Guideline for parents. Information on the storage of umbilical cord blood and umbilical cord tissue.

Transcription

1 Guideline for parents. Information on the storage of umbilical cord blood and umbilical cord tissue. sicher erstklassig innovativ

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3 When we were about to become parents, we were really excited and Friends of ours who already had children told us about the stem cell bank Vita 34 and we gathered more information. Stem cells from umbilical cord blood? What is that? What do you need them for? What can you treat with them? And store them? Does that make sense and how much will that cost? Vita 34 answered all our questions and convinced us. We had Melina s stem cells stored with Vita 34 right after her birth. And while Melina grows older every year, her stem cells remain young had many new things to consider. It was unbelievably thrilling and it took us a long time until we knew what was important to us. and perhaps may help her in the future. That makes us feel safe, even though we hope that our baby girl will never need them. Katja and Enrico Könze, Melina s parents

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5 04 Stem cells Stem cells are viable all-rounders The potential of stem cells from umbilical cord blood Storage The safe way to stem cell storage How it works Vita 34 Licenses broaden opportunities of use Enable the medicine of the future Foresight of everything to come Stem cell storage in the glass laboratory Just in case Vita 34 will be there for you Services & prices Summary of Vita 34 packages Our service promises Financing options General Terms and Conditions Guideline for parents

6 Stem cells change our world Vita 34 paves the way. Dr. André Gerth, CEO of Vita 34 AG

7 10 Stem cells Guideline for parents

8 Guideline for parents Stem cells Stem cells Stem cells are the building blocks of life. An entire human being develops from the initial stem cell the fertilised egg cell. Through reproduction and differentiation, they form more than 200 different types of cells: e.g. blood, muscle, and nerve cells. Stem cells are viable all-rounders Stem cells repair and regenerate for their whole lives long and thus help us to overcome diseases and injuries. Young stem cells are the most powerful, that is why fractures and wounds in children heal so much faster than in adults. As they get older, however, the viability of stem cells subsides. In view of an ever increasing life expectancy, it is even more important to take care of tomorrow today and permanently secure these all-rounder cells. Stem cells Muscle cells Blood cells Skin cells Bone cells Cartilage cells Myocardial cells Nerve cells Cells of vascular walls Liver cells The treasure in umbilical cord The blood circulation of the unborn child in the last third of pregnancy contains particularly viable stem cells. That is why you will find millions of these virus-free stem cells in blood and tissue of the umbilical cord. They can be easily collected without causing pain and are, other than embryonic stem cells, ethically unobjectionable. 4

9 05 Stem cells Guideline for parents These particularly young stem cells can become a variety of cell types. All new blood cells, the body s natural immune system as well as other organ tissues develop from stem cells contained in umbilical cord blood. Umbilical cord tissue contains a particularly high concentration of mesenchymal stem cells. Because of their ability to develop into connective tissue, muscles, cartilage, and bones, they are very interesting for the regenerative medicine. In contrast to stem cells from bone marrow, stem cells from umbilical cord blood and tissue are free of impairments caused by age and environment. The potential of umbilical cord stem cells Stem cells are able to renew and copy themselves through cell division. This and their ability to develop into specialised cells make them extremely interesting for the medicine. Application of stem cells today Stem cells from umbilical cord blood were already transplanted in cases of leukaemia. They were applied in the treatment of juvenile diabetes, infantile brain damage, and haematopoietic disorders (aplastic anaemia), the correction and regeneration of the immune system, and the reconstitution of haematopoiesis after chemotherapy. Opportunities in medicine The full potential of stem cells cannot be fully estimated yet. Researches expect that entire organs can be made of stem cells in the future. We can already hope for that at this stage: young and clean stem cells are the best basis for the future in medicine. The ever growing knowledge in research, obtained also with the help of Vita 34, makes your child s stem cell deposit more valuable every day.

10 Guideline for parents Stem cells About half of the applications registered with Cord Blood Europe were performed using preparations stored at Vita 34 (as at July 2013). Technical knowledge and experience in the application of stem cell preparations make Vita 34 the expert and competent partner for stem cell storage. Application of umbilical cord blood in Europe 44 % preparations from Vita % preparations from other stem cell banks 36 % for the regeneration of haematopoiesis in case of blood disorders and immunological diseases 36 % in the therapy of brain damage (treatment attempts with autologous umbilical cord blood) 28 % in the treatment of diabetes type 1 (clinical study) COMPACT INFORMATION Stem cells from the umbilical cord can develop into different types of cells, were already applied in various therapies, studies, and treatment attempts, are the optimal basis for future regenerative therapies and can be collected in a simple and no-risk procedure only at birth. 6

11 Stem cells Guideline for parents 14

12 Guideline for parents Storage Storage The collection and storage of umbilical cord blood and tissue carries great opportunities. And your effort is only minimal. Excellent performance creates the source material for a stem cell preparation complying with pharmaceutical quality standards. The safe way to stem cell storage As an experienced service provider, Vita 34 is your competent partner, for the storage of umbilical cord tissue as well. We have done our utmost to develop reliable materials and processes so that stem cells of top quality are available to your child in many years. Collection We will send you the Vita 34 collection package in good time before the delivery. It contains everything that is necessary to collect blood and tissue in aseptic packaging. We have trained doctors and midwifes in almost every birth centre in Germany and they know what to do. Immediately after the cord was cut, the blood from the umbilical cord is collected in a blood bag and then the umbilical cord placed in a special container with nutrient solution. Transport Umbilical cord blood and tissue together with the required documents are securely stored in the collection package. Its temperature stability is TÜV-approved. A trained courier transports the package as quickly as possible from the clinic to the laboratory of Vita 34. Storage At the laboratory, umbilical cord blood and tissue are processed to become top-quality source material for stem cell preparations according to the GMP standard, the manufacturing practice to assure quality. The biological clock of the stem cells stops for the time they are preserved at a temperature of -190 degrees Celsius. Read on the next two pages about the detailed processes at the laboratory. 8

13 09 Storage Guideline for parents How it works: 1 Acceptance The courier hands the collection package containing the umbilical cord blood and tissue over to Vita 34 at the acceptance laboratory. This is where the first checks for external intactness, completeness of the accompanying documents, and temperature measurement are performed. All work steps are documented in detail. 2 Preparation Umbilical cord blood and tissue are prepared for being processed in the clean room. All the details of mother, child, and stem cell preparation are recorded, including name, time of delivery, birth centre etc. The assignment of an ID number enables the clear allocation of test results, preparation, and child. 3 Clean room The clean room can be entered through air locks only. The technical assistants work under sterile conditions and prepare blood and tissue for the cryo-preservation wearing special clothing. For this purpose, the components are filled into cold-resistant storage bags and a special solution is added which helps the cells to maintain their viability even at the lowest temperature. Small samples of blood and tissue are retained for required tests.

