Getting in touch. Everything you need to know. (and probably a bit more too!)

Transcription

1 Getting in touch For more information about collecting and storing your child s umbilical cord stem cells, please get in touch with our customer care team who can answer any questions you might have: Telephone: +44 (0) info@biovaultfamily.com For more information about stem cells and their potential uses, please visit our comprehensive website at: Everything you need to know (and probably a bit more too!) Biovault Family Plymouth International Medical and Technology Park, 24 Brest Road, Derriford, Plymouth PL6 5XP Telephone: +44 (0) Fax: +44(0) info@biovaultfamily.com

2 Thank you! We are really pleased that you have chosen to find out more about how we can help you protect your child s future. I would be happy to recommend Biovault, and will use the service again if my daughters and sons provide more babies! The main reason I opted to bank cord blood with Biovault is that my father has Parkinson s Disease. Finding a cure for it is close to my heart really. Hopefully, with tremendous advances in stem cell research, they ll find a cure for it and related diseases. By banking cord blood, I am ensuring that we can potentially benefit in the future. Gina Mellotte James Calvert In this pack you will find: Today and tomorrow - what is happening in cord blood banking Educational information guide - all of your questions answered Cord blood and cord tissue questionnaires and contracts - for you to proceed Useful information on current cord blood issues I became aware of stem cell potential after a scan indicated there could be potential problems. Naturally I was concerned and researched things in detail that is when I found out about the possibilities of cord blood banking. There was potential for one or both of our twins to have eyesight problems. Our research led us to some intelligence in the United States which indicated that banking cord blood could be beneficial just in case it was needed to treat such a problem. We saw it as the ultimate insurance policy. The twins have no brothers or sisters plus my husband and I are older parents. It was a unique chance to bank against potential problems in the future. Naomi Keep

3 Sky Sport s F1 Presenter Natalie Pinkham When you step back and take a look at your child s future, our decision was about securing the ability in the future to benefit from the huge potential stem cells have to protect, not just this baby, but also future siblings and even ourselves. From having my questions answered by qualified experts, through to putting in place the necessary arrangements for collection, I ve been impressed with Biovault Family. Like you and Natalie, all of the expectant parents we ve helped had numerous questions about cord blood banking. whilst pretty common in the United States and mainland Europe, it s still new here in the uk. So naturally, there is plenty of reassurance needed. As the most highly accredited Private Human Tissue Bank in the country, we wanted to bring everything together to provide you with the most comprehensive information on cord blood and cord tissue banking. Please sit back, make yourself comfortable and find out everything you need to know. Remember our team of experts are on hand for a chat if you have any questions. 1

4 Looking after tomorrow - today Five years ago, the chance of a child needing stem cells throughout their lifetime to treat a medical condition was around 1 in 4,000. Today, with the huge advances in stem cell therapy, this has risen to 1 in 450 and this figure only takes into account the current therapies that actually use stem cells. With research continuing into a wide range of medical conditions, the chances of a child needing their umbilical cord stem cells will only increase. Everyday, science pushes back the boundaries of what we know about how our bodies work and how diseases and disabilities affect us. Every day, real scientific advances and medical discoveries offer new scope to improve the quality of our lives and the lives of our children. Today, cord blood is currently being used to treat: Leukaemia Anaemia Neuroblastoma Retinoblastoma Sickle Cell Disease Thalassemia Cerebral Palsy Diabetes Today, the following research is taking place using cord blood stem cells: Autism Crohn s Disease Multiple Sclerosis Spinal Cord Injury Biovault has processed, stored and released the following samples for treatment: TRANSPLANT CENTRE USED TO TREAT Haematology and Stem Cell Transplantation Centre, Mount Elizabeth Hospital, Singapore Stem Cells and Immunology Department, National Blood Service, Birmingham, UK Kinderklinik der TU Munchen, Munchen, Germany Gaslini Institute, Largo Gaslini, Italy Duke University Medical Center North Carolina, USA Duke University Medical Center North Carolina, USA Imperial College Healthcare NHS Trust, London, UK Royal Marsden NHS Foundation Trust, Surrey, UK Duke University Medical Center North Carolina, USA Hospital Infantil Universitari Servicio de Transfusión, Madrid, Spain Thalassemia Allogeneic transplant Thalassemia Neuroblastoma Cerebral palsy Cerebral palsy Sickle cell disease Acute Lymphoblastic Leukaemia Cerebral palsy Cerebral palsy 2

