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Cord Blood Stem Cell Banking INFORMATION FOR HEALTHCARE PROFESSIONALS Today, parents and expectant mothers and fathers, have access to more information about child healthcare than probably any other generation in history. They ask their doctors, nurses, midwives, obstetricians and paediatricians, more questions, and demand more answers. And one of these questions concerns collecting and preserving their baby's cord blood stem cells. 02 This booklet is designed to help, by providing you with at least some of the information you will need. It will explain what stem cells are, and what their clinical applications are. It will also detail the accreditations and licences required by organizations in the UK to perform the storage and preservation of stem cells, plus itemize which accreditations are held by Future Health Technologies. 03 04 Source: Steve Gschmeissner/Science Photo Library What are stem cells? Stem cells are the body's very early unspecialized "master" cells. They have two distinct characteristics: • They can self-renew through cell division for the duration of our life. • They have the remarkable potential to develop into other types of cells and tissue, such as red or white blood cells, nerve cells, brain cells or even the cells of the heart. Therefore they serve as a repair system for the body, continuously replenishing other cells. Umbilical cord blood is a rich source of haematopoetic progenitor cells (HPCs) as well as multipotent stem cells called multilineage progenitor cells MLPCs1. More specifically cord blood stem cells include mesenchymal stem cells (MSCs)2 and dendritic cells3,4,5. In fact, cord blood has a significantly higher concentration per volume of primitive HPCs than bone marrow 6,7, thereby making it a good source of cells for transplantation8. When can cord blood stem cells be collected? Stem cells from peripheral blood and bone marrow can be collected at any time. But the procedure for bone marrow collection can be painful and finding a perfect or ideal match could be problematic. Cord blood stem cells, on the other hand, can only be collected at birth. Unfortunately, this precious blood is routinely discarded at birth by the hospital. 05 When was cord blood treatment first performed? The first cord blood transplant was performed in the 1960's. The first successful cord blood transplant was performed in 1988 by Dr E Gluckman on a 5 year old boy with Fanconi Anaemia. He was given a 0% chance of survival 9. The donor was his HLA-identical newborn sister who was known by pre-natal diagnosis to be HLA identical and not affected by the Fanconi mutation. The cord blood was collected during her birth and was then processed and cryopreserved. The transplant was successful without Graft versus Host Disease (GvHD), and the patient is currently alive and free of disease more than 20 years after transplant, with full haematologic and immunologic reconstitution. At the time of the first successful transplant, little was known about the biologic properties of cord blood cells and it was thanks to the pioneering work of H. E. Broxmeyer and E. A. Boyse, who studied the progenitor cell content of cord blood, and of A. D. Auerbach, who realised the pre-natal diagnosis of Fanconi Anaemia, that this transplant was possible. How widespread is the treatment? In the years following that first successful procedure, the number of transplants of HPCs derived from cord blood has steadily increased. Transplants take place - and diseases are treated in children and adults - all over the world. Dr E. Gluckman announced in May 2006 at the International Society for Cellular Therapy conference in Berlin that over 10.000 cord blood stem cell transplants have already been performed10. In June 2008 at the Cord Blood Transplantation Symposium in Los Angeles California, Dr E. Gluckman reported that over 14,000 cord blood transplants have been formally recorded worldwide, but actual numbers are probably closer to 20,000. What conditions are stem cells used to treat? Numerous reports document the feasibility and efficacy of the transplantation of cord blood stem cells for the treatment of a broad range of disorders, including haematological malignancies, solid tumours, constitutional and acquired bone marrow failure syndromes, haemoglobinopathies, congenital immune deficiencies, and inherited disorders of metabolism11,12,13. When properly processed and tested, cord blood stem cells may be used by the entire family; they may be used by the child from which they were collected (autologous use) as well as his/her brothers and sisters and possibly the parents (related allogeneic use) themselves. All properly accredited cord blood stem cell banks perform full testing of the samples. 