14 Guideline for parents Storage 4 Freezer room The preparations are protected by aluminium caskets initially cooled down to -145 degrees Celsius in special freezers. Finally, they are stored in cryo-tanks filled with nitrogen at -190 degrees Celsius. 5 Cryo-store Each tank in the storeroom is temperature-monitored and operated grid-independently. The aluminium caskets are arranged in a shelf system in the tanks. The cryopreserved umbilical cord blood and tissue can be quickly procured and prepared for application. 6 Cell culture and haematology The nucleated cell count is obtained as well as an infection with viruses and bacterial contamination excluded. The child s blood type is determined. 0

15 Stem cells Guideline for parents 18

16 Guideline for parents Vita 34 Vita 34 Vita 34 has been storing umbilical cord blood for more than 16 years and therefore is the largest and most experienced stem cell bank for private storage in the German-speaking countries. Our practical applications, research, and innovations have set standards and make Vita 34 the specialist for stem cell storage. Vita means life. The number 34 stands for the cell-surface molecule CD34 that characterizes haematopoietic stem cells. The name Vita 34 reflects the company s vision of protecting life by storing stem cells. Given the number of applications in clinical treatment attempts and studies, Vita 34 is the most experienced stem cell bank in Europe. It is furthermore the largest one in Germany with more than 16 years of experience. Vita 34 stands out due to a highly qualified team of specialised physicians, chemists, biologists, and biotechnologists. Parents of about 98,000 children have stem cells stored with the specialist Vita 34. Vita 34 wants to provide the private stem cell storage to many parents-to-be for their children and therefore maintains a wide network of birth centres in Germany. Almost every birth centre and hospital in Germany cooperates with Vita 34. Security for sensitive stem cells Vita 34 guarantees the reliable long-term storage for the stored stem cells to be available in top quality even after many years, if worse comes to the worst. High quality standards and safety regulations are complied with from collection to permanent cryo-preservation according to strict official specifications. Licenses broaden opportunities of use Storage and application of stem cells from umbilical cord blood and tissue are licensed by the Federal Institute of the Federal Ministry of Health under strict conditions. Vita 34 supports the broad-ranging application of valuable stem cells and therefore offers more possible applications of Vita 34 stem cell preparations than most private stem cell banks: for your child, its siblings, and other relatives, to help others within the scope of VitaPlusDonation, and only at Vita 34 with stem cells from umbilical cord tissue. 2

17 13 Vita 34 Guideline for parents Storage of valuable umbilical cord tissue Vita 34 complies with the high official standards regarding the storage of umbilical cord tissue in Germany. This tissue contains particularly large quantities of mesenchymal stem cells. Tissue stem cells can predominantly become cartilage, bone, muscles, and connective tissue. That makes tissue from the umbilical cord so valuable for the regenerative medicine. By choosing the option VitaPlusNabelschnur, parents can secure the potential of stem cells from umbilical cord and tissue thanks to the research of Vita 34 nothing gets lost.

18 Guideline for parents Vita 34 Help others with VitaPlusDonation VitaPlusDonation provides you with two options: You can on the one hand provide your child with a private stem cell deposit and, on the other hand, you can make these stem cells available to another sick person in an emergency. If your child s umbilical cord blood is needed, Vita 34 will inform you. You decide whether you want to continue the storage of your child s blood or release it. VitaPlusDonation is an additional option at no charge. You only pay for the storage of the umbilical cord blood according to the selected type of contract. If you decide to donate the blood, Vita 34 will refund all the paid storage fees with interest. With its nationwide network of birth clinics, Vita 34 renders donating for many parents-to-be possible, thus increasing the variety of available donor cells. With the public register of donations Vita 34 provides access to each physician and each concerned person searching for an adjuvant preparation. Children help each other with the sibling initiative There are diseases such as leukaemia, for the treatment of which the child s own stem cells are not the first choice. If possible, stem cells of healthy siblings are used. Vita 34 therefore stores the umbilical cord blood of a healthy newborn for five years at no charge, if according to a medical certificate it could be used to treat a sick sibling. The sibling s blood stored at Vita 34 by way of precaution has already facilitated the transplantation of stem cells in older siblings a few times. 4

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20 Guideline for parents Vita 34 Enable the medicine of the future Research and development are priorities for Vita 34, because the stem cells from your child s umbilical cord blood and tissue can be a precious commodity. That is why Vita 34 contributes decisively to progresses in stem cell medicine. Highest safety and quality standards throughout the entire process as well as numerous research projects reflect the innovative approach of Vita 34 including proprietary material developments setting standards on their own. It is best to develop the best by oneself Vita 34 has developed reliable materials and processes to ensure the particularly high quality of the stem cell deposit. Midwifes and doctors trained by Vita 34 have collected umbilical cord blood about 98,000 times. To ensure a maximum safety, a proprietary collection kit was developed for this purpose. As the blood bag complies with the standard for being applied in operating rooms, it can also be used for Caesarean sections. The innovative Vita 34 collection package in addition is storage box and temperature-monitored transport container in one. A special cold-resistant and extremely fracture-proof freezing bag is included in the patented bag system. This is the result of intensive, specific research. The safety and quality of the preparations is of top priority for Vita 34. Vita 34 drives the development There is currently a variety of studies all over the world researching stem cells: More than 200 clinical studies alone are based on umbilical cord tissue. Reputable scientists advocate the medical potential of stem cells from umbilical cord blood and tissue. To be able to better understand the variety of effects of these highly viable cells, Vita 34 plays an active role in research processes, is involved in basic and applied research, and cooperates with renowned universities and institutions. Vita 34 thus has a maximum of knowledge you can trust in. 6

