Page 3. pluripotent stem cell. other stem cells. blood stem cells. muscle cell. red blood cells. brain cell. other type of cell.

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2 Stem cells are naïve cells that can, with the right stimuli, transform into many other cell types found in the human body. Serving as a sort of repair system for the body, they can theoretically divide without limit to replenish other cells. When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialised function, such as a muscle cell, a red blood cell, or a brain cell. It is these properties and the fact that the umbilical cord is a rich source of stem cells that has prompted many parents to save their children s cord blood to potentially treat or prevent injury, disease, and other medical conditions now and in the future. pluripotent stem cell blood stem cells other stem cells red blood cells platelets white blood cells muscle cell brain cell other type of cell Page 3

3 Storing your newborn child s stem cells is a unique opportunity to use nature s own building blocks to treat a variety of conditions now and in the future. Current and future therapies and the family Today, more than 200,000 cord blood units have been stored and used since the first direct donation from a sister to a brother in In fact, stem cells are now standard care for many diseases. However, the real promise of stem cell therapy lies ahead of us. Research is currently underway into the treatment of a wide variety of different medical conditions including ischemic heart disease, cancer, spinal cord lesions, bone fractures, burns, strokes, multiple sclerosis, Alzheimer s disease, Parkinson s disease, Huntingdon disease and diabetes. All have shown positive results. Umbilical cord stem cells have a 1 in 4 chance of being a perfect match for a sibling and a good match to other family members. Regenerative medicine Regenerative medicine aims to restore or repair different tissues or organs which have suffered damaged using the body s own (or another person s) resources. It is a novel approach to medicine. Most therapeutic applications are still experimental or in clinical trials, but the perspective is bright and appealing. In your baby s lifetime it is possible that stem cells will be able to be a core part of this exciting field. Page 4 Page

4 Clinical trials Even with just the therapies existing today, it is estimated that the lifetime probability of undergoing an autologous (using ones own cells) transplant is approximately 1 in 200(Gluckmann 2008). However, the number and types of clinical trials investigating various diseases and disorders are increasing every year making the possibility even more likely. It is worth noting that worldwide the case for banking is considered of special importance where a sibling has a transplantable disease AND where the HLA type is unusual, eg in minority ethnic groups. In the UK, sibling transplantation is overseen by the National Health Service. Technical comment Umbilical cord blood contains many types of stem cell, these include haematopoietic Stem Cells (HSCs), Very Small Embryonic Like stem cells (VSELs), Mesenchymal Stem Cells (MSCs), Unrestricted Somatic Stem Cells (USSC). These have been shown to develop into other tissue types, for example cardiac, neurological, pancreatic and skin. Umbilical cord blood also contains high concentrations of cytokines, growth factors and hormones, B-cells and T-cells. Transfusion of whole cord blood shows faster engraftment than extracted stem cells, attributed to these components. White blood cells (B & T cells) are known to be affected by ageing, it has been proposed that...collection and cryopreservation of these (via successful development of adoptive immunotherapies in treating infections and cancer, particularly in the ageing population. (Charron INSERM U662). Key Points Umbilical cord blood is usually treated as waste. It is a safe painless process to collect and store umbilical cord blood. Matched donors can be found from public registries however for some patients the likelihood is reduced due to lack of availability of donors (eg mixed race patients). Clinical trials are on going in a number of key areas and for a number of diseases however this does not mean that treatments will be approved. Umbilical cord blood stem cells are not the same as embryonic stem cells. Page 5

5 Cells4Life is about giving parents a choice. By making clinical, scientific and evidence-based information available to parents we hope to allow them to make an informed decision about cord blood storage. We are working very hard to set the standards in the testing, processing and assessment of these precious samples. The UK is no one of the leading countries in stem cell research and development; we want to remain at the clinical forefront of this in order to benefit patients. Dr Giles L.S. Davies MB BS BSc MRCS (Eng), cofounder Cells4Life. Founded by doctors Cells4Life is a professional organisation founded by doctors. All parents receive support from our team of doctors, scientists and hospital specialists who provide the highest level of confidential care, support, advice and expertise. Only UK company to store whole cord blood Unlike other UK stem cell storage companies, we store the whole cord blood not just the extracted stem cells. Leading UK transplant services currently use whole cord blood when treating blood diseases. Work published in international peer reviewed press has shown the superior engraftment of whole cord blood transplants versus extracted stem cells. [Savarese, T.M. et al (2007) Breast Cancer Res.] Whole cord blood contains many different kinds of stem cell and other factors that may play a vital role in future medical therapies. Separation of the stem cells (volume reduction) causes many stem cell types to be lost and removes all of the other factors. Speed is critical to maximise cell viability Speed of processing is a key factor in maintaining viability of your baby s cord blood. V i To provide maximum speed and care we only a b use couriers to transport the sample from the i l hospital to our laboratory, resulting in the i t y fastest average processing time in the industry. Uniquely, we use state-of-the-art temperature Time controlled packaging where transit times may be lengthy. Additionally, we operate a 24/7 laboratory, and perform all processing in house. Page 6