5 From scan-photo to storage certificate Pregnant Questions Cord Blood Congratulations! No doubt you ll be overwhelmed with advice and tips... Naturally, you ll start turning your attention to protecting your child s future. With so much to consider, from names to what type of birth you d like to nursery decoration, you ll have a big list of questions to answer. Our tip is to write them down in one master list! Relatively speaking cord blood and tissue banking is new so it might not be possible to seek recommendations from friends and family. That said, it is a rapidly growing area for expectant parents wanting to protect their family s future. Purchase Contact an expert Info gathering We offer a range of finance and storage duration options for you to select from. In addition, we were the first UK cord blood bank to offer an Escrow guarantee so your money is completely safe with us. Our expert team is on hand to answer any questions you might have. Our policy is to inform you of all available information and not speculate in any way, so that you can make a clear and confident decision. It is a competitive market with lots of jargon. Rightly, it is a heavily regulated market, so take your time to assess reports from independent organisations like the HTA (Human Tissue Authority). Maternity ward Sample taken Safely shipped Make sure you pack the collection kit with your hospital bag ready for the big day! Once the midwife has checked that you and your baby are OK, the cord blood and cord tissue can be collected by the healthcare professional using our stem cell collection kit. A sample of your blood (the maternal blood sample) is also required and can be collected before or after your baby has been born. We need to check for certain infectious diseases, this is a requirement in the UK. Simply get your birthing partner to call us & we will arrange for a specialist courier to collect the stem cell collection kit from you. The courier will deliver the kit to our laboratories ready for processing and storage. Storage certificate Stored at -180C Processed - lab Once all testing is completed, we will take the second and final payment for processing and storage. We will then send you your baby s storage certificate! The umbilical cord blood and tissue samples are transferred to barcode labelled storage bags in canisters that are also barcode labelled with tamper-evident seals. The samples are then frozen in a controlled manner to prevent ice crystals forming in the bag. Once frozen the samples are stored in vapour phase liquid nitrogen. 3 Your samples are transferred into a sterile environment for processing. The cord blood and tissue samples are tested, processed and prepared for freezing. We also assess the number of cord blood stem cells (CD34+) and their viability for future use.

6 Why choose Biovault Family? The most secure We were the first private UK cord blood bank to offer a storage guarantee. This means the storage money you pay us is secured in an independent Escrow account for the full 25-year term. Each January a proportional amount is released to pay for the upcoming year s storage. It can t be used to fund our business or for any other purpose. The most experienced Biovault has released over 4000 stem cell samples for transplantation more than any other private cord blood and tissue bank in the UK. The most accredited We are the most highly accredited private cord blood and human tissue bank in the UK and the only one to have JACIE accreditation Europe s highest standard. Licenced by the HTA, we re also accredited by major standards such as UK NEQAS and ISO. The most trusted We were the first UK private cord blood bank to be trusted and used by the NHS a relationship that is still growing as a result of our established partnership. The most expertise Biovault Family is part of the Biovault Group which includes Biovault Technical a world leader in tissue banking. The single largest shareholder of the Biovault Group is Plymouth University. Selected across the world As well as providing stem cell and umbilical cord blood storage for customers across the United Kingdom we are also the chosen processing and storage centre for other companies across Europe and the Middle East. 4

7 Educational Information Y o u r questions answered: What is Cord Blood? What can it be used for? What are the options available to me? Why should I consider saving my baby s umbilical cord blood? Why should I consider saving my baby s cord tissue? Consent How are the cord blood and cord tissue collected at birth? How does the process work if I use your services to privately store my baby s stem cells? What happens once my sample is procured? How is the cord blood processed? What tests will be performed on my blood? What tests will be performed on the cord blood and tissue? What if I require my child s sample for a treatment, what do I do? References Biovault is Europe s best cord blood bank Carlos Moreno, Biocord, Madrid 5

