Securing the future of your family s health

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2 Biovault Family offers parents the chance to save their baby s cord blood at the time of birth. Cord blood is the blood that is contained within the placenta and the umbilical cord. The umbilical cord, as you know, connects the baby inside the womb to the mother s placenta. Through the cord the baby receives all the nutrients and oxygenated blood it requires during its development. As the building blocks of our bodies, stem cells play a vital role in keeping us healthy and disease-free. When a baby is born there is a unique opportunity to collect the baby s umbilical cord blood that contains an extremely rich source of stem cells. The cord blood is normally discarded as clinical waste but an increasing number of parents are opting to collect and store their child s cord blood stem cells at birth. In recent years, the number of conditions that stem cells can treat has vastly increased; who knows what the future holds? 2 Welcome to The cord is also used to take away from the baby all the waste products such as carbon dioxide and deoxygenated blood back to the mother via the placenta. Once the baby has been born the cord is cut from the baby. The cord and placenta both still have blood within them that contains stem cells. These stem cells are fully developed and, in biological terms are described as adult stem cells. So what are stem cells? Stem cells are a class of undifferentiated (that is they are not biologically committed to become particular tissue), cells that are consequently able to differentiate into specialized cell types. Commonly, stem cells come from two main sources, the embryo (embryonic stem cells) and fully developed or adult tissue (adult stem cells). Cord blood contains adult stem cells. The stem cells in the cord blood are the building blocks of the blood and immune system. Every day, science pushes back the boundaries of what we know about how our bodies work and how diseases affect us. Every day, real scientifi c advances and medical discoveries hit the headlines, offering new scope to improve the quality of our lives. Biovault the UK s leading tissue bank Biovault has unparalleled expertise do store cord blood samples for in the collection, processing families in the UK, across Europe and storage of stem cells from and further afield and most umbilical cord blood, preserving importantly in a highly ethical way. their potential for the future. As Our cutting-edge UK facilities a full service tissue bank storing and industry-leading processes many types of human tissue mean that Biovault has the highest for transplant, Biovault is fully recorded rate of stem cell recovery accredited by the UK s Human in the industry, exceeding 95%. Tissue Authority. We can and This publication aims to provide clear, accurate and factual science-based information on umbilical cord blood collection, processing and storage to help families make an informed decision as to whether it is right for them. This document is provided to a wide range of interested individuals so should you have any questions about stem cells and their potential, our comprehensive website has much more information United Kingdom: Hong Kong: and our team of experts are standing by to help United Kingdom: +44 (0)

3 Why store umbilical cord blood? The birth of a child is an exciting, life-changing event for parents. It is also an event that presents a unique opportunity to help safeguard the child s health in the future. 4 Adult (fully developed) haematopoietic (blood) stem cells found in low concentrations in blood and high concentrations in bone marrow have been used for years to treat diseases such as leukaemia, sickle cell anaemia, and other disorders of the blood. These cells are capable of producing all blood cell types, such as red blood cells that carry oxygen and white blood cells that fi ght disease. Although possible, diffi culties arise in the extraction of these cells through the use of invasive bone marrow harvests particularly in patients that are already ill. Stem cells in the normal blood fl owing around the body occur in too low a concentration without diffi cult medical procedures, but a wide cross-section of stem cells including haematopoietic stem cells are found in the umbilical cord and placenta in high concentrations. Although this cord blood can be preserved it is normally discarded as waste. As stated, the blood that remains in the placenta and umbilical cord after birth is very rich in valuable stem cells. If collected and stored correctly these stem cells could possibly be used in the future to treat that child or, if the match is correct, a sibling as there is a 1 in 4 chance of a match between biological brothers and/or sisters. As an example, if a child was unfortunate enough to develop cancer of the blood the umbilical cord blood stem cells of that child would probably not be used to treat that child as there is a genetic disposition to that disease present in the stem cells. However, if a sibling s cord blood was a suitable match a stored sample could be used to treat the sick child. There are a large number of clinical trials and research being performed looking into the potential use of stem cells to treat many different diseases. Clinical trials are being undertaken that look into the use of stem cells to treat autoimmune diseases (such as diabetes, Crohn s disease, rheumatoid arthritis, lupus), cardiovascular diseases (such as heart attacks, strokes, cardiovascular repair), neurological diseases (such as spinal cord injury, cerebral palsy, Alzheimer s disease). Some of the clinical trials are looking at the use of autologous (using one s own) stem cells to treat the disorders while other trials are looking at using allogeneic (using another person s) stem cells. The number of medical applications for stem cells is rising fast as research continues apace. Five years ago, the chance of a child needing stem cells throughout their lifetime to treat a medical condition was around 1 in 4000 but today, with the huge advances in stem cell therapy, this has risen to 1 in 450, this figure only takes into account the current therapies actually undertaken using 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. The process of collecting umbilical cord blood poses no risk to mother or child yet the potential future benefits are extensive. Stem cells collected from umbilical cord blood at birth are an exact genetic match for that child; however, not only does this mean that the stored stem cells can be used to treat the individual without worry of rejection, there is also that 1 in 4 chance that they will be a match for a sibling. Although the concept of tissue banking is simple prepare, freeze and store the processes behind it are complex. This is why Biovault has developed a pioneering approach; our processes have received widespread acclaim, being described as the gold standard in the industry. Since its creation in 2002, Biovault has established a strong expertise in the recovery of stem cells from an umbilical cord blood sample and currently has the highest published rates of stem cell recovery of any tissue bank in the UK. 5 Read more about Biovault s pioneering approach to processing and the ethical storing of umbilical cord blood and stem cells over the page.