6 Stringent testing On arrival at our laboratory, the sample undergoes detailed testing. This ensures that only cord blood containing a high percentage of living cells is stored. By performing theses tests at the time of processing we can provide our customers with clear evidence of the quality of the sample. Multiple samples We divide the cord blood into a number of vials. This gives maximum flexibility to potentially enable its use for different therapies over time, if needed. Stem cell amplification technologies may allow the use of smaller samples for treatments in the future. Dual storage locations In the interest of optimum security we long-term store separate samples from a single cord blood collection in two geographically remote sites. This helps to ensure that in the event of a natural or man-made disaster at one location, you will retain part of the sample intact. Human Tissue Authority license Cells4Life is regulated by the Human Tissue Authority, license number This ensures our practices meet the highest standards and are in compliance with the EU Tissue and Cells Directive and Human Tissue (Quality and Safety for Human Application) Regulations Guaranteed refund We charge an all inclusive fee, and in the event of a failure to collect or a positive testing results we will refund all fees paid except third party fees and the deposit. Complaints procedure In the unlikely event that you are not satisfied with the service please contact your Cells4Life representative. Should they be unable to answer your query they will escalate this in accordance with our documented procedure. Page 7

7 The process to store your child s cord blood is simple: If you d like to speak to one of our medical experts for more information please feel free to call us : +44 (0) Step 1 Consent Booklet The Consent Booklet in the back of this pack explains all parts of the Cells4Life service. Please make sure you are happy with this and if you have any questions please do not hesitate to call us. Cells4Life Ltd Sales and Marketing Division Sussex Innovation Centre Science Park Square Falmer Brighton BN1 9SB Step 2 Hospital appointment At your next hospital appointment, please make sure that they are aware of your desire to collect umbilical cord blood and verify the hospital policy on this procedure. If necessary, please contact us to arrange for a licensed procurer to attend the birth. Step 3 Storage Agreement We have enclosed two copies of our Storage Agreement and the Consent Booklet. These are legal documents so please read them fully, complete your details, sign and return one copy of them with your payment to us and retain the second copy for your own records. We have included a prepaid envelope for your convenience. Step 4 Collection Kit Once we receive your signed agreement, consent, payment and have verified that the procurement will be correctly carried out, you will be sent the collection kit by special delivery and this will contain full instructions. Ideally this delivery should be arranged well in advance of your expected due date. However, we can arrange a courier in the event of an imminent delivery at additional cost. Page 8

8 Step 5 Collect umbilical cord blood Following the birth of your baby and delivery of the placenta, the procurer will collect your baby s umbilical cord blood and maternal sample and package it in our specially prepared blood bags ready for collection. A maternal sample of blood will also be taken. If this is not possible then a sample should be taken within 7 days of the birth and sent to us. Step 6 Call courier Call our courier who will arrange collection from you. Please make sure that you keep the cord blood with you at all times and do not leave it at the hospital reception desk. Step 7 Courier collects the sample A courier will collect the cord blood from you and deliver it directly to our state-of-the-art laboratory in Sussex. Step 8 Testing and cryopreservation Upon arrival, we will start processing and testing. Your sample will be separated into several segments and cryopreserved. Eventually, it will be stored in two geographically separate locations. Step 9 Maternal sample testing Maternal samples are sent to a 3rd party laboratory for testing and we will test the cord blood for bacterial contamination. Step 10 Certificate of Testing After all our testing, you will receive a Cells4Life Testing Certificate for your child s blood. This provides all testing information available regarding your baby s sample. If you have any questions or require further information please call us on +44 (0) IMPORTANT NOTE Procurement of Umbilical Cord Blood may only take place under an HTA license eg on licensed premises or via a third party agreement with a licensed establishment. Breach of this requirement is an offence under HT Act 2004, Human Tissue (Quality and Safety for Human Application) Regulations 2007 Page 9