21 17 Vita 34 Guideline for parents Vita 34 stands alongside strong partners for stem cell research Applied research Stem cell therapy in case of stroke Stem cell therapy in case of heart attack Stem cell therapy in case of Fallot s tetralogy (congenital heart defect) Stem cell therapy in case of type 1 diabetes (study phase I) Stem cell therapy in case of immune response after transplantation of blood stem cells Establishing and assessment of stem cells for tissue repair Basic research Reproduction of stem cells from umbilical cord blood Differentiation of stem cells from umbilical cord blood Therapeutic properties of adult stem cells, depending on the age of the cell population and the recipient organism Use of non-freeze proteins for the cryo-preservation of umbilical cord blood Use of umbilical cord blood to produce induced pluripotent stem cells, i.e. re-programmed cells with a higher potential of differentiation

22 8 Guideline for parents Vita 34

23 19 Vita 34 Guideline for parents Foresight of everything to come Vita 34 acts foresightedly and therefore takes provisions by means of important decisions. Storage of whole blood for future opportunities Vita 34 deliberately relies on the storage of whole blood. If the stem cells are separated from the blood prior to the storage, this may lead to the unintended loss of valuable cell populations. As your child s stem cell deposit is to be prepared for any future developments, we trust in the storage of whole blood preparations. Protection for half a century including insolvency insurance The stem cell deposit of your child is at any rate in safe hands with Vita 34. For the improbable case of insolvency, Vita 34 has secured the stored preparations by means of a comprehensive insurance cover to guarantee the storage and professional monitoring of each preparation for 50 years. Our insurance partners Generali and HDI-Gerling will provide for the ongoing storage of the preparations in compliance with the high quality standards in such a case.

24 Guideline for parents Vita 34 Stem cell storage live at the glass laboratory At Vita 34, you can look over the lab technicians shoulders. Interested parents are invited to tour the glass laboratory. You can see live how stem cells from umbilical cord blood and tissue are placed in deep sleep and watch all the steps from acceptance to freezing. Please register for the free tour by phone or by . You can also experience a virtual 360 panoramic tour through the glass laboratory on 0

25 Vita 34 Guideline for parents Just in case Vita 34 will be there for you Combining a nationwide network of clinics, competent specialist counselling, and an excellent stem cell team, Vita 34 offers services that will convince you. More than 95 percent of all birthing institutions are regularly trained Vita 34 has an impressive, nationwide network of clinics and cooperates with over 95 percent of all birth centres in Germany. This makes the collection of umbilical cord blood and tissue possible in almost every clinic. Our employees regularly train physi-

26 Guideline for parents Vita 34 cians and midwifes personally. We thereby ensure that a high level of quality of the services provided by Vita 34 is observed, beginning with the collection. The Vita 34 specialist counselling service makes complicated simple Whatever questions you may have, the qualified employees of the Vita 34 specialist counselling service will answer them at any time: for example regarding the completion of medical documents, questions on the relevance of previous diseases, or discussing the results of the comprehensive quality tests. Vita 34 wants to make sure that you have a good feeling all around your decision to store stem cells. The Vita 34 team of experts supports you in the communication with physicians in case the stem cells are applied. The Vita 34 stem cell team is on duty in emergencies Vita 34 has developed finely tuned logistics and set up two stem cell teams of experienced employees for the quick transport in case of application. The specially trained and qualified personnel transport the frozen stem cell preparation in a special container the so-called cryo-shipper to the clinic. Thanks to mobile clean room technology, the stem cell teams are able to process the preparation for the transplantation on the site upon the physician s request. The stem cell bank Vita 34 COMPACT INFORMATION is most experienced among the private German umbilical cord blood banks because of the number of released stem cell preparations, ensures the quality of collection, processing, a cryo-preservation by means of proprietary developments, broadens the possible applications through active research, has provided about 98,000 children with their own stem cell deposit already. 2

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28 Guideline for parents Services and prices Services and prices Deliberate decisions are made on the basis of wide information. Take advantage of the one-time opportunity to store your child s stem cells. Our comprehensive preventive screening test provides you with additional safety, and you can save a lot by paying in advance. Summary of Vita 34 packages VitaPlus Store umbilical cord blood VitaPlusCordTissue Store umbilical cord blood and tissue VitaPlus Non-recurring: 1.990,00 Annual fee: 48,20 VitaPlusCordTissue Non-recurring: 2.490,00 Annual fee: 72,20 VitaPlus25* Advance payment for 25 years Package price: 2.595,00 Annual fee as of age 26: 48,20 Saving 600,00 VitaPlusCordTissue25* Advance payment for 25 years Package price: 3.395,00 Annual fee as of age 26: 72,20 Saving 900,00 VitaPlus50* VitaPlusCordTissue50* Advance payment for 50 years Saving Advance payment for 50 years Package price: 3.500,00 900,00 Package price: 4.800,00 Annual fee as of age 51: 48,20 Annual fee as of age 51: 72,20 OPTIONAL + Preventive screening test DNA testing for health risks: 390,00 Saving 1.300,00 OPTIONAL VitaPlusDonation Free option of public donation * You can save a minimum of 600 Euros compared to the annual mode of payment by paying the annual fee for the first 25 or 50 years in advance. The General Terms and Conditions apply (page 22 27). 4

