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

Transcription

1 Melina (8 years), Happy stem cell customer Guidebook for parents Information on the storage of umbilical cord blood and umbilical cord tissue secure first-class innovative

2 CONTENT STEM CELLS VIABLE ALL-ROUNDERS 3 UMBILICAL CORD BLOOD AND TISSUE 5 SETUP OF A STEM CELL UNIT A SPECIAL DECISION 6 VITA 34 THE LARGEST STEM CELL BANK IN THE GERMAN-SPEAKING COUNTRIES 7 HOW THE UMBILICAL CORD BECOMES A STEM CELL UNIT 9 SERVICES AND PRICES 11 PRIZE OVERVIEW: UMBILICAL CORD BLOOD 12 PRIZE OVERVIEW: UMBILICAL CORD BLOOD & -TISSUE 13 THE VITA 34 SERVICE PROMISES 14 PREVENTIVE SCREENING TEST: EARLY RECOGNITION OF HEALTH RISKS 15 SIBLING INITIATIVE: HELP FOR SICK SIBLINGS 16 OUR BABY: YOUR COMPANION THROUGH PREGNANCY 17

3 STEM CELLS VIABLE ALL-ROUNDERS Stem cells Muscle cells Blood cells Skin cells Bone cells Cartilage cells Nerve cells Cells of vascular walls Liver cells Myocardial cells Stem cells are the building blocks of life. An entire human being develops from the initial stem cell - the fertilised egg. Through reproduction and differentiation, they form over 200 different cell types: e.g. blood, muscle, or nerve cells. And even after the birth, stem cells make us grow further. They are also responsible for regeneration and the repair of injuries and diseases. Thus, they accompany us our whole lives. However, stem cells age as we do! Young stem cells are always the most powerful. That is why fractures and wounds of children heal so much faster than in older people the viability of the stem cells subsides. Other than stem cells that are collected later (e.g. from bone marrow), their DNA is not damaged yet. Recent examinations show that certain age-related diseases like arteriosclerosis occur only, when the stem cells have become too old to repair the damage themselves. Hence, bone marrow donors under 45 years are preferred, as our self-healing powers fade the older we get. Therefore, it is important to secure the stem cells at an early stage. The best option for this is at birth. 3

4 Stem cells from the umbilical cord a unique chance In the last third of the pregnancy, the stem cells start to migrate; they let themselves drift with the blood stream into the bone marrow. This last migration is also the reason, why so many viable stem cells are contained in the blood circulation of the unborn child. The umbilical cord therefore contains millions of usually virus-free stem cells. They can be collected easily at birth without causing pain and are, other than embryonic stem cells, ethically unobjectionable. Due to their high development potential, they can become a variety of cell types. All new blood cells, the body s natural immune system as well as other organ tissues can develop out of stem cells contained in umbilical cord. They can be collected easily at birth without causing pain and are, other than embryonic stem cells, ethically unobjectionable. 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. Advantages of stem cells from the umbilical cord Their collection is painless and completely safe for mother and child. They are unpolluted, able to divide, more viable and usually virus-free. Very short waiting time: Umbilical cord blood is available within a couple of days - and even faster in emergencies. Use the full potential of the umbilical cord with Vita 34 Vita 34 is the only German stem cell bank that enables parents to access several stem cell sources from the umbilical cord. Not only stem cells from umbilical cord blood can be secured, but in many hospitals also those from the umbilical cord tissue. This enhances the potential for possible applications considerably. 4

5 UMBILICAL CORD BLOOD AND TISSUE COMBINED STEM CELL POWER Stem cells from umbilical cord BLOOD The collection of umbilical cord blood is easy and safe for mother and child. The parents seldom notice anything about the collection by trained obstetricians. The umbilical cord is cut and then punctured to collect the remaining blood from the placenta and the umbilical cord. The collected blood is rich in blood stem cells and contains stem cells for connective tissue, blood vessels, and other less researched components. Clear and brief: cord blood is rich in blood stem cells, cord blood is already applied after chemotherapies as standard, and cord blood can be stored for decades. Stem cells from umbilical cord TISSUE The concentration of mesenchymal stem cells (MSC) is particularly high in umbilical cord tissue. They have a great differentiation potential and can thus develop into various tissues. MSCs are precursor cells, which can develop to become a variety of cell types, e.g. connective tissue, cartilage, muscle, and tendons can be made of them. Vita 34 is the only organization in Germany that has the license to store umbilical cord tissue to extract stem cells for therapeutic purposes later. The whole potential of the umbilical cord can thus be tapped optimally. Clear and brief: cord tissue is rich in mesenchymal stem cells (precursor cells of connective and cartilage tissue), cord tissue is applied in regenerative medicine, and cord tissue can be stored in Germany with Vita 34 only. Is your clinic part of it? Give us a call. 5