9 What is the difference between storing whole cord blood and extracted stem cells? Both whole cord blood and extracted stem cell samples start from collecting the available blood from the umbilical cord. Whole cord blood preserves all stem cell types. Extracted stem cell storage, also known as volume reduced storage, preserves only one stem cell type. What is the benefit of storing whole blood compared to extracted stem cells? Umbilical cord blood contains several different types of stem cell. These include haematopoietic Stem Cells (HSCs), Very Small Embryonic Like Stem Cells (VSELs), Mesenchymal Stem Cells (MSC), Unrestricted Somatic Stem Cells (USSC). Additionally, it contains high concentrations of cytokines, growth factors, hormones, B-cells and T-cells. Extracted stem cell samples principally contain HSCs. The other components are destroyed. Is there a downside to storing whole blood? No. Cord blood would normally be used in its entire state. If a specific therapy required certain a cell type this would be available within the sample. Are there any treatments that will only be available to me if I store whole blood? The additional cell groups in whole cord blood mean that whatever new therapies are developed you will have the best chance to take advantage of them. These groups are critical for certain therapeutic treatments, tissue reconstruction, regeneration and important for successful engraftment. Is there an upside to storing extracted stem cells? Not to the baby. Volume reduced storage was invented to reduce the cost of storage for public stem cell banks. It has been adopted by most commercial stem cell banks for this reason. Is it true that if I store a piece of the umbilical cord I will still be able to preserve MSCs and VSELs? A certain type of MSC is available in cord tissue. No trials or research have been carried out with these MSCs so it is too early to say if they will be of any therapeutic value. VSELs are not contained in the cord itself so these will not be available. Whole cord blood contains both these cells groups without the need for additional cost. Page 10

10 Why is it important to store in two locations? When storing your baby s stem cells for such a long time you want to know your investment is protected against natural or man-made disaster. Two geographically remote locations ensures you have a back up if ever needed. What method of preservation does the NHS use to store cord blood samples? Whole cord blood storage is the process used by the NHS when storing cord blood from a sibling to treat a child with leukaemia. Can we store part of the blood for our own use and the rest for public use? The average amount of cord blood collected is enough to treat a child with a haematological disease weighing up to about 30 kg. Augmentation (cell multiplication) technologies will mean that small numbers of stem cells can be expanded, but the reality is these technologies are several years away. Until this technology is proven, Cells4Life does not recommend splitting the sample. Can the cord blood still be collected if I have a caesarean or home birth? The process is the same in either case. The important thing is to discuss it in advance with your midwife and birth partner. In a caesarean birth, cord blood is collected after the delivery of the placenta in the same way as for a natural birth. Is there any medical risk to either myself or the baby? Umbilical cord collection with Cells4Life occurs after the placenta has been delivered. It is a simple, quick and safe practice. Cells4Life protocol does not add risk to mother or baby at time of birth. The person must hold an appropriate license or Third Party Agreement as required by the Human Tissue (Quality and Safety for Human Application) Regulations Blood stem cells can be stimulated to turn into other types of cells including nerve and heart muscle. This has important potential therapeutic implications for the treatment of conditions such as stroke and heart disease, the research evidence looks very exciting. Dr Jeff Drew, Scientific Director, Cells4Life Page 11

11 Why is your initial storage agreement limited to 25 years? It is highly likely that it will be possible to store the cord blood for much longer periods of time. Current research has shown that cord blood stored and used after 25 years is therapeutically viable. Peripheral blood, gametes and other tissue types have been stored and used after considerably longer periods with no adverse effects using the same techniques, therefore it is highly probable that the UCB will be able to be used after 25 years. Why is the speed of delivery and processing of the sample so important? Medical evidence shows that the viability of the cells deteriorate over time. To ensure the cord blood is stored at the optimum quality we aim for a maximum of 48 hours between collection and processing and where necessary provide unique temperature controlled packaging to maintain viability. Cell viability after: Are there any ethical considerations in collecting cord blood? No. There has been much controversy around the collection of embryonic stem cells but this is completely different and involves the extraction of stem cells from embryos usually created specifically for the purpose. The umbilical cord blood is from a living person (the child) and remains their property. Thus there is no ethical reason why it should not be preserved. My husband is a doctor and he collected the cord blood himself, he found the instructions clear and easy to follow. The courier arrived promptly to collect the blood. Page 12

12 What would happen if there were complications at birth? The wellbeing of mother and baby is always the primary consideration. Cord blood is collected after delivery of the child and the placenta it does not change or interfere with the care need at the critical time of delivery. Neither does it affect the management of the labour. However, it is made clear in both the instructions for collection and within the contract that, if there is any reason why collecting the blood sample will distract from the health of mother or baby, then the procedure will not be carried out. This may mean that from time to time making the placenta available to a trained procurer cannot occur in a timely manner. How quickly should the cord blood be collected? Timing of collection should be carried out as soon as possible after the delivery of the placenta due to the clotting process. Cord blood stem cells can be stimulated to turn into other types of cells including nerve and heart muscle. This has important potential therapeutic implications for the treatment of conditions such as stroke and heart disease, the research evidence looks very exciting. Dr Jeff Drew, Scientific Director, Cells4Life We chose Cells4Life because of their UK based laboratory and the expert, professional advice we were given. Can cord blood be used by any other members of the family? It is possible that cord blood will be a suitable match for other members of the family, and possibly unrelated recipients as well. This would require a process of HLA type matching (the same as if bone marrow or other tissues were to be donated). There is a 1 in 4 chance of a match between siblings. This decreases with each generation step away from the child. Due to the naïve nature of UCB a greater number of mismatches between the HLA types can be tolerated. This means that it is more likely for a UCB sample to be a tolerated match for any possible recipient. What s the difference between private and public cord banks? In the UK, mothers that give birth at certain hospitals can choose to donate cord blood voluntarily to the public cord bank run by the NHS. However, once this has been donated the sample will be used for anyone with a clinical need that has an HLA match to the sample. There is no guarantee that the sample will be available for use by the donor should it become necessary. Private storage is the only way to guarantee a perfect match and ready availability should your child need it. 13