8 The information in this document is to ensure that you are aware of your options with regards to saving your baby s cord blood at the time of birth. It also details the tests that will be carried out should you decide that you want to save your baby s cord stem cells. If after reading this document you have some questions please do not hesitate to contact us. 1. What is Cord Blood? Cord blood is the blood that remains in the placenta and umbilical cord following the birth of your baby. After your baby is born the placenta (and all the cord blood in it) is normally thrown away. Cord blood contains stem cells that may be cryopreserved for later use in medical therapies, such as stem cell transplants or clinical trials of new stem cell therapies. 2. What can it be used for? There are standard therapies which cord blood can be used for. These are diseases for which transplants of blood-forming stem cells (Hematopoietic Stem Cell Transplants, HSCT) are a standard treatment. For some diseases they are the only therapy and in other diseases they are only employed when front-line therapies have failed or the disease is very aggressive 1. Cord blood stem cells are used as an alternative to peripheral blood and bone marrow stem cells and have been used in the treatment of a range of diseases including leukaemia, immunodeficiency, sickle cell anaemia, lymphomas and other diseases of the blood. For some conditions there may be a genetic predisposition to that disease, and therefore the child may not be able to use his or her own stem cells. In these cases a matched sibling s stem cells would be the first choice before looking for alternative donors. 3. What are the options available to me? There are 3 options available to you at the time of birth. Donate your umbilical cord to a public bank (if you are giving birth in one of the hospitals where public bank samples are collected). Store the umbilical cord privately for that child or another member of the family Discard the umbilical cord at the time of birth and not store it. (a) Public Donation Public banks are publicly or government funded facilities that collect cord blood from public hospitals, free of charge to the donor. The cord blood unit is then stored indefinitely for possible transplant. The unit is tissue typed by the public bank and then the details recorded on a register that can be accessed by clinician s searching for a suitably matched unit for a patient on the Bone Marrow Donor World Wide database. This unit is available for any patient in the world that needs this particular special tissue type. There is no charge to the donor but the product is not stored specifically for that person or their family. In the UK The Anthony Nolan Trust and the NHS Cord Blood Bank are examples of public banks that are NETCORD registered and this means the cord blood units are registered on databases that can be accessed all over the world. The donation is free and once you have donated your cord blood it is then available to be used by unrelated patients who require a transplant or by scientists for research. (b) Private Banking Private banks, on the other hand, allow the donors to store their cord blood (upon paying a registration fee and then a fee for processing and storage of the cord stem cells) in case a family member becomes sick with a stem cell treatable disease in the future. It is important to point out though, that the chances of ever needing a cord blood transplant are very slim. However as research into regenerative medicine develops the chances of using the stem cells increases. Over 10 years ago the chances of using your own stem cells was quoted to be in the region of 1: A paper in 2008 looked at the lifetime probability of a person in the USA using their own stem cells and stated it to be about 1:400 if the indication for autologous uses does not change much during the next 70 years 2. (c) Discard the umbilical cord The umbilical cord tissue will be discarded with the placenta and disposed of by the hospital as clinical waste. 4. Why should I consider saving my baby s umbilical cord blood? The blood in the umbilical cord and placenta contains stem cells that could potentially be used for the treatment of that child or another member of the family. Umbilical cord blood is rich in hematopoietic stem cells cells that can renew or differentiate. These stem cells form the building blocks of the blood and immune system. Research is continuing into the possibilities of treating diseases such as breast cancer, HIV, diabetes, and disorders of the nervous system such as Parkinson s disease and Alzheimer s. The main 6

