother will receive a notification and direct medical advice.
If, God forbid, an illness or a serious illness is diagnosed in the newborn, the mother is required to report this to the cord blood bank, in order to prevent the process of transplanting a cord blood meal with the potential to cause serious illness in another person.

​Maintaining a personalized cord blood meal

If in the newborn’s immediate family there is a patient who may soon need a bone marrow transplant, it is possible to request that a “dedicated donation” be preserved in the framework of the health basket.
The service is in the health basket for families in which there is a first-degree relative with a known diagnosis of blood disease, tumors, or another disease that can be treated with bone marrow transplantation, and that there is a high probability that he will need a bone marrow transplant in the coming years.
Preservation of the meal will be carried out on an ad hoc basis in the public cord blood bank, only in the event that the meal is suitable for the patient for whom it was allotted, as determined by the Ministry of Health, and this is for a period of time up to four years. To do this, you must refer to the attending physician and the HMO.

Cord blood banks for private use (family)

Private (and family) cord blood banks collect, process and store cord blood meals for the condition that a meal will be needed for the newborn (personal use, self) or a close family member (usually a brother/sister of the same parents). These banks also hold umbilical cord blood meals that do not meet the updated requirements for bone marrow transplantation (eg, meals that have a low number of stem cells). These meals are not recorded in national and international databases and are not intended for use by the general patient population. In these meals, it is not required to carry out tissue matching assays.
Cord blood banks also suggest saving meals for future uses that are not intended for the rehabilitation of the hematopoietic system, and which are still unproven or not researched.
Private custody banks generally operate as commercial interests, for profit purposes. These banks charge the parents for the preservation of the newborn’s cord blood, and guarantee that the meal is preserved for the period specified in the contract.
If you decide to keep cord blood in a private cord blood bank, you must make sure in advance that the bank is approved by the Ministry of Health, check the details of the agreement, including the existence of cord blood collection agreements with the hospital where the delivery will take place.
Your rights regarding the preservation of cord blood details:
1.  Umbilical cord blood should be preserved voluntarily by the mother or by decision of the parents and without pressure .
2.  In order to obtain informed consent the mother shall have the right to obtain, from a person authorized to give these explanations, relevant information, in understandable language, as soon as possible, orally and in writing – through an information page and to the extent necessary for the decision-making.
3. The  mother has the right to obtain a copy of the consent form that she signed.
4.  After the meal has been collected and deposited, the parents are entitled to obtain from the private bank a confirmation of the deposit in writing containing information regarding the meal collected and tested, the results of the tests performed for the meal, the number of cells in the meal (along with the few requirements of the bank) and where the meal was kept .
5.  Parents have the right to obtain a copy of each form or agreement they signed before the bank.
6.  If a cord blood meal collected at birth is not suitable for use, the parents have the right to choose whether or not to keep it though.
7. The  cord blood meal that is deposited in the bank for special preservation belongs to the newborn (as cord blood was collected after birth). It is allowed to transfer it for cultivation only according to his instructions – or according to the instructions of his guardian (his parents – until the age of 18 years).
8.  Cord blood meal cannot be reserved or mortgaged.
9.  The Bank and all its employees are obligated to maintain the confidentiality of any information or documents containing personal information about customers and newborns that have reached them in the course of performing their duties and work. Information may be provided only when it is required to carry out provisions of the Cord Blood Act, bank oversight, or upon a court order.
Questions to ask before deciding whether to keep cord blood in a private cord blood bank
 Questions on the subject of permits and agreements affiliated with the private cord blood bank (company):
  • Does the bank have a valid permit from the Ministry of Health?
  • Does the bank have a valid agreement with the hospital where the delivery is planned?
  • In the event that the bank closes or declares bankruptcy – what will happen to the cord blood meals? Does the bank propose a mechanism that will ensure the continuity of keeping meals in the event that the bank stops working for any reason? If yes, what is the mechanism?
  • Does the Bank propose, in addition to conservation, insurance for agriculture as well? If yes, in which insurance company? What are the terms of the policy, who is the beneficiary of the policy and how do we activate it? How is payment guaranteed to the insurance company?
  • How long does the company work in cord blood preservation?
  • Who is the medical director of the cord blood bank?
  • How much cord blood meal is actually kept privately in the bank?
  • Does the bank also have a wing that collects for public preservation?