13 Check with the hospital if collection is possible. Check the hospital is licensed or has a third party agreement with Cells4Life. Contact Cell4Life regarding third party to procure blood if necessary. Consult with your doctor for advice as necessary. Complete contract. Post/Fax to Cells4Life. Cells4Life Contact:... Kit will only be dispatched once a completed contract and deposit have been receipted and legal status of procurer is confirmed.

14 CONSENT BOOKLET

15 Please initial to confirm your consent to a section OR write NOT CONSENTED in the section. Please initial where marked INTRODUCTION There are two copies of this document provided in each Welcome Pack. One copy is to be kept for your records and the other should be returned to Cells4Life with the completed Terms and Conditions. The purpose of this document is to provide you with information regarding the Cells4Life services and processes and the law in the UK under which Cells4Life is licensed. This document needs to be read in conjunction but not limited to the Welcome Pack folder and the Terms and Conditions as provided by Cells4Life. You may also wish to refer to other sources of information such as the Cells4Life website, the Human Tissue (Quality and Safety for Human Application) Regulations 2007 website for legislative information, the Royal College of Obstetricians and Gynaecologists (RCOG), the Anthony Nolan Trust for public banking and policy papers and documentation provided to you by the Trust you are giving birth in. This document aims to: 1. Describe the regulatory framework and how it affects you and any decisions you make regarding procurement of your cord blood; 2. Describe the processes involved, who is responsible for each step and what the choices are; it also details what will happen if these processes are not followed and what impact this might have on the sample and you.; 3. Describe what tests will be done and when, also what the results might mean; 4. Describe when and how consent can be withdrawn; 5. Describe the steps that will be taken and what communications you will receive from Cells4Life; 6. Describe Cells4Life s current and ongoing role and responsibilities; 7. Describe your current and on-going role; 8. Record your consent to the processes and practices. This Consent Booklet is how Cells4Life will record your wishes in respect of the Cells4Life service. You need to complete this and return it to us. By law we have to verify that you are capable of providing consent and further that you are making an informed decision. This is done by means of a short phone call to review and verify the information you have provided. Please contact Cells4Life to discuss any aspect on which you may be unclear or for further information. It is strongly recommended that all parents of the Child or Children read this information and ensure they are aware of how the process works. This is important as the Mother may not be able to or may not wish to communicate instructions as to how, for instance, the courier should be notified. x

16 Please initial where marked IMPORTANT INFORMATION ABOUT THE LAW The legislation relevant to the Cells4Life service is the UK Human Tissue Act 2004 and associated Regulations, such as the Human Tissue (Quality and Safety for Human Application) Regulations The regulatory body for this is the Human Tissue Authority (HTA). Cells4Life is licensed by the HTA with license number Further information can be found at Some aspects of this law affect you even if you are not giving birth in the UK and even if you are not living in the UK. This is because the legislation governs Cells4Life. Consent and withdrawing it The law requires many items to be in place. Specifically for customers of Cells4Life we have to assure ourselves that consent is both informed and freely given. This means we have to advise you of the service, likely outcomes of each part of the service and how it progresses. Further you must have had the opportunity if you want to discuss this with other people and/or organisations and read other material relating to this. There is a Consent Form which is at the back of this booklet. Please read the whole of this booklet and then complete this Consent Form. Cells4Life will then contact you to verify that this is valid. In addition to ensuring you know about the service we need to tell you how to either refuse to consent or withdraw your consent. Simply, if you do not want to proceed with the process of collection or testing or storage at any point in time you need to contact us and let us know. We will usually ask for this to be confirmed in writing if this is given orally. x x x If you chose not to go ahead with the service after obtaining a Collection Kit and before the blood is collected you will usually only have to pay the deposit. If you choose to withdraw consent for the storage after the blood has been processed, you will usually have to pay all monies except for some of the remaining Storage Fee or Annual Storage Fee. In either case you have to be aware that the blood is not available for use at any point in time for any reason. We will ask you to complete a form which documents this. You may withdraw your consent at any time for any reason. The identity and right to withdraw must be verified before withdrawal will be recognised. This will be kept on file. We need a signature to match to the documentation we already have to confirm this. Withdrawing consent can be for all or part of the service. In the event that you withdraw your consent for any part of the service there may be implications for you and for the sample. Some examples are detailed below, however we would encourage you to contact us and discuss to ensure understanding. You may also want to discuss this with your family and other health care professionals. Page 3