9 advantage of using cord blood over bone marrow is that the stem cells if stored are readily available whereas it may take a long time to find a suitable peripheral blood stem cell or bone marrow donor. Also, bone marrow donation can be an invasive and painful process. As the cord blood and stem cells stored belong to the donor child, the risk of rejection is eliminated and there is a greater chance of the stem cells being suitable for other members of your family should the need arise. Cord blood stem cells are used as an alternative to peripheral blood and bone marrow stem cells and have been used in the treatment of a range of diseases including leukaemia, immunodeficiency, sickle cell anaemia, lymphomas and other diseases of the blood. For some conditions there may be a genetic predisposition to that disease, and therefore the child may not be able to use his or her own stem cells. In these cases a matched sibling s stem cells would be the first choice before looking for alternative donors. 5. Why should I consider saving my baby s cord tissue? The cord tissue, or Wharton s Jelly as it is sometimes referred to, is a rich source of mesenchymal stromal stem cells. Mesenchymal stromal stem cells have shown that they have the capability of regenerating damaged or diseased tissues and can differentiate into a range of tissues including bone, nerve, tendon and muscle. It is hoped that in the future they will play an important part in a variety of medical and clinical procedures. There is extensive research on-going into the clinical uses of these stem cells. However, it must be stressed that these trials are in their infancy and thus, the use for this tissue is currently not proven. However, due to the potential use of these cells many of our customers have already taken the option to store their child s cord tissue. The cord tissue is prepared and processed for long term storage, so in the future when the technology is available, the Mesenchymal stem cells could be isolated if required. 7

10 6. Consent Prior to the delivery of the kit, you will be required to complete a consent form which details the collection, processing and storage of your baby s cord blood stem cells. This information should assist you in making your decision for storing or discarding your cord blood and tissue at the time of birth. If you choose to store with Biovault Family, in addition to the consent form, we will need to speak with you to take informed consent to ensure you understand the following; 1. The service that you are signing up for 2. The uses of cord stem cells 3. The collection procedure - it may not be possible to perform a collection and it is up to the clinician to decide if it is safe to collect the cord stem cells. The wellbeing of you and your baby are the number 1 priority. 4. The tests that we will perform on your blood sample 5. Your right to withdraw consent - Consent can be withdrawn at any point of the collection procedure, processing and storage of your child s stem cells. 6. Ownership of the cord stem cells. You as the mother are the legal guardian of the cord stem cells until your child, turns 18 years old. At this point the ownership of the cells transfers to the child. 7. Right to ask questions and have answers you will have the opportunity to ask any questions that have not been answered at this point. 7. How are the cord blood and cord tissue collected at birth? Collection of the cord blood In the UK, the collection is always made after the baby is born, once the cord is cut and after the placenta has been delivered. The collection of cord blood is completely safe for both mother and baby. The collection of the cord blood requires the cord to be clamped and cut in the normal way. The cord and placenta are then removed to enable the collection to take place. The cord blood is drained from the cord as soon as possible after it has been clamped and cut. It is widely reported that delayed clamping of a few minutes is beneficial to the baby. Whilst it is still possible to collect the cord blood after delaying clamping for a short period, after extended periods less blood will be collected or the cord blood may have started to clot. The more blood collected, the more stem cells there are in the sample. If you wanted to have an extended delayed clamping once your baby has been born we would not recommend that you use our services. Usually at the time of birth, you will have to give blood samples as the mother, to perform some tests that are a mandatory requirement in the UK (see section below). This is to check for any viral infections that may require your baby s sample to be stored separately. Having an infection does not prevent your sample from being stored. 8. How does the process work if I use your services to privately store my baby s stem cells? If you wish to use our services, we will send you an application pack for you to complete. There will be a maternal health questionnaire for you to complete and a consent form to sign. The purpose of the maternal health questionnaire is to see if you are at risk from carrying any of the viruses that we will screen for or any other diseases that we need to know about, as there are some diseases that mean that the stem cells should not be used. We will use the maternal health questionnaire alongside the test results to assess any risk there may be to your sample. Once we have received the documents back we will call you to perform an informed consent check to ensure you understand the service you want and the steps that you need to take on the day your baby is born. If your midwife or doctor is unable to collect the cord blood at the time of birth you will need a phlebotomist to collect it for you. If you require a phlebotomist to collect the blood for you, we will arrange this for you. Once we have taken the informed consent and the kit deposit we will send out a collection kit to you ready for your big day. If you are having a phlebotomist to collect your baby s cord blood then you will need to call them when you go into labour. They will then keep in touch with you to ensure they are there in good time to collect the cord stem cells. Once your baby has been born and the midwife or doctor has decided it is safe for the collection to take place they or the phlebotomist will perform the collection. They will also have to take a sample of your blood for some tests (see below). 9. What happens once my sample is procured? Once the sample(s) are procured, they are packed ready for collection, your birthing partner simply calls our on call line and we will arrange for them to be collected. 10. How is the cord blood processed? There are 2 different methods. (1.) Whole blood storage This is where the cord blood is frozen without removing any red blood cells or plasma. The red blood cells have been associated with harmful or fatal side effects if too many of them are used in a transplant 3,4,5. If a cord blood sample is stored whole without removing the red blood cells the sample will have to be washed before it can be transplanted. (2.) Volume Reduction This is the processing of the cord blood to remove the red blood cells. The red blood cells are removed because freezing them renders them potentially toxic as they lyse. Plasma is also removed because it doesn t contain any stem cells and if any were required it can be very easily sourced from a blood sample. By isolating the stem cells by the volume reduction method, the sample is treatment ready when frozen and is the most widely employed method. Biovault Family use the 8