General questions: 

  • What are the factors that affect the ability to store umbilical cord blood in a private cord blood bank?
  • Until what week of pregnancy can join the service?
  • In premature labour – what is the lowest week of pregnancy it will not be possible to do a meal combination?
  • What are the cases in which it is not possible to collect the meal during childbirth?
  • What are the procedures accompanying the collection of umbilical cord blood?
  • Were blood samples taken from the mother? If yes, by whom and when?What tests are performed with these samples?
  • Will and how will the results of tests conducted in cord blood and in the mother’s blood be delivered?
  • What collection equipment will be provided on occasion/at birth? Do they include special instructions for medical staff?
  • Which endorsement will be given regarding the meal deposit? What information is included in the certification and how will it be passed on to the birth’s parents?
  • What documents are kept in the bank regarding the meal and how can I obtain a copy of it?
  • What are the means taken by the bank to maintain the privacy of customers?
  • Will the bank use the customers’ details for marketing, mail or any other matter not related to the bank’s business?
  • Does the Bank reserve the right to unilaterally change the agreement on the details of any of the details detailed above? How will the bank report the change?
  • In the case of a periodic payment – can the payment change over time or is it fixed?
  • Under what conditions can a partial refund be obtained for a meal that was found to be unsuitable for preservation?
  • Is there a different price for keeping meals for more than one newborn in the same birth or meals for other babies in the future?
Questions related to the handling of the cord blood meal: 
  • How will the meals go from the hospital to the bank after the birth and is the transportation included in the price?
  • Are there special instructions for collection and transportation over the weekend?
  • What happens if a meal is infected in the process of transportation?
  • What is the collection and storage method used in the bank (test bags/tubes)?
  • Do you store the meal as one unit or several individual meals?
  • Where is the meal prep site?
  • If the meals are kept outside Israel – what are the legal requirements for cord blood to be kept in the same country? How is it guaranteed that the meal will be returned to Israel when needed?
  • Are meals kept in a separate freezer or together with biological samples of other species?
  • In which laboratory are the tests performed for the meal and which tests are carried out?
  • What is the minimum number of cells per serving (compared to the accepted standard)? Are there other conditions that will lead the bank to rule that the meals are not fit for preservation?
  • Does the bank agree to keep meals identified as unfit for preservation? If yes, what are the conditions?
  • Are meals found with contamination kept separate from all meals (quarantine)?
  • Does the bank use part of the meal to ensure quality or for other purposes?
  • What is the bank’s policy regarding spoiled meals (eg due to non-payment)?

Cost of keeping in a private cord blood bank

Cost of keeping in a public cord blood bank
A donation of cord blood to a public cord blood bank is not payable, and there is no entitlement to payment or other benefit.
It is important to emphasize that in the process of donating to a public cord blood bank the parents waive any right, ownership or otherwise, including the right to receive information about the fate of the meal.
Cost of keeping in a private cord blood bank 
 
The cost of preserving cord blood in private cord blood banks is several thousand shekels, and it varies between different banks. Some banks allow the choice between periodic payment and prepayment. A section of the HMOs supports the services through supplementary insurance (additional health services). A section of the banks proposes various additions to the conservation deal such as insurance for the cultivation process.
It is important to compare the proposed services, obligations and costs before making any decision.
If parents decide not to save a meal found to be unsuitable – they are entitled to pay only for the collection and the work done to check it. Payment for a meal that is not kept does not exceed 20% of the total pre-set price, or about -2,000 NIS (linked to the cost of living schedule from 2012), whichever is lower and according to the type of transaction. If you have already paid, you will be entitled to a partial refund.

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