17 The other critical item which can immediately affect the service is who may legally procure cord blood samples. There are two different scenarios: Please initial where marked a) Procurement in the UK b) Procurement outside of the UK The principle is the same for both. Cells4Life has to be able to provide evidence that the person who procured the cord blood is appropriately trained and licensed to do so. a) In the UK this means that the person who actually makes the sample available using the Collection Kit has to be either licensed by the HTA or working under a Third Party Agreement (TPA) with Cells4Life. As the Parents you have the choice of which person you want to do this task. You need to know: Not all NHS Trusts will allow NHS staff to procure your cord blood. Some NHS Trusts will allow staff to procure (we can advise you if you are booked in one of these hospitals) and have a TPA with Cells4Life. Some consultants are able to procure as they have a TPA with Cells4Life. These are specific to the individual and so other members of the team may not be licensed. We can advise you if your consultant has a TPA with us. Some independent midwives are able to procure where they have a TPA with Cells4Life in place. We can advise you if this is the case. Cells4Life has a TPA in place with a number of independent organisations who can provide the services of a trained and licensed individual to perform this procurement for you. If you would like to use the services of someone who is not already covered by a TPA with Cells4Life, Cells4Life will need to ascertain they are suitably trained (e.g. have phlebotomy experience and knowledge of the process and law surrounding this) before providing a TPA to them. The TPA will have to be in place before procurement can take place. Please contact us and we will be happy to work through the process for you. Cord blood donation to public banks may be possible ask if your Trust supports the NHSBT ( ) We will have advised you, where possible, of the requirements of the Trust you have named. However it is strongly recommended that you determine directly from the Head of Midwifery in writing what the policy is. These policies change and Cells4Life may not always have the most up to date information. If you prefer or need to you can contact the companies specified in the covering letter sent with the Welcome Pack to enter into an agreement with them. When we are able to confirm that your choice of individual is legally compliant (i.e. that the person who you wish to procure you Child s cord blood is appropriately trained and licensed) we will issue a Collection Kit to you. x Page 4

18 Please initial where marked x IMPORTANT: If you tell us that a specific person or organisation is procuring your Child s cord blood but the procedure is then carried out by someone else who we are unable to verify is appropriately trained and licensed we have to report this to the HTA. The HTA may require that the sample be disposed of or may require that it is exempt from human application. Further, the persons involved in the procurement may be liable for legal action by the HTA. This could be you as the Parents. Any persons involved in the unauthorised procurement of a sample commits an offence and is liable to prosecution. If the cord blood sample is to be procured by anyone other than the person you notified us of, you must ensure they are authorised to do so. THE CELLS4LIFE PROCESS Before the Birth As Parents you should read the literature provided by Cells4Life and any other organisations you obtain information from. It is important that you obtain enough information to be happy to make a decision to proceed with private cord blood storage. Once we have confirmed that the planned procurement will be legally compliant, consent has been obtained, the Terms and Conditions document agreed to and deposit paid, a phone call may be made to you to verify the consent. The Kit is then dispatched to the Parents by Royal Mail Special Delivery or other nominated courier service. This is a next day service. We are able to arrange a same day service but this is an additional cost. x The Kit will be made available at time of birth to the Procurer by the Parents and the Parents will allow only the nominated confirmed person or organisation to procure the cord blood. If this is not possible then you should not permit procurement to occur unless the alternative has been confirmed as being licensed and trained for cord blood procurement as per the Human Tissue (Quality and Safety for Human Application) Regulations If illegal procurement occurs, you need to be aware that legal action may be taken by the HTA against all parties involved in this. The Procurement process is detailed with pictures in the Cord Blood Collection Protocol inside the box briefly it is described here. What happens at the birth? Management of the birth is not to be altered, however please be aware that for a physiological third stage of labour you should request a clamp to be placed on the cord after cutting to ensure the blood sample is not lost due to exsanguination. Kit to be handed to the Procurer at the place of birth Procurement is advised to occur after the third stage of labour with the placenta ex utero, in accordance with current published guidance from RCOG. In the event medical risk assessment by the attending healthcare professional at the time of birth Page 5