29 25 Services and prices Guideline for parents Our service promises This is what you can expect. Expert counselling by medical specialists Experts from the fields of medicine and biology provide you with professional advice and support in all medical issues regarding stem cell deposits. Detailed anamnesis and assessment by our physicians Careful recording and assessment the medical history of your family is required by the health authorities. This is intended to serve the safety of your child in case of application. Vita 34 physicians clarify by means of the medical history form and the findings included in the maternity card how stem cells from umbilical cord blood can be applied later from a medical point of view. Temperature-protected collection package containing the Vita 34 collection kit The safety packaging with gel pads stabilising the temperature, insulating polystyrene box, and chip permanently monitoring the temperature optimally ensures the quality of the blood during the transport. The package contains the Vita 34 collection kit, which is specifically designed for the safe collection of stem cells from umbilical cord blood during normal deliveries and Caesarean sections, as well as a disinfection box for the collection in compliance with the quality standards. Collection of stem cells from the umbilical cord only by trained personnel at hospitals Vita 34 makes sure that your birthing clinic complies with the requirements of pharmaceutical law regarding the collection of stem cells from umbilical cord blood and trains midwifes and physicians on location. So far, more than 95 percent of the birthing clinics were qualified for the collection and over 28,500 training certificates issued. The payment of the collection team is included in the contract fee.

30 Guideline for parents Services and prices Transport by special courier 365 days a year The courier hotline is open 24 hours 365 days a year to ensure the transport of umbilical cord blood and tissue to the Vita 34 laboratory even on weekends and bank holidays within the period of time recommended by the German Medical Association. Processing in clean room (GMP standard) The umbilical cord blood and tissue is processed at the Vita 34 safety laboratory according to GMP standard (GMP: Good Manufacturing Practice the highest quality standard for pharmaceutical manufacturers). The preparation is carried out in a specifically protected clean room area with strictly restricted access. Computer-controlled cryo-preservation in Vita 34 freezing bags Blood and tissue are stored in particularly fracture-proof freezing bags that were specifically designed by Vita 34. If the quantities of blood and tissue are rather high, they are stored in several bags at no extra charge. The blood is frozen in six portions (one main bag, five retain samples). Each bag is placed in a cassette that ensures uniform and safe freezing and storage. The bags are permanently stored in grid-independent cryo-tanks at -190 degrees Celsius. Quality tests in compliance with official requirements Maternal and umbilical cord blood are thoroughly tested for the required quality parameters. The results verify that blood and tissue can be applied in case of diseases. The quality tests take several weeks and comprise the following relevant steps. Umbilical cord blood is tested for: nucleated cell count, blood type, sterility, infection markers (HIV 1 RNA, hepatitis C RNA, hepatitis B DNA, parvovirus B19 DNA, cytomegalovirus DNA). If necessary, e.g. in case of a positive sterility check, Vita 34 will perform additional tests. Maternal blood is tested for: HIV 1/2 antibodies/ p24 antigen, TP antibodies, hepatitis Bs antigen, hepatitis Bc antibodies, hepatitis C antibodies, HTLV I/II antibodies. If necessary, tests to verify individual parameters are done. 6

31 27 Services and prices Guideline for parents Forwarding and explanation of findings/certificate Vita 34 will send you the test results. You can call our expert counselling service if you have any questions. Then you will be sent the certificate of successful storage. 7,000 family support if the stem cells are applied If stem cells are applied within the scope of cancer therapy in the first 20 years of life of your child, then Vita 34 will grant you a one-time payment of 7,000. You can use the money irrespective of the therapy costs covered by your health insurance without providing any bills or receipts, e.g. in order to accompany your child to the place where the stem cell transplantation is performed. Tissue typing prior to application within the family To apply stem cells in another human, it is required that as many of the tissue (HLA) characteristics correspond to each other as possible. Prior to applying stem cells from umbilical cord blood within the family, Vita 34 will bear the expenses for the necessary tests (HLA typing). Transport of stem cells from umbilical cord blood to treatment centre If your child s stem cells are applied, you will be provided with comprehensive services. Vita 34 helps you completing forms and talking with physicians. The mobile stem cell team of Vita 34 transports the cryo-preserved stem cells in a special container to the clinic (at no charge within Germany) and assumes the professional preparation of the stem cells. Insolvency insurance for 50 years As a private stem cell bank, Vita 34 is independent of the influence of public sponsors and subsidies and thus decisions which might impair the storage duration or quality. The insurance by the HDI-Gerling Industrie Versicherung AG is furthermore integral part of the performance. In case of insolvency, they will provide the financial funds to make sure that your child s stem cell preparations will remain professionally stored and monitored until the age of 50. This form of insurance is unique!

32 Guideline for parents Services and prices Unlimited contract period Each contract has an unlimited period, as the provision for the health of your child is to be maintained for a lifetime. Fixed annual fee The annual fee is a fixed amount. The terms of the contract guarantee that the annual fee can be adjusted only as of the 21 st year in accordance with the officially established rate of price increase plus increased taxes that have accumulated since the beginning of the storage. If a contract option including advance payment is chosen, this applies as of the 26 th or the 51 st year. Guaranteed price for 5 years for another stem cell deposit If you open a stem cell deposit for another child within five years, Vita 34 guarantees you the same price as for the first deposit including the same services irrespective of price adjustments made in the meantime. At least 150 Euros loyalty bonus for another stem cell deposit For a second stem cell deposit, you will be granted a discount of 150 Euros. The discount for the third deposit amounts to 300 Euros, for the fourth one 450 Euros. As of deposit number five, the storage will not be charged anymore except for the annual fee. Special conditions for multiple births (e.g. twins or triplets) The contract fee for the second child amounts to only 50 percent and is not charged at all for the third and every following child. If you choose a contract type without advance payment, an annual fee is raised for each child. Express service When time is of the essence, Vita 34 will send you the collection kit overnight on short notice for a small fee. All you need to do is call. 8