4 Biovault specialises in the storage of human tissue and cells for transplantation. It is the largest private tissue bank and the only one that provides a full tissue banking service to the NHS. Parents rightly expect the best when it comes to their child s cord blood sample. Biovault is a leading tissue bank in the UK, setting the industry standard with its rigorous, ethical approach and high-quality processes. At our cutting-edge facilities Biovault has the capacity to store over one million human tissue samples in a tightly controlled, safe and secure environment. The Human Tissue Authority has Why At Biovault, we are proud of our highly ethical business practices which ensure the safety and security of our clients samples, both now and in the future. While many private tissue banks use pre-paid storage fees paid by customers for the future storage of samples to fund their day-today business, Biovault follows a more ethical approach; we arrange that all funds are held in escrow. In simple terms this is a separate, independent, protected account which is only authorised to release funds for one specific purpose. Biovault? 6 granted us an unrestricted licence that allows us to process and store all transplantable material for human application, one of only a handful of tissue banks with this breadth of capability. Biovault has nearly a decade of experience as a clinical tissue bank, processing and storing both human tissue and cells for use in a wide range of medical and surgical applications. We are the tissue bank for the NHS South-West Peninsula Transplantation Service and we have unrivalled facilities for the processing and storage of umbilical cord blood. In addition to our expertise in the fi eld of stem cell recovery and storage Biovault also works closely with public and private clinics and hospitals to store and supply a wide range of tissues for medical applications. Biovault has built an unmatched expertise in the processing and storage of stem cells for clinical use, and our unrivalled and unique techniques mean that we have the highest published rates of stem cell recovery from umbilical cord blood of any tissue bank in the UK, exceeding 95 percent. As just a part of all the tissue samples stored at Biovault it s cord blood inventory is over 22,000 collections from more than 10 countries. Biovault has released 6 cord blood stem cell transplants on behalf of private clients, 2,500 bone marrow stem cell transplants to private clinics for patients that did not have an option to store and use umbilical cord blood and 320 stem cell transplants sourced from mobilized peripheral blood on behalf of the NHS cancer treatment programme. All the tissue provided for transplant has resulted in 100% engraftment success as of January 2012 meaning that the stored samples have successfully been transplanted in all cases which is the ultimate measure of tissue banking. Biovault does not only provide just-in-case tissue banking; it is improving quality of life for a large number of people on a regular basis right now. Biovault s industry-leading laboratory facilities provide clients with detailed reports on the quality of their sample. Our highly trained technicians build a comprehensive picture of the condition of the sample through extensive testing, ascertaining the number of stem cells present in a sample and their suitability for storage and later use in treatment. We also source full microbiology/virology testing from internationally recognised and fully accredited laboratories. This allows Biovault to draw down only one year s portion of future storage charges, thereby ensuring sufficient funds are always available to cover the full-term storage of clients samples, safeguarding against economic instability. Quite simply, Biovault is at the cutting edge. We have unmatched breadth of capability in processing and storing human tissue, including stem cells and cord blood, for a wide range of clinical applications. If you choose to store your child s cord blood with Biovault it will be in the safest possible hands. 7