6 SETUP OF A STEM CELL DEPOSIT A SPECIAL DECISION We are convinced that a stem cell deposit containing umbilical cord blood and tissue becomes more valuable every year. Because research progresses. The great potential of stem cells is seen increasingly in applications concerning the regeneration of tissue and cells, where viability and prompt availability play an important role. More and more possible applications of stem cells Scientists expect further insight and development in the field of stem cell therapy in the next years. Vita 34 works on other possible applications as well. In collaboration with renowned universities and research institutions, we investigate new therapeutic options in case of stroke, heart attack, diseases of the hematopoietic system, and diabetes type 1. Stem cell preparations stored with Vita 34 were successfully applied in individual cases, treatment attempts, and studies. Umbilical cord was applied e.g. in the treatment of juvenile diabetes, infantile brain damage as well as hematopoietic disorders (aplastic anaemia), the correction and regeneration of the immune system and the stimulation of haematosis after chemotherapies. Important licenses for later applications The storage and application of stem cells from umbilical cord blood and tissue are licensed by the Federal Ministry of Health under strict conditions. Vita 34 supports the extensive application of stem cells. Possible applications of Vita 34 stem cell preparations are therefore broader than those of most private stem cell banks. A Vita 34 stem cell deposit can be applied for: your child, its siblings, other relatives 6

7 VITA 34 THE LARGEST STEM CELL BANK IN THE GERMAN-SPEAKING COUNTRIES Vita 34 has been storing umbilical cord blood since 1997 and for this reason is the largest and most experienced stem cell bank in the German-speaking countries. Our application practice, research and innovations set standards and make Vita 34 a specialist in stem cell storage. Vita means life. The number 34 stands for the cell-surface molecule CD34, which 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 private stem cell bank in Europe. It is furthermore the largest one in Germany and Austria. Vita 34 stands out due to a highly qualified team of specialised physicians, chemists, biologists, and biotechnologists. About 140,000 stem cell deposits from Germany and other European countries have been stored with the specialist. Wide network of clinics Vita 34 wants to provide the private stem cell storage for many parents-to-be for their children and therefore maintains a wide network with birth centres in Germany, Austria, and Switzerland. In Germany alone, Vita 34 collaborates with 95 percent of the birth centres. To the network of clinics Pioneer work for the security of 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. Vita 34 did pioneer work with its own research projects, material developments, and process optimisations - experience that benefits you. 7

8 Guaranteed quality 59 % units from other stem cell banks 59 % 41 % 41 % units from Vita % for the regeneration of haematopoiesis Applications of umbilical cord blood in Europe 33 % in the therapy of brain damage (treatment attempts with autologous umbilical cord blood) 23 % in the treatment of diabetes type 1 (clinical study) Almost half of the applications registered with Cord Blood Europe* were performed using units stored at (as of January 2016) Vita 34. Technical knowledge and experience in the application of stem cell units make Vita 34 the expert and competent partner for stem cell storage. This is the quality we guarantee. 1. Guaranteed quality** Certified manufacturing quality in compliance with Good Manufacturing Practice Safe application of umbilical cord blood 2. Guaranteed storage 50 years minimum because of a real insolvency insurance 3. Guaranteed transport From the collection at the hospital into the cryo-tank within 48 hours 4. Guaranteed price No increase of annual fee within the next 20 years * European Association of family cord blood banks ** By already 30 releases of cord blood for application, Vita 34 was able to confirm the quality of the stem cell preparations. Previous transplantations: Germany 23; Austria 2; USA 2; Spain 2 Argentina 1 8