33 29 Services and prices Guideline for parents Preventive screening test Genetic dispositions to possible health risks can be determined from the DNA by means of modern procedures. However, such a disposition does not mean that health problems have to occur. Disease symptoms usually develop only in combination with outside influences. The preventive screening test at extra charge includes the additional testing of the umbilical cord blood DNA for selected risks, which may be of importance for the health of your child during adolescence. Drug-induced hearing loss (antibiotics intolerance) If the respective genetic disposition is available, the intake of certain antibiotics may cause hearing loss. Doctors may then prescribe another antibiotic. AAT deficiency (dysfunction of immune system) If the body s own inhibitor AAT is not available in sufficient quantities, disorders of immunometabolism are the result. If not treated, this may lead to damage to lungs and liver. One of 2,000 children is affected by this AAT deficiency. If recognized early, it can be balanced by means of an AAT drug. Health damage can thus be prevented in combination with other preventive measures. Haemochromatosis (iron overload disease) In one of 350 children, the body absorbs too much iron from the food, stores it in the organs, which may cause damages. If diagnosed early, you can treat the disease very well and organ damage can be prevented. Lactose intolerance Milk sugar (lactose) found in milk products, is split in the small intestine by the enzyme lactase to be absorbed. In the first years of life, this enzyme is fully developed to be able to digest mother s milk. In case of lactose intolerance, the development of lactase may reduce so that less or even no milk sugar is tolerated. Consequences are

34 Guideline for parents Services and prices e.g. indigestion, abdominal pain, diarrhoea, or vomiting. If the risk is available, your doctor may give you dietary tips or recommend preventive measures. Gluten intolerance (cereal flour intolerance) Gluten is a protein composite found in the seed of cereal. There has been an increasing intolerance of this protein for some time. The symptoms often are digestion troubles. We know that 95 percent of the affected people show a specific genetic constellation. If this is known, your doctor may be quicker to initiate further tests and to recommend changing your diet to gluten-free, if symptoms occur. VitaPlusDonation Requirements to participate in VitaPlusDonation If you have expressly agreed to the VitaPlusDonation on the order form, Vita 34 will check by means of the medical history (anamnesis), quality tests, and other parameters, whether the umbilical cord is suitable for donation. In addition, the HLA type (tissue characteristics) is determined. When assessing the medical history of the family, certain issues such as the intake of certain drugs have to be taken into consideration, that play no role in the health care of your own child. How VitaPlusDonation works If the stem cells of your child match a patient, the doctor responsible for this patient will inquire whether the preparation is available, which you will be promptly informed about. Only if you agree to the release of the umbilical cord blood in writing, Vita 34 will initially do further tests. If the umbilical cord blood is actually transplanted, Vita 34 will refund the full amount of fees paid so far plus interest. 0

35 Services and prices Guideline for parents Financing options Choose a financing model that suits your possibilities Choose the monthly instalment that fits your budget best. Or do you want customized, individual financing? Just give us a call. You can reach the Vita 34 customer service at the telephone number (free of charge). Simple, safe, and flexible: Six good reasons in favour of the Vita 34 financing 1. No interest to be paid, if you pay the amount in 12 monthly instalments. 2. No hidden costs. 3. Uniquely favourable conditions, maximum interest rate of 6.9 percent. 4. Premature repayment possible at any time no prepayment penalty. 5. The remaining credit amount is remitted, if the credit borrower with the main income dies. 6. You can adjust or suspend instalments. Examples of financing options on good terms VitaPlus VitaPlus25 VitaPlus- CordTissue VitaPlus- CordTissue 25 Non-recurring 1.990, , , ,00 Annual fee 48,20 72,20 Preventive screening test 390,00 390,00 390,00 390,00 Financing amount Interest 2.185, , , ,00 (excl. down-payment) 12 monthly instalments 0,0 % 182,08 232,50 223,75 299,16 24 monthly instalments 3,9 % 94,75 120,99 116,43 155,68 36 monthly instalments 3,9 % 64,36 82,18 79,09 105,75 48 monthly instalments 3,9 % 49,19 62,81 60,44 80,82 60 monthly instalments 3,9 % 40,08 51,18 49,26 65,86 72 monthly instalments 6,9 % 36,94 47,17 45,40 60,70 84 monthly instalments 6,9 % 32,67 41,72 40,15 53,68 96 monthly instalments 6,9 % 29,46 37,62 36,21 48, monthly instalments 6,9 % 25,04 31,98 30,77 41,15 For further financing options e.g. payment in advance for 50 years please visit