07 Here’s what various studies indicate about specific conditions: Chronic Myeloid Leukaemia (CML) “Autologous haematopoietic stem cell transplantation (autoHSCT) is a widely used form of treatment for haematological malignancies, including chronic myeloid leukaemia (CML)” D. S. Krause, Massachussetts General Hospital, Boston, MA14. Multiple Myeloma A study on 508 patients with multiple myeloma undergoing autologous stem cell transplantation confirmed that high doses of autologous CD34+ cells shorten haematopoietic reconstitution and reduced hospitalisation15. Lymphoid Malignancies Autologous stem cell transplantation is used in patients with lymphoid malignancies including Hodgkin's disease, non-Hodgkin's lymphoma or Multiple Myeloma16. Neuroblastoma Autologous stem cell transplantation is used in children with high-risk Neuroblastoma17. 08 Autologous transplants Related allogeneic transplants 43.2% 56.8% 35.8% 64.2% Allogeneic transplants Unrelated allogeneic transplants Chart 1: Autologous v Allogeneic Haematopoietic Chart 2: Related v Unrelated Allogeneic Hematopoietic Stem Cell Transplants 2003 - North America Stem Cell Transplants 2003 - worldwide Transplant data for all types of stem cell transplantations performed is collected by CIBMTR (Center for International Blood & Marrow Transplant Research). The data demonstrate that the majority of transplants are autologous.In North America out of the 16900 transplants in the statistics for the year 2003, 9600 (56.8%) were autologous. Of the allogeneic transplants, again the majority are related transplants. Worldwide, out of 13700 transplants in the statistics for the year 2003, 8800 (64.2%) were related (i.e. the samples came from a relative of the patient, not from an unrelated person). Therefore, only a small percentage of the total number of transplants come from an unrelated person. The majority of the transplants are either autologous or from a relative of the transplant recipient. The data was given by the Statistical Center of the Center for International Blood and Marrow Transplant Research (CIBMTR). www.cibmtr.org. The site states that: "The CIBMTR unites and builds on the strengths of two leaders in the field of blood and marrow transplantation, the International Bone Marrow Transplant Registry and the Autologous Blood and Marrow Transplant Registry (IBMTR/ABMTR), and National Marrow Donor Program (NMDP)" A list of conditions for which stem cell transplantation is used worldwide follows. More conditions will be added to the list as time goes by. It should be noted that stem cells are not normally used to treat genetic disorders on the child from which the sample was collected. In this case a sample collected from a sibling is the best option. One major benefit of cord blood is the reduced capacity of cord blood cells to produce an alloreactive response (i.e., an immune response against the recipient). This results in markedly less frequent and less severe graft versus host disease (GvHD)18. Cord blood stem cells are a perfect match for the baby and carry a significant probability of match in other family members, with the probability of an exact match for a sibling being 25%19. "Studies consistently demonstrate that umbilical cord blood (UCB) is an effective alternative source of haematopoietic stem cells (HSC) for adult transplantation with at least comparable results to other HSC sources for adult patients." C. Brunstein, P. Szabolcs: Moving Umbilical Cord Blood Transplantation to Adult Patients, International Society of Cellular Therapy Conference Plenary Session 7: Cord Blood, Berlin, May 4-7, 2006. 