19 indicates procurement should occur in utero, this will be documented. If you do not want in utero procurement to occur, you must specify this to the Procurer. Please initial where marked Procurement tools provided to be laid out (NOTE: some hospitals want this to be done in a separate room from the birth) Birth process completed and placenta made available to the Procurer Placenta is examined, needle insertion site disinfected Needle inserted into vein, blood flows into bag (NOTE: Manipulation of placenta and vein useful to improve blood flow) Line clamped and tied, needle removed from bag and disposed of Bag placed in protective packaging Maternal sample obtained, placed in protective packaging (NOTE: If this cannot be obtained (e.g. due to low vein pressure) the Maternal Sample Kit should be retained, a sample obtained within 7 days of the birth and returned to Cells4Life. Please ensure appropriate notes are made on the documentation to advise if this course of action is needed. Please ensure this is sent by recorded delivery only.) Packaging sealed and placed in box Procurer completes paperwork and places in box Box handed to Parents Parents to sign box and call the courier number to arrange collection (NOTE: Our couriers will advise when the nearest van will arrive. Collection may take several hours and at busy periods this may take longer. It is expected that all blood samples will be collected from the Parents within 12 hours. It is the responsibility of the Parent NOT the Procurer to arrange the courier collection by calling the number.) x At the lab The courier will return the blood sample(s) to the laboratory staff. This will then be processed. The Cells4Life process involves minimal manipulation, which has been shown to be better for the sample(s). This process retains all the stem cell types indentified in cord blood, as well as all the growth factors and hormones and the Cord Blood Factor known to be so beneficial in a clinical setting. Please see the Cells4Life Library on the web site for further information and the latest research papers on this. In the lab all the paperwork is checked for compliance with the legislation. The sample(s) is processed in our state of the art soft wall clean room. The sample(s) is assessed for volume and has a 20% DiMethylSulfOxide (DMSO) solution added to it in 1:4 ratio, the sample(s) comprising of anticoagulant and blood. This is the cryoprotectant - it coats all the cells and helps prevents Page 6

20 Please initial where marked x x bursting of the cells when freezing takes place. No method of freezing is 100% perfect and some cells will always be damaged however this method has been used since cord blood has been frozen and is a common factor regardless of the manipulation technique employed. There is a lot of hype surrounding the presence of red blood cells in frozen samples, with spurious claims that these are more likely to burst and cause kidney failure. Please see the Cells4Life Whole Cord Blood policy in this pack and on our web site for scientific references which demonstrate the safety and efficacy of whole cord blood storage. The sample(s) is sub-divided into a number of small vials (the exact number depends on the volume of blood collected). There will be at least TWO 2ml vials and then between ONE and THREE 5ml vials. Testing We then need samples for testing : viability analysis post-freeze analysis. bacterial analysis The analysis samples are a few drops of blood each. The remainder of the sample the majority of the blood is stored in a cryogenic bag. All the vials and the bag have a unique reference on them the ones for freezing are then placed in special boxes and subsequently frozen in a slow and controlled manner from room temperature to minus 80oC. This takes up to 24 hours depending on sample size. After this time the sample is placed in quarantine tanks until the testing is completed. The bacterial analysis sample is placed in an incubator where the nutrients provided and the warm temperature encourages any bacteria to grow. After 48 hours these are smeared onto special plates which allow any contaminants to grow and be identified. The viability of the sample is assessed that is to say that the number of living cells is counted. This is done by counting all the cells, then staining the dead cells and counting them and working out the percentage of the two numbers. In Cells4Life s opinion, samples with a viability of lower than 70% before freezing are unlikely to be of clinical use. The Maternal sample is sent to a third party lab for testing. Maternal samples are tested as required by law. The diseases which are tested for have been identified as being potentially hazardous in a transfusion / transplant setting. At present these are: HIV I and II HTLV (Human T cell Lymphotrophic Virus) Page 7

21 Syphilis Please initial where marked Hepatitis B (both the core antibody and antigen test) to determine past infection and current infection status) Hepatitis C You need to be aware that not all these are tested for in pregnancy, and therefore this may provide you with previously unknown information regarding your health status. We ask that we are able to provide this information to your doctor. If you do not provide us with the consent to do this, we will write to you advising of any positive results, and advise you to seek medical advice. You are then responsible for doing this. We will need your consent to disclose results of testing to any medical practitioner who is considering using the sample in the future. x What happens if there is a problem? In the event that there are any problems with the sample at any point you will be contacted. If Cells4Life has evidence or reason to recommend the disposal of the sample we will tell you. If it is possible for the sample to remain in storage BUT you need to be advised of possible limitations in the use of this, we will tell you. It is then your decision whether to continue storing the sample. You must realise that if you decide the sample will not be of use in the future, you will be charged for the service provided to date and only be able to reclaim the amount of money paid as a storage fee. x The only time Cells4Life will not process the sample is if the blood is not able to be processed, for instance the sample was not mixed with the anti-coagulant in the collection bag, or the sample has clotted in the collection tubing. This is because even small samples might be used with amplification technology to provide a therapeutically useful sample. This technique is currently in clinical evaluation. Amplification technology is where the stem cells are encouraged to create just more stem cells. More information can be found in the Welcome Pack folder and on our web site. Cells4Life will only provide you with confirmation of all the sample test results once full payment is receipted. We will contact you once the sample has been received and processed in the lab to confirm the blood volume and viability only, all other tests will not have been completed. x x If there is contamination then you will be asked to confirm that you realise it may affect the possibility of the sample being used. Realistically the only time anyone will have hard evidence and data for this decision will be when the person who is ill is present. Only then can all the factors of the diseases, complications, other sample availability and possible medication implications be known, however the decision as to whether to store this or not rests with you. x Paying and reporting the results Once all the details of the sample are confirmed and payment is receipted you will obtain a certificate detailing the results, Page 8