36 Guideline for parents Services and prices General Terms and Conditions Preamble Preamble (1) Vita 34 AG (hereinafter referred to as Vita 34) pursues the collection, processing and storage of umbilical cord blood and umbilical cord tissue. (2) The child as the owner shall be solely entitled to the power of disposal of the umbilical cord blood preparation; the use by Vita 34 or third parties shall be excluded. Until it reaches the legal age, the child shall be represented by the persons having the care and custody (hereinafter referred to as legal representatives ). (3) Umbilical cord blood is the foetal blood from the placenta and the attached umbilical cord that is collected immediately after the umbilical cord was cut. Umbilical cord tissue is collected by cutting the umbilical cord a second time near the placenta after the umbilical cord blood was cut and the umbilical cord blood collected. The full extent of future applications of umbilical cord blood and umbilical cord tissue cannot yet be foreseen at present. (4) The umbilical cord blood and umbilical cord tissue is processed and stored at the company s GMP (Good Manufacturing Practice pursuant to the EU GMP guidelines for medicinal products for human and veterinary use) laboratory. Umbilical cord blood is subject to the German Pharmaceuticals Act (AMG). Vita 34 has the manufacturing license for the collection and storage of umbilical cord blood pursuant to 13 AMG, and the manufacturing licenses for the collection and storage of umbilical cord tissue pursuant to 20b and 20c AMG. The collection of umbilical cord blood and umbilical cord tissue requires the availability of a manufacturing license for the birth centre as well. If the delivery takes place in a birth centre that does not collaborate with Vita 34, Vita 34 shall be exempt from all obligations resulting from this contract, as their fulfilment has become impossible on legal grounds. 1 Object of the contract (1) The object of this contract is the collection and preparation of umbilical cord blood and, if applicable, umbilical cord tissue, the storage of the umbilical cord blood preparation and, if applicable, umbilical cord tissue as well as the services included in the selected type of contract (as of 1/10/2013). Professional processing and the release to the prescribing physician / other user shall be an object of the contract with regard to umbilical cord blood. The therapeutic application of the umbilical cord blood and/or umbilical cord tissue preparation shall not be the object of the contract. (2) If VitaPlusDonation is selected, the data of the umbilical cord blood will be prepared in anonymous form and entered in a stem cell registry, subject to its corresponding suitability. The legal representatives shall agree to HLA typing of the child s umbilical cord blood. If the other tests of the umbilical cord blood at Vita 34 have the result that the criteria for an entry in a stem cell registry are not entirely complied with, the blood will be stored according to the selected type of contract and the data not be entered in a stem cell registry. If the umbilical cord blood is identified as being a suitable transplant for a patient and is requested by a transplantation centre, Vita 34 shall ask the legal representatives or the adult child in writing, whether the umbilical cord blood is to be released as transplant (donation) or not. If the legal representatives / adult child decide in favour of donating the umbilical cord blood, the entire preparation shall be released for transplantation. In such a case, the fees paid to Vita 34 pursuant to 5 until that time (plus the average base rate for the elapsed period of storage) shall be refunded to the legal representatives. If the legal representatives / adult child decide against the donation, the storage of the umbilical cord blood shall be continued according to the conditions as agreed and the entry in the stem cell registry deleted. 2 Obligations of Vita 34 (1) Vita 34 shall assume the following duties towards the child in connection with the collection of umbilical cord blood and umbilical cord tissue and the storage of the umbilical cord blood preparation: 1. The overall responsibility for the collection of umbilical cord blood. 2. The delivery of a collection kit. 3. The assignment of the selected birth centre or attending physician or freelance midwife (hereinafter referred to as the person collecting the umbilical cord blood) collaborating with Vita 34 in Germany with the collection of the umbilical cord blood. The assignment will also include the instruction to abstain from collecting the umbilical cord blood at one s own discretion, if this is required from a medical point of view to protect the mother s and child s health. 4. The transport of the umbilical cord blood from the birth centre to the facility of Vita The testing of the umbilical cord blood upon receipt for its suitability for preparation. 6. a) The preparation, cryo-preservation, and storage of the umbilical cord blood preparation. b) The quality control of the umbilical cord blood preparation pursuant to the legal requirements in Germany. 7. The professional release to the physician / other user after repeated testing of the umbilical cord blood preparation; free transport to any centre of application in Germany. 8. The rendering of the services included in the selected type of contract (as of 1/10/2013). In case umbilical cord tissue is stored, the items 1 to 6 and 8 shall be accordingly applicable. (2) If the tests pursuant to 2 sec. 1 no. 5 have the result that the preparation of the umbilical cord blood is impossible or not justifiable, Vita 34 shall inform the legal representatives in writing and destroy the umbilical cord blood. In case of the additional storage of umbilical cord tissue, the preparation and storage of the umbilical cord tissue shall also be effected if the umbilical cord blood has to be destroyed for the reasons given in clause 1, if there are no other opposing reasons and in particular if tissue was collected in a sufficient quantity and quality. (3) If the tests pursuant to 2 sec. 1 no. 6 b have the result that the umbilical cord blood preparation shows quality defects, but the storage can nevertheless be continued, Vita 34 shall ask the legal representatives in writing, whether the storage is to be continued despite the quality defects. If this is not the case, Vita 