Some decisions. can last a. lifetime. Your guide to preserving your baby s stem cells. Europe s biggest stem cell bank. 225,000 samples stored!

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1 Some decisions can last a lifetime Your guide to preserving your baby s stem cells Europe s biggest stem cell bank 225,000 samples stored!

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3 Becoming a parent is a lifetime responsibility Having a baby is one of the most emotional and fascinating moments in life. You may start asking yourself many questions about the future of your family. You may wonder how to provide the best for your child and how to ensure its health for the years ahead. Some of the recent medical innovations can offer new possibilities to address previously unmet medical needs. At Cryo-Save, we have the passion and knowledge to assist you by offering the possibility to store your baby s stem cells from umbilical cord tissue and cord blood. This brochure was created to help you make an informed choice. You will find information on stem cells, including why they are so unique and full of potential. We will also explain the process of preserving stem cells, from both the umbilical cord and cord blood, for current and future treatments. Over 225,000 samples have been stored; confirming the confidence families have for Cryo-Save. 3

4 Stem cells: more than a simple cell The human body consists of more than 200 types of mature cells. Whether it s the heart muscle cells that beat rhythmically or red blood cells that deliver oxygen to every part of our body, all cells have a unique role to play. Stem cells are different but no less crucial: 1 They can multiply 2 They can specialise to perform specific functions 3 They can create new tissue when they divide and differentiate Stem cells are precious because they have the ability to develop into different kinds of cells within the human body. This unique process of specialisation is what builds our complex organism. Some of these stem cells remain in our body as a reserve and play a key role in regeneration in the case of damaged or aged tissue. Connect with our customer service

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6 Stem cells: life s building blocks Stem cells can be categorised according to their origin and type of functional cells produced1. At Cryo-Save, we preserve adult stem cells which are found in the bodies of both adults and children. Among them are haematopoietic stem cells (HSCs) and mesenchymal stem cells (MSCs), the two most commonly researched adult stem cells. HSCs produce all the blood and immune system cells and were first identified in bone marrow. MSCs are found in many parts of the body including bone marrow, muscle, bone, fat and other organs. These important adult stem cells, in their best shape, can be found in the umbilical cord blood and cord tissue. They have the greatest and most effective ability to produce different human tissues. The cord blood and cord tissue collection can be obtained with ease and with no risk to mother and child. They are cryo-preserved to maintain maximum viability and functionality. Scientific studies have shown that the tissue surrounding the three blood vessels in the umbilical cord (connecting the foetus to the mother) contain important, excellent quality stem cells. The substance called Wharton s Jelly is a rich source of mesenchymal stem cells which are responsible for the formation of bone, cartilage and other types of connective tissue cells in our bodies2. Cryo-Save has developed the technology to preserve the cord blood and cord tissue with the purpose to use this rich source of stem cells in medical therapy. 6 Umbilical vein Umbilical artery Wharton s jelly

7 Umbilical cord and cord blood stem cells have unique properties: At a maximum of nine months old, they have not yet suffered from the ageing process and have the potential to divide and differentiate in to specific functions better and quicker than other adult stem cells They are less likely to cause complications in allogeneic transplants (from a donor to a patient) than other adult stem cells Protected by the mother s womb from many of the viruses and infections in the open world, they are less likely to be contaminated or affected by diseases Umbilical cord blood stem cells Umbilical cord tissue stem cells And more specifically, umbilical cord derived stem cells have the unique ability to: Home in on site of injury and assist in repair when injected intravenously Transform into numerous cells, including fat, cartilage, muscle, bone and nerve tissue Exhibit anti-inflammatory and immunesuppressant characteristics; an important application in auto-immune disorders and inflammatory stages of numerous diseases 7

8 Cord blood stem cells in medical practice: the current trends The current applications of stem cells aim at restoring the bone marrow following chemo- and/or radiotherapy by the result of which, unfortunately, not only the cancerous cells but also healthy cells are often diminished. The transplantation of stem cells in the human body is expected to help in regeneration. Such transplants were traditionally performed with stem cells harvested from the bone marrow of a donor, but expert scientists see cord blood derived stem cells to be an excellent alternative for such purposes. The first successful umbilical cord blood derived stem cell transplant was performed in France in 1988 for a five-year-old boy suffering from a rare genetic disorder called Fanconi s Anemia 3. The donor was his sister and her cord blood was collected at birth and used in the transplantation. Today, the patient is healthy and cured of the disease. Stem cell transplants are increasing among paediatric patients and have risen steadily since ,200 1, Transplants in children (younger than 18 years of age), registered by National Marrow Donor Program in 2011 More than 70 diseases are treated with stem cells More than 70 diseases are treated with stem cells. Leukaemia shows the highest percentage of treatment via stem cell transplant. Overview of the transplants recorded by Eurocord in children, presented by diagnosis, 2011 Acute Leukaemina, 47% Blood related disorders, 10% Lymphomas / solid tumors, 2% Bone marrow failure, 11% Hemoglobinopathy, 7% Immune Deficiency, 11% Metabolic Disorders, 9% Histiocytosis / others, 3% 8