11 volume reduction method to ensure your product is treatment ready. 11. What tests will be performed on my blood? If human tissue or cells are being stored in the UK then it is a requirement that the donor (in this case the mother) is tested for some viral infections which are listed below with an explanation about the virus and the implication of a positive test result. We will perform the following tests on your sample. HIV HIV stands for human immunodeficiency virus. The virus attacks the immune system, and weakens the ability to fight infections and disease. HIV is most commonly passed on through unprotected sex. It can also be transmitted by coming into contact with infected blood for example, sharing needles to inject steroids or drugs. There s no cure for HIV, but there are treatments that allow most people to live a long and otherwise healthy life. We test for HIV in 2 ways; by looking for antibodies/antigens to the virus, and also by Nucleic Acid Testing (NAT) looking for the virus DNA. Between the 2 methods we can confidently say if there is evidence of any recent or ongoing HIV infection, even the early stages of infection. If the test finds no signs of infection, then your test result is negative. If the HIV virus has been found in your blood then the test result is positive. HTLV Human T-cell lymphotropic virus (HTLV) is a rare but potentially serious virus, which in some people can cause a type of leukaemia that can be fatal. HTLV-I and HTLV-II can be transmitted sexually, by blood to blood contact (e.g. by blood transfusion or sharing needles when using drugs) and via breast feeding. Hepatitis B Hepatitis B is a type of virus that can infect the liver. We will test your blood to see if you have a new infection, chronic infection, have recovered from an infection or have been vaccinated from the infection. Hepatitis B can be spread through blood and body fluids. Hepatitis B in pregnancy A mother can also pass on the hepatitis B infection to her new born baby, but the infection can be prevented if the baby is vaccinated immediately after birth. Hepatitis B is tested in a number of ways. Before explaining the tests, there are two basic medical terms that you should be familiar with: Antigen: A foreign substance in the body, such as the hepatitis B virus. Antibody: A protein that your immune system makes in response to a 9 foreign substance. Antibodies can be produced in response to a vaccine or to a natural infection. Antibodies usually protect you against future infections. One of the tests used to help you understand your hepatitis B status is called the hepatitis B blood panel. This is a simple 2-part blood test that we perform on your blood sample. The 2-part hepatitis B blood panel includes the following: 1. Hepatitis B Surface Antigen (HBsAg): The surface antigen is part of the hepatitis B virus that is found in the blood of someone who is infected. If this test is positive, then the hepatitis B virus is present. 2. Hepatitis B Core Antibody (HBcAb or anti-hbc): This antibody does not provide any protection or immunity against the hepatitis B virus. A positive test indicates that a person may have been exposed to the hepatitis B virus. Both separate test results are needed to make a diagnosis. Quantitative Hepatitis B In addition Hepatitis B is tested for using a quantitative test conducted to detect the viral load of Hepatitis B, this is done by means of a Nucleic Acid Testing (NAT) technique. Viral DNA is often detectable sooner than antibodies, therefore the NAT test will show evidence of recent exposure and how much of the virus is present. Hepatitis C Hepatitis C is a virus that infects the liver. If left untreated, it can cause serious and potentially life-threatening damage to the liver over many years. However, with modern treatments it s often possible to cure the infection and most people with it will have a normal life expectancy. It s estimated that around 215,000 people in the UK have hepatitis C. You can become infected if you come into contact with the blood of an infected person. The hepatitis C virus is usually spread by blood-to-blood contact. The antibody blood test determines whether you have ever been exposed to the hepatitis C virus by testing for the presence of antibodies to the virus. Antibodies are produced by your immune system to fight infection. The test will not show a positive reaction for some months after infection because your body takes time to make these antibodies. If the test is negative, but you have symptoms or you may have been exposed to hepatitis C, you may be advised to have the test again. A positive test indicates that you have been infected at some stage. It doesn t necessarily mean you are currently infected, as you may have since cleared the virus from your body. In addition to this a further quantitative test is conducted by NAT technique. This shows the quantitative viral load and will identify a current infection before an antibody based test will.