5 Biovault Family how our service works Getting started Collecting your Testing your Storing your 8 Our customer care team are standing by to answer any and all questions you might have about collecting and storing your child s umbilical cord blood. If you decide that you would like to go ahead with the collection all you initially need to do is call us. We will then send you our information pack. This will include the consent form (to give written permission for us to collect, process and store your child s cord blood on your, and their, behalf), our health questionnaire (to allow us to handle the blood in the appropriate manner) and your contract. You will need to read and, once entirely happy, sign all documents then return one copy of each to us. You will need to check with your doctor or midwife who will be delivering your baby if they will collect the cord blood for you. If they will not perform the collection, simply call us and we will put you in contact with a healthcare professional who can collect the blood for you. Once we have received all the signed documents and the health questionnaire has been reviewed by our company doctor, we will send you your Biovault Family cord blood collection kit 6 weeks before you are due to give birth. You will need to keep this with the bag that you will take with you to the hospital when you are in labour. Once your baby has been born the cord blood can be taken from the placenta and umbilical cord. This is only done after the cord has been clamped and cut and the midwife is assured that mother and baby are well; these two individuals are the number one priority and in some exceptional cases it may not be possible to collect the cord blood. The collection can take place either while the placenta is still within the womb (in-utero) or after the placenta has been expelled (ex-utero). In addition, your selected healthcare professional will also take a small sample of the mother s blood that must be tested for viral infections that could affect the cord blood sample. The results of this testing allow us to deal with the long-term storage of the cord blood and to inform the clinician should the cord blood be used in a treatment. Biovault provides its clients with a CE Marked Umbilical Cord Collection Kit that contains everything your healthcare professional needs to collect the cord blood sample. Once the cord blood and maternal sample have been taken the documentation is completed, the samples are hermetically sealed for transport and the kit returned to you, the parents. You will then need to call our customer care line to arrange for collection and dispatch to Biovault. This needs to be done quickly as the shortest possible transit time is best for the cord blood and it is also important that the samples are kept at room temperature at all times. Our Collection Kits have been specially designed and manufactured by us to protect and preserve the sample during transport. The umbilical cord blood sample is transported by courier to Biovault s cutting-edge UK facilities. Although cells are still viable 72 hours after collection a sample should arrive at our laboratory after no more than 48 hours. Once the cord blood sample arrives, the kit is unpacked and the sample assigned a unique barcode, it is then prepared for transfer into a sterile environment for processing. Our technical website will provide you with some idea of the processing and facilities at Biovault. The cord blood is tested to ensure it has not been contaminated and also to assess the number of stem cells present prior to processing. Biovault, in common with all public cord blood banks and the majority of private cord blood banks, processes the cord blood to reduce the volume for storage. This process simply removes the unwanted fractions of the whole cord blood, these portions being of no use, or potentially detrimental, in the transplant scenario. The cord blood unit, once thawed, is ready for immediate transplant. A tiny sub-sample is taken to assess the total number of nucleated cells (which includes a wide population of adult stem cells), the number of CD34+ cells (a particularly valuable, undifferentiated type of stem cell) and also the viability of these cells (essentially a measure of the condition the cells are in at the time of processing). We will provide you with a full report once your baby s cord blood sample has been successfully processed and stored and we have all the test results. During processing cells such as red blood cells are removed while the important white blood cells, which includes the stem cells, are retained. Biovault s industry-leading techniques ensure that the loss of valuable transplant material is minimal. At this point the sample is prepared for freezing. During processing, a cryoprotectant (which prevents damage to the sample as it is frozen) is added to the sample which is then transferred under aseptic (essentially sterile) conditions to a barcode labelled storage bag and prepared for freezing. A small sample of the waste products from the processing of the cord blood are stored alongside the main sample as these can be used to test the sample prior to its transplantation. The sample is placed into a metal canister, which is protected with a tamper-evident seal and transferred to a controlled-rate freezer. The sample is cooled to -140ºC in a controlled manner to prevent ice crystals forming within the cells and damaging them. -140ºC is chosen as the initial end-point for freezing as it is below the critical temperature where all the physical changes that occur during freezing have completed. Once this temperature is reached the samples are temporarily stored at -160ºC before, once a day, the freezers are opened and the canister is placed in its final storage position at a temperature below -185ºC. 9

6 Your child s cord blood will only be issued for use on direct, written instruction from you (until the child reaches the age of consent); it will be used for no other purpose. Using your When should you fi rst contact Biovault? When should you apply? Once you have decided that you would like to use Biovault Family for the safe storage of your baby s At any time you feel is right in making your choice umbilical cord blood stem cells. Simply call us and of bank, but after you have had your 20 week scan. we will take you through the process. Then it is a case of the sooner the better to ensure that we have everything in place before your baby is born. You can call us or request through the website for us to call you. Frequently Asked Questions 10 If you need to use your sample all you would need to do is call us and supply us with the contact details of the consultant who will be performing the treatment. We can take care of the rest. We can transport the sample to anywhere in the world and have special shipping containers that are validated to keep the sample frozen in similar conditions to the long term storage for up to 5 days; with special arrangements it is possible to get one of these containers anywhere in the world in less than 48 hours. How does the process work? We will send you an information pack that will contain everything you need to read, complete and return to us in order to join Biovault Family. Once you are entirely happy and we have received everything we will then take the fi rst payment for the kit. We will then send you a collection kit 6 weeks before your due date for you to take to the hospital when you go into labour. How do you plan for the day of collection? When you go into labour and are using a private healthcare professional for the collection you will simply need to ring the number they have provided you with and inform them that you have gone into labour and are either in hospital or, alternatively that the midwife is in attendance. What happens after Biovault receives the cord blood? What tests do you carry out on the mother s blood? We are required by the regulations in the UK to test the mother s blood for; HIV I & II Hepatitis B & C Syphilis HTLV (human T-Cell lymphotrophic virus) 11 Once we have successfully processed and stored the stem cells we will contact you to let you know everything is OK. Once all the test results have been reported we will contact you for the fi nal payment and then send you your baby s stem cell storage certifi cate.

7 Biovault Family F Plymouth International Medical and Technology Park, 24 Brest Road, Derriford, Plymouth, PL6 5XP, United Kingdom Tel: +44 (0) Fax: +44 (0) info@biovaultfamily.co.uk www. biovaultfamily.co.uk