9 Cord blood use has especially increased among paediatric patients since Half of the transplants in children in 2011 used cord blood stem cells: 1,200 1, Bone Marrow Peripheral Blood Stem Cells Cord Blood Transplants in children (younger than 18 years of age) by cell source, registered by National Marrow Donor Program in

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11 Use of stem cells in transplantation Talk to an expert! One of the most difficult tasks in transplantation is finding a matching donor. There are two options to transplant stem cells: Allogeneic transplant: when patients receive cells that have been donated by someone else. They must be tested for compatibility before their use and sometimes additional treatments are needed to avoid rejections by the body. Even then, a perfect match is no guarantee. Autologous transplant: when patients receive cells from their own body. This kind of transplant is 100% compatible with the owner and, depending on the disease, can be the preferred option for transplants. Stem cells from a relative (preferably a sibling) are generally the first option of a transplant when considering the source of stem cells. A large part of allogeneic transplants use stem cells from a family member. Family banking opens up opportunities for family members: When compared to bone marrow stem cells, umbilical cord blood stem cells have less strict HLA matching requirements making these cells more likely to match a family member. Banking your child s cord blood stem cells is valuable for the child itself, but also increases the possibility of having transplantable stem cells for a family member in medical need. 1 2 If you decide to save your child s stem cells, his or her siblings could benefit from a perfect HLA match. There is a 25% chance that any given sibling pair would be HLA-identical by inheritance, hence, acceptable as a donor 4. In addition, cord blood does not have to be matched as precisely as stem cells from bone marrow. A bone marrow transplant requires a donor-patient match of 100% (6 of the 6 major tissue alleles need to be matched). However cord blood transplants can have a donor-patient match of 4 of the 6 major tissue alleles, that is to say a 40% chance of use 4. 11

12 What the future holds: expert opinions Beyond the currently approved applications of cord blood transplants, clinical trials are under way to improve results and to develop new applications. Clinical trials analyse new medical treatments for their safety, efficacy and potentially adverse effects in humans. The ClinicalTrials.gov website is a registry containing most of the current clinical trials, conducted in public or private. It lists over 4,000 trials involving stem cells with over 200 of these trials using umbilical cord blood stem cells 5. Dr. Marcin Jurga, R&D Manager at Cryo-Save s flagship lab, Niel, Belgium: Apart from current therapies using hematopoietic stem cells from cord blood, there is an increasing number of clinical trials using mesenchymal stem cells for treatment of non-hematopoietic diseases, like orthopedic applications, graft-versus-host disease, heart diseases, liver diseases, diabetes, neurology and many others. These cells are also used in tissue engineering applications where artificial organs are built in a laboratory to replace damaged tissues after transplantation. Results from these trials and preclinical research will allow for more effective stem cell therapies in the future. Dr. Luis Madero, Director of Oncohematology, Niño Jesús Hospital, Madrid, Spain: There are clinical trials for the use of cord blood cells for non-hematopoietic diseases in children for cases of cerebral palsy and diabetes. The information reported on the cerebral palsy trials has given some positive preliminary results. The experience in diabetes is still limited and more data need to be gathered before any conclusion can be drawn. Prof. Dr. Daniel Surbek, Department of Obstetrics and Gynecology, Inselspital Bern, Switzerland: Evidence from recent studies suggests that transplantation of stem cells from the umbilical cord may be used as treatment for severe perinatal brain damage due to preterm delivery or birth asphyxia. Transplanted stem cells may regenerate damaged neural tissue and central nervous system function. Several clinical trials in children affected by cerebral palsy are ongoing. Dr. Csaba Papp, associate professor, medical geneticist, Semmelweis University, Budapest, Hungary: Together with the umbilical cord blood, the preservation of the cord tissue is not only a possibility for obtaining mesenchymal stem cells, but for yielding other cells that are important for future stem cell therapies. 12

13 Read about the latest stem cell treatments: 13

14 Reasons to save your baby s stem cells Stem cell storage from a newborn s umbilical cord and cord blood is increasing among families. Cryo-Save Group offers family storage for the following reasons: Autologous matching is guaranteed The siblings could benefit from the same sample: they have a one-in-four chance for a perfect match and even more when considering transplantation using partially mismatched donors The sample is immediately available The sample remains the property of the child under the guardianship of the parents Umbilical cord blood is an accepted source of stem cells that has already been used to treat essentially all malignant and nonmalignant diseases that can be treated by bone marrow (BM) transplantation 6 The mesenchymal stem cells found in the cord tissue are promising in the field of cell therapy and tissue regeneration Stem cells are too valuable to be wasted. Nowadays, an estimated 90% to 95% of cord blood is discarded after birth. Cryo-Save is convinced that the cord blood and cord tissue should be saved, either with a family bank or made available for public use or research. We firmly believe that these important cells should not be discarded. 14