9 HOW UMBILICAL CORD BECOMES A STEM CELL DEPOSIT The collection and storage of umbilical cord blood and tissue carries great opportunities. Moreover, the effort for you and your child is only minimal and safe. Excellent preparation and cryo-preservation creates the source material for a stem cell unit complying with pharmaceutical quality standards. 1. Decision After you assigned Vita 34 to secure your child s stem cells, we send you the collection kit, which will be opened by the doctors or the midwife at the clinic. 2. Birth and collection After the umbilical cord was cut, the personnel trained by Vita 34 collects the umbilical cord blood and the umbilical cord in a professional procedure that is free of pain and without risk for mother and child. The clinic staff informs us as soon as blood and, if applicable, tissue were collected successfully. Our reliable courier service transports the package to Leipzig. 3. 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 enclosed documents, and temperature measurement are performed. All work steps are documented in detail. 4. 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 birth, birth centre etc. The assignment of an ID number enables the clear allocation of test results, preparation, and child. 9 to step 5 to 8

10 HOW UMBILICAL CORD BECOMES A STEM CELL DEPOSIT back to step 1 to 4 5. 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 temperatures. Small samples of blood and tissue are retained for required tests. 6. 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. After the successful storage, we will send you a certificate. After the comprehensive tests are completed, you will be informed about the findings and the important details of your child s stem cell deposit in writing. 7. 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 cryo-preserved umbilical cord blood and tissue can be quickly procured and prepared for application. 8. 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. 10

11 SERVICES AND PRICES Make use of the possibility to store your child s stem cells - it is a unique opportunity. 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. Separating stem cells from blood prior to storage may lead to an 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. Comprehensive insurances even in case of application As the storage of umbilical cord blood and tissue is forward-looking, Vita 34 has secured the stem cell storage completely. We guarantee the professional storage of the stem cell preparations for decades in collaboration with leading insurance companies, even in case of insolvency of Vita 34 - and that for a period of 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 the improbable case of insolvency. A special feature of the liability insurance is that it does not only cover the employees activities, but also the collection of umbilical cord blood and tissue at the birth centre. Mobile Vita 34 stem cell team facilitates the treatment in every German hospital Stem cell therapies take place more and more beyond the established bone marrow transplantation institutions of university hospitals. Vita 34 makes a great effort to store the individual stem cell deposits in compliance with the requirements of pharmaceutical legislation. It is thus only a logical decision to implement these high quality requirements in the transport of the stem cells to the treatment centre and the processing on location as well. Vita 34 established a mobile stem cell team, which is unique all over Europe, already in Their special equipment ensures the professional provision of the preparations at hospitals and makes Vita 34 the first to contact when it comes to the application of stem cell transplants. 11

12 PRIZE OVERVIEW: UMBILICAL CORD BLOOD to umbilical cord blood and -tissue VitaPlus Non-recurring: Annual fee: 3,100 CHF 60 CHF Save 605 CHF* VitaPlus25 Advance payment for 25 years Package price: Annual fee as of age 26: 3,995 CHF 60 CHF Save 905 CHF* VitaPlus50 Advance payment for 50 years Package price: Annual fee as of age 51: 5,195 CHF 60 CHF Preventive screening test DNA testing for health risks: 480 CHF *Savings in comparison to the annual payment for Vita Plus. 12

13 PRIZE OVERVIEW: UMBILICAL CORD BLOOD & -TISSUE back to umbilical cord blood VitaPlusCord Non-recurring: Annual fee: 3,600 CHF 90 CHF Save 1,355 CHF* VitaPlusCord25 Advance payment for 25 years Package price: Annual fee as of age 26: 4,495 CHF 90 CHF Save 2,250 CHF* VitaPlusCord50 Advance payment for 50 years Package price: Annual fee as of age 51: 5,850 CHF 90 CHF Preventive screening test DNA testing for health risks: 480 CHF Special conditions for twins and multiple births: The price reduces by 50 percent for the second child. The storage is exempt from charges as of the third child. *Savings in comparison to the annual payment for VitaPlusCord. 13