34 shall destroy the umbilical cord blood preparation. If Vita 34 does not 2 receive any notification in writing within four weeks, this shall be regarded as consent to the continued storage and the related fees will be invoiced pursuant to 5. Vita 34 shall herewith undertake to inform the legal representatives in this written notification according to clause 1 in particular about the fact that if they do not receive any written information on whether the storage is to be continued within four weeks, this shall be regarded as consent to the continued storage and the related fees will be invoiced pursuant to 5. In case of the additional storage of umbilical cord tissue, the storage of umbilical cord tissue pursuant to the contract shall be effected in those cases, in which the legal representatives refuse the continued storage of the umbilical cord blood for the reasons given in clause 1. (4) Vita 34 may use reliable subcontractors to fulfil its obligations. (5) In case Vita 34 becomes insolvent, a special insurance is provided to ensure the continued storage of the umbilical cord blood and/or umbilical cord tissue for 50 years from the initial storage. (6) Vita 34 guarantees a family support to the child until its 20th birthday in accordance with the related type of contract, if the umbilical cord blood stored at Vita 34 is requested by the attending physician and therapeutically applied to the child within the scope of cancer therapy (stem cell transplantation). This support shall be granted at his/her disposal irrespective of the therapy costs covered by the health insurance. However, it shall be granted only, if the fees pursuant to 5 have been paid. 3 Obligations of the mother, the legal representatives / consent (1) The mother or the legal representatives shall 1. Truthfully and thoroughly complete and sign the following forms submitted by Vita 34 and return them to Vita 34: 1) Medical history form until the birth 2) Copy of maternity card until the birth 3) Follow-up medical history form 14 days after the birth at the latest 4) Information and consent form regarding the collection of umbilical cord blood and umbilical cord tissue according to the selected type of contract 5) Declaration of consent to tissue typing pursuant to German Genetic Diagnostic Act if the VitaPlusDonation type of contract is selected. 2. Select only a birth centre collaborating with Vita 34, indicate the desired collection of umbilical cord blood and, if applicable, umbilical cord tissue again to the physician / midwife as well as hand the collection kit and the original deed of release provided by Vita 34 over to the person collecting the umbilical cord blood and, if applicable, the umbilical cord tissue immediately before the birth. 3. Promptly notify Vita 34 in writing of the name/s of the child/children after the birth. 4. Promptly notify Vita 34 of blood-borne infectious diseases of the mother or the child occurring within twelve months after the birth (e.g. hepatitis B, hepatitis C, or HIV). (2) The legal representatives shall consent to umbilical cord blood being collected after the cord of the child / children was cut. If the VitaPlusNabelschnur type of contract is selected, this consent shall apply to the collection of umbilical cord tissue as well. (3) The mother shall agree that a blood sample is taken from her to do the necessary infection-serology tests (incl. HIV) at the time of the birth (± 48 h). (4) The legal representatives shall agree that findings / data obtained by the physician / midwife / clinic during the pregnancy / birth are submitted to Vita 34. This shall apply as well to findings obtained after transplantation of umbilical cord blood and umbilical cord tissue cells. The legal representatives shall release the medical personnel from their obligation to confidentiality in this respect. The legal representatives shall agree that findings obtained by Vita 34 (except the results of the preventive screening test) are submitted by Vita 34 to the attending gynaecologist and / or physician at the clinic and that Vita 34 complies with the statutory obligations to report specific medical parameters. (5) If the contractual option of a preventive screening test is selected, the legal representatives shall agree that molecular-genetic diagnostic tests (preventive screening test) are performed with the child s umbilical cord blood in accordance with the given parameters. This consent can be revoked at any time with effect for the future. The legal representatives shall be entitled to not acknowledge the examination results or parts of such results and to have them destroyed. The legal representatives shall agree to the storage of the examination material for verification of the results; this sample shall be destroyed after ten years. The legal representatives shall furthermore agree that the laboratory submits the results of the analysis in confidence to Vita Certificate of storage (1) Vita 34 shall issue a certificate of storage after cryo-preservation and storage of the umbilical cord blood and/or umbilical cord tissue preparation as well as completion of the necessary examinations and send this certificate to the legal representatives. The certificate incorporates all the details communicated up to six weeks after the birth pursuant to 3 sec. 1, no Payment (1) Vita 34 shall receive a contract fee and an annual fee pursuant to the selected type of contract for the storage of a child s umbilical cord blood and, if applicable, umbilical cord tissue according to the current price list. The prices given in the price list shall include VAT. Vita 34 guarantees the amount of the annual fee for the first 20 years from the initial storage of the umbilical cord blood or umbilical cord tissue. As of the 21st year, Vita 34 shall reserve the right to adjust the annual fee in accordance with the officially established rate of price increase plus increased relevant taxes that have accumulated since the beginning of the storage and to make this adjustment again after the expiry of five years respectively. If the annual fee for the first 25 years or the first 50 years is paid in advance, Vita 34 shall reserve the right to adjust the annual fee as of the 26th year or the 51st year in accordance with the officially established rate of price increase plus increased relevant taxes that have accumulated since the beginning of the storage and to make this