15 Find out why other parents have stored 15

16 We care about families and children. Cryo-Save is constantly striving to improve our services and to offer the best possible guidance to our customers, the medical community and the public in general. Thanks to our corporate social responsibility programme, we encourage all our offices to take actions that have a positive impact on their local community. With our Cost Free Donation Program we offer free of cost storage to families wishing to store their newborn s umbilical cord blood stem cells for a family member diagnosed with a life-threatening disease treatable by stem cells. In addition, Cryo-Save launched the Board of Parents in This programme gives parents the opportunity to visit a Cryo-Save lab and learn more about our family stem cell bank. This is a unique initiative to create interactions between the company and its customers and a way to reinforce the transparency of the organization. 16

17 Discover who we are and why we care With more than 225,000 samples preserved, Cryo-Save is the leading family stem cell bank in Europe. We are accredited as a Licensed Organ & Tissue Establishment for the collection, analysis, processing and preservation of stem cells from umbilical cord blood and cord tissue. Established in 2000, Cryo-Save has been active in the stem cell industry for more than 12 years. Our long-established professionalism and expertise is recognised by the medical community and we have cryo-preserved samples from over 40 countries on three continents. Choosing Cryo-Save means: Quality: We guarantee the highest quality standards in terms of transport, processing and security of your baby s stored stem cells. Several Cryo-Save samples have been successfully used in stem cell transplantations. Professional expertise: With more than 12 years of cryopreservation activity, over 20 medical doctors and 40 lab technicians, we are the most experienced stem cell bank in Europe. Dual storage: We use a dual storage system, meaning that the stem cells are stored independently in two separate storage tanks for additional safety. Research: Cryo-Save supports high-level research and collaborates with leading universities, physicians and stem cell scientists. Transparency: Cryo-Save regularly invites parents and health care professionals to visit the lab and storage facilities in Belgium. Accreditations: Cryo-Save is a Licensed Organ & Tissue Establishment as by the Dutch Ministry of Health s Farmatec, carries a Tissue Bank Accreditation from the Ministry of Public Health, Welfare and Sports, and holds a Certificate of Product Liability. Cryo-Save s laboratories are accredited by the following: FAMHP (Belgium), WHO GMP (Belgium, India), ISO 9001:2008 (Belgium, India), AABB (Belgium process pending, Dubai, India, South Africa process pending), and FDA registered (Dubai). Get to know us better! 17

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19 Cryo-Save, state-of-the-art processing and storage facilities Cryo-Save uses state-of-the-art processing and storage facilities in Belgium, Germany, Dubai, India and South Africa. We endeavour to ensure that all our facilities meet the highest quality standards and are properly accredited. All Cryo-Save laboratories are obliged to reach or exceed nationally and internationally imposed legal standards. By choosing Cryo-Save to store your child s stem cells, you make a secure and safe choice. For more information about our labs, we invite you to visit our labs website at Process and storage expertise The complete process, from collection of the sample through to the transportation, processing, testing, freezing, storage and release for therapy, is highly monitored and controlled. The Cryo-Save Quality Management System is structured according to ISO 9001, AABB, WHO GMP with FACT certification (from June 2014). Cryo-Save uses special state-of-the-art techniques to ensure full traceability from the client through to the laboratory and storage facilities. Stem cell collection at birth Specially designed collection kit Registration of the sample at the lab Examination and preparation of the sample Storage of the sample We process all samples using a fully automated system with no risk of contamination. This volume reduction of umbilical cord blood before cryopreservation is the preferred method applied for most public and family cord blood banks worldwide. For hematopoietic stem cell transplantations, only the white blood cells are required and represent the main therapeutic potential. The automated processing technique also preserves the highly immature stem cells with potential application for treatment of non-hematopoietic diseases. Cryo-Save stores samples from over 70 countries: Abu Dhabi Albania Andorra Angola Australia Austria Bahrain Belgium Bosnia-Herzegovina Botswana Brazil Bulgaria Canada Croatia Cyprus Czech Republic Denmark Estonia Egypt Finland Germany Greece Hong Kong, China Hungary India Iran Ireland Israel Italy Japan Kenya Kosovo Kuwait Latvia Lebanon Liechtenstein Luxemburg Libya Macedonia Malta Mauritius Monaco Montenegro Mozambique Namibia The Netherlands New Zealand Nigeria Norway Oman Pakistan Poland Portugal Qatar Romania Russia Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey UAE USA UK Zambia Zimbabwe 19

