Vita 34 Parents Guide to umbilical Cord Blood Banking secure first-class innovative
Contents INTRODUCTION 3 THERAPEUTIC USES OF STEM CELLS 4 STEM CELLS IN CANCER TREATMENT STEM CELLS IN THE TREATMENT OF AUTOIMMUNE DISEASES STEM CELLS IN REGENERATIVE MEDICINE STEM CELLS FROM THE UMBILICAL CORD 5 USAGE OF CORD BLOOD 6 HOW UMBILICAL CORD BLOOD BECOMES A STEM CELL UNIT 7 THE STORAGE PROCESS TYPES OF CORD BLOOD BANKS 8 PUBLIC CORD BLOOD BANKS PRIVATE / FAMILY CORD BLOOD BANKS HYBRID BANKING - VITAPLUSDONATION 9 WHO CAN DONATE CORD BLOOD 10 TAKE HOME MESSAGE 10 2
Introduction To collect and store the umbilical cord blood of a baby when it is born is becoming increasing common practice, because the blood in the umbilical cord is very valuable. The cells contained in the umbilical cord blood have therapeutic value for many diseases. Cord blood has been used in transplant medicine since 1988 and, over the last 27 years, this activity has grown rapidly. Further stem cell reseach is advancing all the time and potential new uses increase over the years. By choosing to bank this cord blood, parents could help their child, a family member, or even a stranger. Many parents acquire information from several sources, such as friends and family, print media and the internet. Some information is contradictory and not comprehensive. This brochure is intended to address educational requirements and to answer many questions that parents-to-be may have. 3
Therapeutic uses of stem cells Stem cells in cancer treatment The transplantation of stem cells in cancer treatment has been a therapeutic standard for more than 30 years. In cancer therapy, stem cell transplantation is not primarily intended to cure the patient, but rather to fight the undesirable side effects. Many dangerous cancers can be treated successfully by means of highly dosed chemotherapy or irradiation. However, haematopoiesis and immune system break down as a consequence. That is why the patient needs the transplantation of haematopoietic stem cells after the treatment. With 57 percent of all cases, the autologous transplantation is the most commonly used application. In further 23 percent of the cases, allogeneic stem cells are applied. In 20% of cases stem cells from family members were used. 1 Stem cells from umbilical cord blood become rapidly more important in the treatment of cancer. 2009 was the first time in the USA, where the number of treatments using umbilical cord stem cells exceeded the number of treat ments using bone marrow stem cells. 2 Stem cells in the treatment of autoimmune diseases In serious cases, doctors have included the stem cell treatment in the therapeutic concept for autoimmune diseases. A highly dosed chemotherapy destroys the maldeveloped immune cells. Then, a new immune system is built up by transplanting autologous haematopoietic stem cells, which matures without any defect or maldevelopment. Meanwhile, stem cell transplantations have been applied successfully in the treatment of various autoimmune diseases, like e.g. severe forms of multiple sclerosis. Stem cells in regenerative medicine Cell-based therapies belong to the promising fields of medical research. These therapies are mostly based on autologous cells, stem and precursor cells, which can be used in the treatment (regeneration) of defects in diseased tissue. The potential range of applications of cell-based therapies includes disease patterns like cardiovascular diseases (e.g. heart attack, stroke), the wear of cartilage and joints (e.g. knee joint, intervertebral disc), and neurological diseases (e.g. Parkinson s, Alzheimer s). 1 Passweg JR et al.: The EBMT activity survey: 2013. Bone Marrow Transplantation (2015), 1-7 2 Wagner JE, Gluckman E.: Umbilical cord blood transplantation: the first 20 years. Semin Hematol. ;47(1):3-12 (2010). doi: 10.1053/j.seminhematol.2009.10.011. 4
Stem cells from the umbilical cord 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. 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 at a glance: 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. Adult stem cells are ethically unobjectionable. 5
Usage of cord blood Cord blood has been used for more than 25 years in therapeutic applications 1, primarily in the treatment of cancer and blood diseases. Since then there have been over 30,000 transplants in the world. 2 An increasing number of people are profiting from further progress in stem cell medicine, among them many children. With increasing age, however, occurrences of degenerative diseases such as heart attack, stroke or diabetes are more frequent. Stem cell therapy offers an even greater potential for their treatment. Experts expect that in the future every seventh person up to the age of 70 years will need stem cells for the treatment of cardio-pulmonary diseases, and correspondingly the need for cryopreservation and the reliable storage of cells and tissues will increase. The following table shows on the example of Germany a list of new diagnoses: Number of new diagnoses p.a. in Germany Stroke 270,000 Heart Attack 300,000 Cancer 500,000 Cancer (Children and adolescents up to 15 years of age) Type-1 Diabetes (Children and adolescents up to 14 years of age) 1,800 2,100-2,300 Congenital heart defects 5,000-6,000 Early childhood brain damage (infantile cerebral palsy) 1,400 1 http://parentsguidecordblood.org/press/ 2 Ballen, K.K.; Gluckman, E.; Broxmeyer, H.E.: Umbilical cord blood transplantation: the first 25 years and beyond. Blood:122(4); July 25,2013 6
How umbilical cord blood becomes a stem cell unit 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. Professional preparation and cryo-preservation creates the source material for a stem cell unit complying with pharmaceutical quality standards. The Storage Process After parents decided to use Vita 34 to secure their child s stem cells, we send them the collection kit, which will be opened by the doctors or the midwife at the clinic. After birth when 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 Vita 34 as soon as blood and, if applicable, tissue were collected successfully. Our reliable courier service transports the package to Leipzig for processing and storage. Our 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. Complex tests serve to document and secure the quality of the stem cell deposit. Umbilical cord blood and tissue are prepared for being processed in the clean room. Later, the preparations are protected by aluminium caskets initially cooled down to -145 degrees Celsius in special freezers. Finally, they are stored in cryo-tanks in the vapour phase over liquid nitrogen at -190 degrees Celsius. 7