22 Please initial where marked Cells4Life will then move the sample from the quarantine tanks to the permanent storage tanks, unless there is evidence of contamination or non-compliance when it will be stored in a designated Non-Compliance tank. All the tanks used by Cells4Life are the same type that is to say these are vapour phase jacketed liquid nitrogen tanks. Storage in the vapour phase of liquid nitrogen has been shown to be the safest. The jacketed tanks have consistent temperature from top to bottom, which means the temperature of the samples is consistent. These tanks have a series of other built in safety features: the reservoir in the tanks is sufficient to ensure temperature is maintained even in the event of a power failure The supply of liquid nitrogen can be done independently of a power source The rate of liquid nitrogen usage is low because of the jacketed approach All tanks are alarmed You need to be aware Cells4Life will process and store any sample size because we believe amplification technology will be approved in the near future and thus all samples have the potential for clinical use. Samples with a low volume and/or cell viability may not be useful for, say, leukaemia in the near future. You will therefore need to look at the sample results and make a choice based on your personal beliefs and requirements for the sample as to whether you want to store it or not. x Cells4Life strongly believes that all samples will be useful in some setting the pioneers of cord blood usage have documented that even if the uses do not increase much, the chances of people using stem cells are 1 in 200 in a lifetime. We therefore do not recommend that for the future use aspect anyone destroys a sample. If you decide not to go ahead with the service, or cannot for any reason have the cord blood collected, then there may be financial implications. You will lose the deposit and any additional emergency courier fees paid. The only time this does not happen is if you have purchased the service within 7 days of this occurring. x If you have employed a third party to procure the cord blood for you then there may be fees due on this service. You need to refer to the terms and conditions of service of the party providing the service. If you cannot or do not want to provide a Maternal sample then the cord blood testing cannot be fully completed. Maternal samples need to be provided at or within 7 days of the birth by law. Failure to provide a suitable Maternal sample will mean the cord blood sample will be stored as non-compliant and may mean further testing has to be carried out before the sample can be used. This might have a cost and time implication. At present this testing would have to be by NAT PCR (Nucleic Acid Amplification Testing by Polymerase Chain Reaction). Page 9

23 If you decide you do not want the sample to be processed after it is collected by the courier you need to contact the lab immediately, but please bear in mind this process might be underway already. You will lose the deposit and courier fees. Please initial where marked If you decide that you do not want the sample to be stored on the basis of the initial test results, then you need to put this in writing. Please bear in mind that the maternal and bacterial analysis will already be underway but where possible this will be stopped. You will be charged for the service less storage fees. If you decide that the sample should not be stored at any point after processing and testing because you have been advised of a possible limitation of use due to contamination you will be refunded all fees except the deposit. If you decide that the sample should not be stored at any point for any reason, except contamination, after the sample is processed and testing complete you must tell us in writing and you will be asked to confirm that you have understood the implications of amplification technology and how this might benefit you or your Child in the future. You will be charged all fees except the remaining element of the storage fees. If you decide not to allow us to advise a medical person of any positive results, you will still be told of the results by Cells4Life. We will recommend that you tell your doctor of these results as it may impact your health and the health of others. Cells4Life does not operate a counselling service but we can advise you of where help can be found. If you do not provide us with consent to disclose the results of the testing to any medical practitioner who may need to use the sample in the future, you need to consider that this may prevent the sample from being used. It may delay the use of the sample and therefore the treatment whilst other alternatives are found and investigated. x Should any part of the service not be available due to your decision to withdraw consent we will advise you. Your consent to the various parts of the service is recorded by your completion of the Consent Form at the end of this booklet. This is separate from the Terms and Conditions. Please be aware that due to the nature of birth we ask that the expected birth partner also reads and consents to certain sections. This is especially important regarding the procurement and making the Kit available to persons. This is because of the legal implications of unlicensed procurement. Please discuss this service with your family, friends and medical practitioners. You will need to confirm certain aspects for your self, for instance the necessity of a third party to procure and ability for the third party to gain access to the hospital at the time of the birth. Cells4Life will provide you with as much assistance as we can in this issue. Please refer to the covering letter sent with the Welcome Pack where we will have detailed any information we are already aware of which can assist you in this. x Records and Disposal Cells4Life maintains a register of hard copy and electronic copy of all pertinent information as proscribed by The Regulations. This will include the consent, test results and information relating to the processing of the sample. Page 10