12 Syphilis Syphilis is a bacterial infection that in the early stages causes a painless, but highly infectious sore on your genitals or around the mouth. The sore can last up to six weeks before disappearing. A simple blood test can usually be used to diagnose syphilis at any stage. The condition can be treated with antibiotics, usually penicillin injections. Cytomegalovirus (CMV) You will also be tested for Cytomegalovirus (CMV), this is a common virus that belongs to the herpes family of viruses. It s spread through bodily fluids, such as saliva and urine, and can be passed on through close contact with young children. Most cases of CMV don t cause symptoms. If you do have symptoms, they re often similar to flu or glandular fever, and include a high temperature (fever), sore throat and swollen glands. When you develop a CMV infection for the first time, it s known as primary CMV. It s thought that 50-80% of adults in the UK have a primary CMV infection. Once you ve been infected, the CMV virus stays in your body for the rest of your life, but in most cases it remains inactive and doesn t cause further problems. However, CMV can sometimes be reactivated (recur). This usually only occurs in people who have a weakened immune system for example, due to untreated HIV or taking immunosuppressant medication to prevent transplanted organs being rejected. It s also possible to become infected again with a different strain of the CMV virus. This is known as reinfection and usually causes similar symptoms to a primary infection. Active CMV is a term that describes someone who s infectious to another person and can be due to primary infection, reinfection or reactivation. Active CMV in someone with a weakened immune system is usually treated with antiviral medicines, which slow the spread of the virus. Some cases may need to be treated in hospital. Babies with congenital CMV may also need antiviral treatment. What happens if there is a positive result found? We will send you a copy of all of your test results from the blood tests that we have carried out on your blood sample. If a positive a result is found we recommend that you make an appointment to discuss the result with your GP as soon as possible. 12. What tests will be performed on the cord blood and tissue? After processing the cord blood and if applicable, cord tissue we will perform some tests to see if the sample is suitable for storage. We will test the cord blood sample to determine the following; (a) The number of total nucleated cells (TNCs), This is the total number of nucleated cells in the cord blood. It does not indicate how many stem cells there are in the cord blood. (b) The number of stem cells (CD 34+ cells) This is the number of stem cells in the cord blood unit and is measured by counting the number of cells that express the CD34 molecule. Hence stem cells are often referred to as CD34 positive cells (c) The viability of the CD 34+ cells This is an assessment of how many of the stem cells are alive. Congenital CMV If a pregnant woman has an active CMV infection, the virus can be passed to her unborn baby. When it affects a baby in the womb, it s known as congenital CMV. In the UK, it s estimated that one to two babies in every 200 will be born with congenital CMV. Of these, about 13% will have problems at birth, such as hearing loss and learning difficulties, with a similar number developing problems later on. Treating a CMV infection CMV isn t usually diagnosed because it doesn t cause symptoms for most people. If you re at risk of developing complications, a blood test can help determine whether you ve ever had CMV or if you ve recently caught it for the first time. Urine and saliva swab tests can be used to find out whether a new-born baby has congenital CMV. Most CMV infections are mild, don t cause symptoms and don t need to be treated. If you do have symptoms, painkillers can be used to help reduce any pain or fever. 10