Types of cord blood banks There are public and private / family cord blood banks. The process of acquiring the cord blood, medical tests and actual storage is very similar in both types. The European Union (EU) issues directives regulating standards of quality and safety relating to the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. These directives apply to all cord blood banks - public or private that are active on the territory of the European Union. Public cord blood banks In public cord blood banks, the parents sign a consent form to donate the cord blood unit. The cord blood unit is entered into a national or international registry anonymously so that doctors can search these databanks for matching donations for a transplant patient. Parents do not have any costs, these are covered by public or charitable funds. Up to 70% of cord blood units are discarded due to lack of active cell count. A donation, even if stored, is not available to the child or family of the donor. It might have been used for another patient or discarded. Private / family cord blood banks Private / family cord blood banks store cord blood for the use by the baby s family and will always remain available to them. The cord blood unit might some day be needed by the baby or a family member who is a close enough match (typically a sibling). Costs for processing and storage are born by the parents. Most private / family cord blood banks have a number of different storage periods and payment plans. Private banks are subject to respective national regulations that, in Germany is even more stringent than the EU Directives. 8
The German Pharmaceuticals Act (Arzneimittelgesetz, AMG) is the overriding regulation governing the manufacturing requirements for allogenic and autologous stem cell preparations, the necessary staffing, and the establishment of quality management. Vita 34 complies to all laws applicable, in detail: The German Transplantation Act (TPG) and the Transfusion Act (TFG) The German Pharmaceutical and Agent Production Directive (AMWHV) The guidelines on the production and application of hematopoietic stem cells The Hemotherapy Guideline on the Collection of Blood and Blood Components, as well as the Application of Blood Products of the German Medical Association and the Paul-Ehrlich Institute (PEI) Good Manufacturing Practice Guidelines (GMP) Vita 34 has implemented the legal requirements in corresponding working instructions (SOP Standard Operating Procedure). SOPs define all manufacturing steps from anamnesis to collection, manufacturing to use. In important areas they even exceed the legal requirements. All employees are correspondingly trained to observe these strict process guidelines. All stem cell units stored at Vita 34 are insured that would provide financial resources in the case of possible insolvency, such that the stem cell unit will be stored properly and monitored for 50 years. Hybrid banking VitaPlusDonation Donate or store umbilical cord blood privatly? A question that occupies many parents. Since 2007 VitaPlusDonation has allowed parents to provide for their own child with a private umbilical cord blood deposit and, in addition, make these stem cells available to another ill person to support the treatment and the recovery process. The donation option does not involve any additional costs: Parents only pay the fee for the storage of the umbilical cord blood in accordance with the selected product option. This fee will be refunded in case the umbilical cord blood is applied for a patient. 9
Who can donate cord blood for a public bank If mother and child have no severe health issues it is possible to store the cord blood of a child for public use. But, under certain conditions, mothers are not allowed to donate cord blood. Some of the conditions are: Twins or multiple births, twins and other multiples are typically smaller and do not have enough umbilical cord blood for transplants, Premature births: small babies typically do not have enough cord blood for transplants, and these births often involve complications, When the baby s mother, father or siblings have had some type of cancer, When the mother has diabetes and takes insulin that contains animal products, When the mother has received an organ or tissue transplant in the last 12 months, When the mother has had a tattoo or ear, skin, or body piercing in the last 12 months, in which shared or non-sterile inks, needles, instruments or procedures were used, When the mother has lived in a part of the world where certain diseases that are carried in the blood are more frequently contracted. Other criterias apply for private banking. Requirements to participate in VitaPlusDonation If parents 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. Take home message The challenge is to inform parents-to-be objectively about stem cells, what they are and their potential. The existence of public and private banks should not leave parents in a dilemma to choose between them but offer the possibility to make an informed decision for private banking, a public donation or a combination of both. Your child s umbilical cord blood is a unique source of stem cells. Take this one-time opportunity at birth. Whatever the choice parents-to-be will make, whether to store cord blood in a public or private / family blood bank, stem cells are so valuable and a unique opportunity for every child. If you have any questions do not hesitate to contact us. Our team of expert counsellors is ready to answer any of your questions concerning the topic of stem cells from umbilical cord blood and umbilical cord tissue in a professional and comprehensible way. 10
Vita 34 AG Deutscher Platz 5a D-04103 Leipzig Telephone: 0800 034 00 00 (gebührenfrei) oder +49 (0) 341 48792-0 Fax: +49 (0) 341 48792-20 E-Mail: contact@vita34.com www.vita34.com www.facebook.com/vita34 secure first-class innovative