24 Please initial where marked Any personal or medical information about you collected in connection with the service will be treated as confidential and will be kept in accordance with relevant legislation and disclosed only in circumstances permitted by law. Testing will be undertaken in accordance with the current legislation to safeguard you. In the event the sample has to be destroyed, this will be done by autoclaving and incineration via an appropriately licensed third party in accordance with the medical waste legislation in force at the time. The sample is only identified by the number on it, and linkage of the names to the numbers only occurs on the contract and on the electronic register. The confidentiality of these is maintained by both physical and technological security measures. x The paper records are required to be maintained for specified periods and Cells4Life will maintain these records accordingly. Questions You are entitled and encouraged to ask us questions about any part of the service which you do not fully understand. It is very important that you do not give your consent until all your questions have been satisfactorily answered. We will contact you upon receipt of your consent to verify that you fully understand what it is you are consenting to and that all your questions have been answered. Signature Date Page 11

25 MEDICAL INFORMATION Name of General Practitioner and address of surgery: Elective caesarean/normal delivery planned: Caesarean / Normal (Please delete where appropriate) Please answer the following to the best of your knowledge. Please give details where you have answered Yes in the Comments section. Does your family have any history of inherited blood disorders? Are you diabetic (indicate if this is gestational diabetes)? Have you ever had any form of cancer? Have you ever had an organ transplant? Have you ever had a blood transfusion? Have you ever been at risk from contracting blood borne disease e.g. by needle stick injury or IV drug use? Have you ever had a sexually transmitted disease? Do you have or are you at risk from HIV / AIDS? Do you have Hepatitis (please specify type)? Have you ever had hepatitis if so which type? Have you had a tattoo in the past 12 months? Do you or a blood relative have Creutzfeld-Jacob Disease (CJD)? Have you ever had tuberculosis? Has this pregnancy been conceived using donated eggs and/or sperm? Any other inherited disorders? Yes No Comments: (Please use separate page(s) for additional comments) Page 12

26 STEM CELL STORAGE AGREEMENT

27 Dear Parents This is the Cells4Life stem cell collection, testing and cryopreservation agreement and it is a legal document. We request that you read it very carefully as it sets out the entire agreement between us. All of your information will be held in strict confidence. For your reference, this document is divided into the following parts: SECTION 1 SECTION 2 SECTION 3 SECTION 4 CUSTOMER INFORMATION STEM CELL STORAGE PRICE PLANS CORD BLOOD COLLECTION, TESTING AND CRYOPRESERVATION AGREEMENT PAYMENT METHODS Please complete Sections 1 to 4 fully and return the agreement to us and keep the copy for your own records. The Cells4Life cord blood collection protocol is for your reference and will be provided in the Cells4Life Collection Kit. If you have any questions please do not hesitate to contact us. Yours faithfully Wayne M Channon Chairman

28 Section 1 Mother s details: Mother s name: ( Mother ) Date of birth: Mother s address: Postcode Country: Home telephone: Mobile telephone: Work telephone: Fax: address: Father s details: Father s name: ( Father ) Father s address: (if different) Postcode Country: Home telephone: Mobile telephone: Work telephone: Fax: address: Birth details: Name of procuring organisation: Name of procurer: Estimated delivery date: Name of delivering hospital: Name of midwife: Name of obstetrician: Page 3

29 Section 2 Both the Premium Storage Plan and the Annual Storage Plan include the industry leading Cells4Life package: The Cells4Life blood collection kit Cord blood screening/testing Maternal blood collection kit Maternal blood screening/ testing Courier service Testing certificate Viability testing Access to advice from a Viability report medical professional If you would like to opt for one of our Prepaid storage plans which include 25 years of storage, please complete the options on this page by ticking the relevant boxes. If you prefer to pay each year for storage under our Annual payment storage plans, please complete the options on the next page by ticking the relevant boxes. For both storage plans we offer a 6 or 12 month spread payment option. Prepaid storage plans Premium Storage Plan 1,585 A deposit of 195 is payable on booking and the remainder on successful storage of your child s stem cells. This option includes a Storage Fee of 350 for 25 years storage. Twins Premium Storage Plan 2,430 This is a discount of 740 to help towards the cost of having twins. A deposit of 390 is payable on booking and the remainder on successful storage of your children s stem cells. This option includes a Storage Fee of 500 for 25 years storage. Options Spread payment options If you wish to use our spread payment facility, please select either of the options below and complete the Standing Order form on page 14. Payments to start the month after order placed. 6 month payment plan 80 Total to pay is 1665 ( ). Deposit of 195 payable with booking and 5 equal monthly instalments of month payment plan 160 Total to pay is 1745 ( ). Deposit of 195 payable with booking and 11 equal monthly instalments of Phlebotomy service (Payable with deposit) Single birth 210 Multiple birth 265 Existing Cells4Life customers As a token of our appreciation for making Cells4Life your preferred stem cell services company, we offer you a discount of 150 for each child after your first. Total to pay All deposits are non-refundable Page 4