13 (d) The total nucleated red cell count This is a count of the number of red blood cells containing a nucleus (these are found in the blood of infants). If the cord blood unit fails to meet our acceptance criteria then we will call you to discuss your options. You can either choose to dispose of the sample and there will be no further charges to pay or you can continue to store. If you continue to store the processing and storage fees will be payable and we will require you complete a consent form to state that you have been informed that the sample has not met our acceptance criteria but you wish to continue to store the sample. The table below is taken from the HTA website. It has been developed by the HTA, stem cell experts, including UK transplant centres, to help you make the decisions about private cord blood banking and is not meant to be a guide for clinical decision making. MEASUREMENT INCREASING NUMBER OF CELLS TNC count (The number of cells in a cord blood unit before freezing Fewer than 500 million (<5 x 10 8 ) A More than 500 million (>5 x 10 8 ) More than 1250 million (>1.25 x 10 9 ) CD34 + count (Total number of stem cells in a cord blood unit before freezing) Fewer than 4 million (<4 x 10 6 ) More than 4 million (>4 x 10 6 ) More than 10 million (>1 x 10 7 ) Potential use for the cord blood May be unsuitable for transplant C but may be stored for potential use in clinical trials or future therapies May be suitable for child D stem cell tranplant May be suitable for adult E stem cell transplant Table: How could privately banked cord blood be used? This table has been developed by the HTA with stem cell experts to give you an idea of how measurements like the number of TNCs and CD34+ cells in your cord blood can determine how privately banked cord blood could be used. We hope that this will help you to interpret information that may be provided to you by private stem cell banks about your cord blood. A 5 x 10 8 is another way to write 500 million. You may see numbers written this way on reports from the private cord blood bank. B Stem cells used for established treatments discussed in this section are prescribed according to the weight of the recipient patient. C Transplant refers to transplantation for current established treatments as described in this guidance. D Based on a recipient weight of greater than 20 Kg. For children weighing less than 20kg, appropriate cell numbers may be estimated based on weight using >2.5 x 10 7 TNC / kg and >2 x 10 5 CD34+ cells / kg. E Based on a recipient weight of greater than 50 Kg. For adults weighing less than 50kg, appropriate cell numbers may be estimated based on weight using >2.5 x 10 7 TNC / kg and >2 x 10 5 CD34+ cells / kg. 11

14 (e) Sterility Testing Both the cord blood and if applicable, cord tissue sample will have a sterility test performed on them to check if the samples are contaminated with any microorganisms e.g. sometimes samples can be contaminated with bacteria (microbial contamination) due to the nature of birth. We will send you the results and if there is any contamination we will also send you the antibiotic sensitivity. We will require you to complete a form to state that you have been informed that the sample is contaminated. If your sample does have some microbial contamination in it, it can still be stored and it is not a reason not to store, however there may be clinical implications of contamination at the point the sample is ever used. The storage fees will still be payable for the cord tissue unless we inform you that we do not advise you to store. In addition the product will be tested for (f) ABO Blood type and Rhesus status of the cord blood Human Leukocyte Antigen and Haemoglobinopathy testing in separate cases where an allogeneic transplant is required. To determine the suitability and compatibility of the product with the donor. References 1. Parents Guide Cord Blood Foundation website 2. Lifetime Probabilities of Hematopoietic Stem Cell Transplantation in the U.S, J.J. Nietfeld et al March 2008, Volume 14, Issue 3, Pages HTA Website Cord blood Banking Guide ( 4. Why red blood cells should be removed before cord blood storage. Andromachi Scaradavou, MD, Medical Director of the New York Blood Center s National Cord Blood Program. Published on Parents Guide to Cord Blood Foundation website. 5. Just the Facts Letter FACT Spring NHS Choices website ( Introduction.aspx) 13. If I require my child s sample for a treatment, what do I do? If you require the sample for use with your child or a family member contact us as soon as possible. We will need to be informed of your consultant who is going to be performing the transplant and we will need permission to contact them to discuss your sample. We will then send to them the full set of records for that sample and perform any additional tests depending on the treatment they require on sub samples that we have stored for that sample. We will then at the request of the consultant release and send the sample to them. This can be anywhere in the world. We will send it free of charge if being released for that child or a sibling. 12