20 Steps to store your child s stem cells Contact us for personal care. Once you have decided to store your child s stem cells with Cryo-Save, please complete the documents included in the information package and return them to us. Consult the hospital or clinic where you plan to give birth about the cord blood and/or cord tissue collection. Remember that the earlier you decide, the more time you will have to collect the right information about the procedure. Before delivery, you will receive our collection kit enabling your physician or midwife to collect the umbilical cord blood and/or cord tissue. Be sure to take it with you to the delivery clinic and inform the medical staff of the desired collection. Immediately after birth, the sample will be picked up by a certified international courier service and taken to our processing facility. The sample must arrive to our laboratory within 48 hours. Sample processing and storage. In our laboratory, the sample will be processed, examined and prepared for storage. A certificate will be issued with a unique number corresponding to your baby s stem cells. Remember that the collection of the umbilical cord blood and/or cord tissue is a non-invasive and risk-free collection procedure. It s easy, takes only a few minutes and is completely harmless to both the mother and child. The collection does not interfere with the normal delivery process. Please visit our website to find the customer service operator closest to you: For regular updates, follow us on our social media platforms! Call now to secure your baby s future

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22 Frequently asked questions Because details are important Is it worth it to save my baby s stem cells? Hematopoietic stem cells (HSCs) are currently used to treat more than 70 blood and blood-related diseases. Mesenchymal stem cells (MSCs) have been implicated in regenerative medicine, with the end goal to replace, repair or regenerate living functional cells or tissues. Stem cells are actively being researched for the treatment of numerous diseases, like cerebral palsy, type 1 diabetes, brain disorders, heart conditions, auto-immune disorders, liver disorders, neurological diseases and others. Why should I save my baby s umbilical cord blood stem cells if there are alternatives to cord blood banking? There are other alternatives to cord blood banking, such as stem cells collected from bone marrow and by peripheral blood. However, stem cells from the umbilical cord blood have numerous advantages: they are the youngest and most effective stem cells that can be found in the human body and relatively unaffected by diseases; the procedure to collect them is non-invasive and they are immediately available. Can my baby s stem cells also be used for another family member? Your baby s stem cells can be used for anyone having a genetic match, such as a brother or sister. Stem cells from a relative (preferably a sibling) are generally the first option of a transplant when considering the source of stem cells. A large part of allogeneic transplants use stem cells from a family member. What are an individual s chances of using cord blood before the age of 20 years? At present, the odds that a person will have a stem cell transplant for blood or blood related disorder, either from their own cells or from a donor before age 20 are about 1 in 1700, whereas by age 70 the odds are 1 in 200. However, this data does not reflect potential therapies using stem cells that may be developed in the future 7. Can the delivery of the baby be altered or delayed to successfully collect the cord blood? Cord blood collection does not interfere with the birthing process or change the way that the obstetrician delivers the child. Could someone s own cells be used in conditions where the disease has a genetic origin? If the child has a genetic disease, such as sickle cell anaemia, the stem cells will have the same genetic defect. In cases in which autologous (one s own) stem cells cannot be used, a sibling s cord blood is the next best option. Do you still have a question? Please call us at or visit our website to find out more! 22

23 References: 1 Stem Cell Basics. Stem Cell Information. The National Institute of Health. Web. 28 Sept < basics1.asp> 2 Sarugaser R., et al. Human umbilical cord perivascular (HUCPV) cells: a source of mesenchymal progenitors. Stem Cells 23:2 (2005): Print. 3 Gluckman, E., et al. Hematopoietic reconstitution in a patient with Fanconi s anemia by means of umbilical-cord blood from an HLAidentical sibling. N Engl J Med (1989): Print. 4 Beatty, P. G., et al. Probability of finding HLA-mismatched related or unrelated marrow or cord blood donors. Human Immunology 61.8 (2000): Print. 5 Search for Studies search term stem cells. ClinicalTrials.gov. Web. 28 Sept < 6 Broxmeyer, H. E. Enhancing engraftment of cord blood cells via insight into the biology of stem/progenitor cell function. Annals of the New York Academy of Sciences 1266 (2012): Print. 7 Nietfeld, J. J., et al. Lifetime probabilities of hematopoietic stem cell transplantation in the US. Biol Blood Marrow Transplant 14.3 (2008): Print.

24 Cryo-Save AG Churerstrasse 65 B 8808 Pfäffikon SZ Switzerland Office Fax int@cryo-save.com Cryo-Save AG, 2013 INT-CB Cryo-Save, the leading international family stem cell bank, stores more than 225,000 samples from umbilical cord blood and cord tissue. There are already many diseases treatable by the use of stem cells, and the number of treatments will only increase. Cryo-Save has cryo-preserved samples from over 70 countries on six continents, with ultra-modern processing and storage facilities in Belgium, Germany, Dubai, India and South Africa.