37 Services and prices Guideline for parents adjustment again after the expiry of five years respectively. (2) All the fees imposed in accordance with the contract and which the legal representatives are jointly and severally liable for, shall be due for payment after the invoice was issued. After the contract was concluded, a downpayment on the contract fee at the amount of 195 Euro is charged for each child. After the successful storage, the invoice of the respective remainder of the contract fee is issued together with the certificate pursuant to 4 sec. 1. Vita 34 will debit the annual fee directly from the given bank account every year in advance. If payment by instalments was agreed, the total receivables shall become due for payment, once two successive instalments were not paid on schedule. (3) In case of multiple births, the full contract fee pursuant to sec. 1 will be charged for child 1 and only 50 percent of the contract fee for child 2; as of child 3 the contract fee shall be inapplicable. A down-payment of 195 Euro is invoiced for each child. The annual fee must be paid for each stored preparation. If only one umbilical cord blood preparation can be stored, the annual fee or the compact price for child 1 plus the annual fee as of the initial storage of the umbilical cord blood or as of the child s 25th birthday (VitaPlus25 or VitaPlusNabelschnur25) or as of the child s 50th birthday (VitaPlus50 or VitaPlusNabelSchnur50) will be charged. (4) If the contract fee and, if applicable and depending on the selected type of contract, the annual fee is not paid within three months after the due date despite a request for payment, Vita 34 shall be entitled to cancel the contract and to destroy the umbilical cord blood and/or umbilical cord tissue preparation with eight weeks prior notice. (5) Discounts and other benefits granted by Vita 34 (e.g. loyalty bonuses, special conditions for multiple births) cannot be combined with each other, do not apply to the down-payment and are not granted with retroactive effect. (6) If payment by instalments is required, financing by a partner bank is a possible option. The decision on the financing shall be made at the bank s sole discretion. If for any reason whatsoever the bank does not finance the contract fee, the legal representatives or Vita 34 may declare their withdrawal from the contract in writing within four weeks. Vita 34 is in that case not entitled to claim the payment of the contract fee; the down-payment, however, at the amount of 195 Euro will become due for payment, if the umbilical cord blood or the umbilical cord tissue was already stored. If the legal representatives do not withdraw from the contract after the bank s refusal, the full amount of fees shall become due for payment. If the requirements pursuant to 5 sec. 4 are complied with, Vita 34 may terminate the contract. If the storage was already completed, Vita 34 shall be entitled to destroy the umbilical cord blood or umbilical cord tissue preparation with eight weeks prior notice. 6 Contract period / cancellation / termination (1) The term of the contract shall be unlimited. (2) The legal representatives may cancel the contract in writing without stating reasons with effect of the next birthday. (3) The regular cancellation by Vita 34 shall be excluded. This shall not affect the right of extraordinary cancellation for cause of Vita 34 (e.g. default of payment pursuant to 5). (4) If the contract is cancelled by the legal representatives, neither the claim of Vita 34 for payment of the full contract fee and the annual fee already incurred until the time of the cancellation shall expire nor does a claim for refund or reimbursement of the down-payment exist. If the contract is cancelled in writing within four weeks after the birth, Vita 34 shall not receive the full contract fee, but only the down-payment at the amount of 195 Euro, unless the contract provides otherwise. If the VitaPlusNabelschnur type of contract is selected, an additional flat fee for the cancellation at the amount of 195 Euro will be demanded. (5) The contract shall be terminated automatically, without a notice of cancellation being required, if 1. Urgent medical reasons in terms of the legal regulations prevent the storage of the umbilical cord blood or umbilical cord tissue before the collection. Vita 34 shall notify the parents of this in writing. 2. The person collecting the umbilical cord blood or umbilical cord tissue refuses to execute the collection of umbilical cord blood and/or umbilical cord tissue or refrains from the collection at his/her own discretion ( 2 sec. 1 no. 3) or other reasons prevent the collection of umbilical cord blood or umbilical cord tissue. 3. The tests upon receipt of the umbilical cord blood and umbilical cord tissue pursuant to 2 sec. 1 no. 5 show that a preparation is impossible or not justifiable ( 2 sec. 2). 4. The quality control of the umbilical cord blood preparation pursuant to 2 sec. 1 no. 6 b results in quality defects and the legal representatives refuse the further storage within four weeks pursuant to 2 sec The reasons for termination pursuant to no. 4 shall not apply to the VitaPlusNabelschnur type of contract, if the preparation and storage of the umbilical cord blood was rejected by the legal representatives, but the storage of umbilical cord tissue is possible according to the quality requirements. If the legal representatives decline the storage of umbilical cord blood and the consent to the further storage of umbilical cord tissue, the amount of the contract fee for the storage of umbilical cord tissue in such a case shall comply with contract fee for the storage of umbilical cord blood minus the down-payment made at the amount of 195 Euro and, if applicable, plus the annual fee according to the selected type of contract. (6) In case the contract is terminated pursuant to sec. 5, no. 1 to 4, Vita 34 shall receive only the down-payment at the amount of 195 Euro. This shall not apply to cases as described in sec. 5, no. 4 (VitaPlusNabelschnur), to which the provisions stipulated therein shall apply. (7) If a contract of the type VitaPlusNabelschnur is cancelled, the storage of umbilical cord blood and umbilical cord tissue may be cancelled separately. The amount of the annual fee for the respectively remaining storage complies with the annual fee for the storage of umbilical cord blood. The contract fee shall not be refunded. (8) In case a contract with the option of preventive screening test is terminated pursuant to sec. 4, clause 2 or sec. 5, no. 3 or 4, an additional fee at the amount of 390 Euro, VAT included, shall be paid to Vita 34 for each child for the provided findings of the preventive screening test. This shall also apply to multiple births. (9) If the contract is terminated pursuant to sec. 2, 3, 4, 5, and/or 7, the legal representatives shall agree that Vita 34 destroys the umbilical cord blood and/or umbilical cord tissue, unless the child disposes of the umbilical cord blood and/or umbilical cord tissue within eight weeks after the contract has ended pursuant to 48 German Medical Preparations Act. (10) Apart from the above stipulations, the contract shall terminate and thus the obligation to pay the annual fees, if Vita 34 submits the stored umbilical cord blood preparation to the attending physician upon his/her request. If the VitaPlusNabelschnur type of contract was selected and only the umbilical cord blood preparation was released, the annual fee for the continued storage of the umbilical cord tissue preparation shall comply with section 7 as above. 7 Assignment of claims The legal representatives shall agree that Vita 34 may assign all outstanding claims against them in whole or in parts and disclose the data required for this purpose as well as submit the required documents. The information and documents will be treated as strictly confidential and not abused. 8 Liability of Vita 34 / waiver of claims against the clinic (1) Vita 34 shall be liable for the object of the contract as given in 1 clause 1 in accordance with the legal regulations. (2) Vita 34 shall not assume any liability whatsoever for current or possible future applications of the umbilical cord blood or umbilical cord tissue preparation, which are not the object of the contract in accordance with 1 clause 2. (3) On their own behalf and in the name of the child, the legal representatives shall waive any claims against the birth centre or the person collecting the umbilical cord blood and/or the umbilical cord tissue and the maternal blood, unless such claims are based on deliberate intention. For this purpose, they submit the signed original deed of release to the birth centre. This deed shall not affect any claims of the child against Vita 34 due to negligence of the person collecting the umbilical cord blood. 9 Data protection (1) Vita 34 shall be authorised to store the personal data of the child and the legal representatives that are necessary to implement the contract and to pass them on to contractual partners where required to implement the contract. Vita 34 shall treat these data as confidential and commit its contractual partners to confidentiality. (2) Vita 34 shall be authorised to pass the data which are necessary to apply the umbilical cord blood for therapeutic purposes to the physician / other user upon request. 10 Final provisions (1) The parties shall notify each other promptly in writing of changes of address or name. The legal representatives shall furthermore notify Vita 34 promptly of changes in the representation relationships. This shall include the notification of the child s new address details when he/she reaches the legal age. (2) The assignment of this contract or of obligations or rights resulting from this contract by Vita 34 to a third party shall require the written consent of the legal representatives, unless an affiliated company of Vita 34 in terms of 15 German Stock Companies Act is concerned. (3) Any changes or supplements to this contract must be made in writing. This shall also apply to the requirement of written form itself. (4) Should a provision of this contract be invalid or impracticable, this shall not affect the validity of the remaining provisions. The parties shall undertake to replace the invalid or impracticable provision by such a valid and practicable provision that comes closest to the originally intended purpose of the invalid or impracticable provision. The same shall apply to contractual gaps. (5) The laws of Germany shall be applicable. Information on the Right of revocation You may revoke your declaration of agreement in writing (e.g. letter, fax, ) without stating any reasons within four weeks. The period begins with the receipt of this information in text form, though not before the contract is concluded / the confirmation of order was received and not before we have complied with our obligation to inform pursuant to article in connection with 1 sec. 1, 2 Introductory Act to German Commercial Code. To keep the revocation period, it shall be sufficient to send the notice of revocation in time to: Vita 34 AG, Perlickstrasse 5, D Leipzig; by fax to: +49 (0) , or by to: kundenbetreuung@vita34.de. Consequences of revocation In case of an effective revocation performance received by both parties is to be returned. If you cannot return the collection kit or only return it in open condition, Vita 34 shall receive the down-payment at the amount of 195 Euro. The collection kit must be returned at our expense and risk. Obligations to refund payments shall be complied with within 30 days. This period for you shall start with the date of sending the revocation, for us with the date of the receipt of the revocation. Special note Your right of revocation shall expire prematurely, if the contract is fully performed by both parties at your express request, before you exercise your right of revocation. End of information on right of revocation as of 1/10/