14 THE VITA 34 SERVICE PROMISES Securing stem cells is good, applying them is even better. That is why you should rely on quality, experience, official licenses to release umbilical cord blood preparations, and expertise. Extensive licenses for the release of the stem cell unit Expert counselling by medical experts Detailed anamnesis and evaluation by our physicians Temperature-protected collection package containing the Vita 34 collection kit Transport through specialised courier 365 days a year Preparation in clean room (GMP standard) Quality tests in compliance with official requirements Computer-controlled cryo-preservation in Vita 34 freezing bags Collection of stem cells by trained personnel Real insolvency insurance over 50 years Further included services: Unlimited contract period Fixed annual fee for storage for the next 20 years Guaranteed price for five years and at least 150 Euro loyalty bonus for another stem cell deposit Special conditions for multiple births (e.g. twins or triplets) Express service: If you need the collection package quickly Family support of 7,000 Euro in case of stem cell application Transport of stem cells from umbilical cord to treatment centre GMP GOOD MANUFACTURING PRACTICE 14

15 PREVENTIVE SCREENING TEST: EARLY RECOGNITION OF HEALTH RISKS Preventive screening test of DNA in umbilical cord blood Even small children may suffer from intolerances, for instance to cereal flour or lactose. If undiagnosed, this may cause complaints. A preventive screening test finds out whether your child is part of the risk group. If this is the case, the paediatrician may give suitable dietary tips and recommend precautionary measures. The preventive screening tests include DNA testing for: Drug-induced hearing loss (antibiotics intolerance) AAT deficiency (dysfunction of immune system) Hemochromatosis (iron overload disease) Lactose intolerance Gluten intolerance (cereal flour intolerance) Preventive screening test this is how it works If you order the preventive screening test together with the umbilical cord blood storage, no further action is required we perform the analysis automatically. If you want to have the tests done later, we will send you material to take a saliva sample. Afterwards, we will send you the test results including detailed explanations of the findings. 15

16 SIBLING INITIATIVE: HELP FOR SICK BROTHERS AND SISTERS Because siblings may help each other with their umbilical cord blood, we created the Sibling Initiative in 2002 for families with a diseased child, who may be helped with stem cells from the umbilical cord blood of the brother or sister. If a sibling is born in this family, we store the newborn s umbilical cord blood free of charge for five years. We just need a certificate by the doctor in attendance of the diseased child indicating that the treatment with stem cells from the umbilical cord blood of the expected sibling is a therapeutic option. Umbilical cord blood stored at Vita 34 was been applied several times, for instance in a five-year old boy with aplastic anaemia, a boy suffering from leukaemia (ALL) as well as a ten-year old girl and 14-year old boy with beta thalassemia. 16

17 OUR BABY : YOUR COMPANION THROUGH PREGNANCY Share your experiences during pregnancy - with the new Vita 34 app How can you record the beautiful moments of pregnancy? Which are the best home remedies against abdominal fullness? What does the baby in my tummy look like now? Which name to choose? The new Vita 34 app addresses all these questions. The special feature: The app shares all entries, appointments, and pictures with your partner, so that the daddy-to-be is informed about every kick in mommy s belly or the next ultrasound appointment from the start. New tips, advice, and name suggestions every day Appointments for preventive medical check-ups Diary with many functions 3-D animations for every week of pregnancy Share pictures, texts, appointments, and names with your partner or via Facebook Our Baby is a valuable aid to support you in managing appointments, checklists, information, and in documenting your pregnancy. The Vita 34 app can be used intuitively and provides you with many information around the pregnancy: a combination of diary, personal organizer, tips, and having fun being pregnant. Enter the baby s calculated date of birth and the app will accompany you for the next 40 weeks, providing you with helpful tips, checklists, name suggestions every day and reminding you of preventive medical check-ups. You can even exchange data with your partner irrespective of the type of device. DOWNLOAD Download the app here and start! 17

18 Call us to get information in time: Germany: Phone: (free of charge) Vita 34 AG Headquarters: Deutscher Platz 5a Leipzig Postal address: Perlickstraße Leipzig Phone: (free of charge) or +49 (0) Fax: +49 (0) contact@vita34.com / vita34 Or take part in one of our Information sessions. Switzerland as of: 1/2016 secure first-class innovative