09 Conditions that benefit from stem cell transplantation Standard Therapies Anaemias Cancers in the bone marrow (Plasma Cell Disorders) • Aplastic Anaemia • Multiple Myeloma • Congenital Dyserythropoietic Anaemia • Plasma Cell Leukaemia • Fanconi Anaemia • Waldenstrom's Macroglobulinaemia • Paroxysmal Nocturnal Haemoglobinuria (PNH) • Pure Red Cell Aplasia Other cancers • Neuroblastoma Inherited Platelet Abnormalities • Retinoblastoma • Amegakaryocytosis / Congenital Thrombocytopenia • Glanzmann Thrombasthenia Acute Leukaemia • Acute Lymphoblastic Leukaemia (ALL) Myeloproliferative Disorders • Acute Myelogenous Leukaemia (AML) • Acute Myelofibrosis • Acute Biphenotypic Leukaemia • Agnogenic Myeloid Metaplasia (Myelofibrosis) • Acute Undifferentiated Leukaemia • Polycythemia Vera • Essential Thrombocythemia Chronic Leukaemia • Chronic Myelogenous Leukaemia (CML) Inherited Immune System Disorders - • Chronic Lymphocytic Leukaemia (CLL) Severe Combined Immunodeficiency (SCID) • Juvenile Chronic Myelogenous Leukaemia (JCML) • SCID with Adenosine Deaminase Deficiency • Juvenile Myelomonocytic Leukaemia (JMML) (ADA-SCID) • SCID which is X-linked Myelodysplastic Syndromes • SCID with absence of T & B Cells • Refractory Anaemia (RA) • SCID with absence of T Cells, Normal B Cells • Refractory Anaemia with Ringed Sideroblasts • Omenn Syndrome (RARS) • Refractory Anaemia with Excess Blasts (RAEB) Inherited Immune System Disorders • Refractory Anaemia with Excess Blasts in • Kostmann Syndrome Transformation (RAEB-T) • Myelokathexis • Chronic Myelomonocytic Leukaemia (CMML) • Ataxia-Telangiectasia • Bare Lymphocyte Syndrome Lymphomas • Common Variable Immunodeficiency • Hodgkin's Disease • DiGeorge Syndrome • Non-Hodgkin's Lymphoma Burkitt's Lymphoma • Leukocyte Adhesion Deficiency • Lymphoproliferative Disorders (LPD) Inherited Red Cell Abnormalities • Lymphoproliferative Disorder, X-linked • Beta Thalassemia Major • Wiskott-Aldrich Syndrome • Blackfan-Diamond Anaemia • Pure Red Cell Aplasia Phagocyte Disorders • Sickle Cell Anaemia • Chediak-Higashi Syndrome • Chronic Granulomatous Disease • Neutrophil Actin Deficiency • Reticular Dysgenesis 10 Therapies in Clinical Trials Transplants for Cancerous Tumours Transplants for Disorders of Cell Proliferation - • Breast cancer Histiocytic Disorders • Ewing's sarcoma • Familial Erythrophagocytic Lymphohistiocytosis • Renal cell carcinoma • Haemophagocytosis • Langerhans Cell Histiocytosis (LCH or Tranplants for Inherited Disorders Histiocytosis-X) • Cartilage-Hair Hypoplasia • Gunther's Disease (Erythropoietic Porphyria) Gene Therapy • Hermansky-Pudlak Syndrome • Glanzmann Thrombasthenia • Pearson's Syndrome • Severe Combined Immunodeficiency (SCID) • Shwachman-Diamond Syndrome • SCID with Adenosine Deaminase Deficiency • Systemic Mastocytosis (ADA-SCID) • SCID which is X-linked Transplants for Inherited Metabolic Disorders Mucopolysaccharidoses (MPS) Storage Diseases Cellular Cardiomyoplasty • Mucopolysaccharidoses (MPS) • Regeneration of damaged heart muscle by • Hurler's Syndrome (MPS-IH) infusing stem cells or promoting their growth • Scheie Syndrome (MPS-IS) following myocardial infarction • Hunter's Syndrome (MPS-II) • Sanfilippo Syndrome (MPS-III) Auto Immune Diseases • Morquio Syndrome (MPS-IV) • Diabetes Type 1 • Maroteaux-Lamy Syndrome (MPS-VI) • Lupus • Sly Syndrome, Beta-Glucuronidase Deficiency (MPS-VII) Transplants for diseases of the Central • Mucolipidosis II (I-cell Disease) Nervous System • Cerebral Palsy Leukodystrophy Disorders • Multiple Sclerosis (MS) • Adrenoleukodystrophy (ALD)/Adrenomyeloneuropathy (AMN) • Krabbe Disease (Globoid Cell Leukodystrophy) Source: www.parentsguidecordblood.com • Metachromatic Leukodystrophy visited May 20, 2008 Lysosomal Storage Diseases • Gaucher Disease • Niemann-Pick Disease • Sandhoff Disease • Tay-Sachs Disease • Wolman Disease Other Disorders • Lesch-Nyhan Syndrome • Osteopetrosis 11 What conditions could be treated in the future? Exciting developments in the research of treatments appear almost daily in the media, announcing the potential of stem cells to treat a variety of diseases, including Multiple Sclerosis20, Type 1 Diabetes21, Testicular Cancer22,Liver Cancer and to regenerate the heart following a Myocardial infarction23,24. Studies demonstrate the use of cord blood stem cells for cardiac regeneration38,39,40,41. The UK government has already funded a lot of this research and announced in the 2005 Budget a £2.5 Billion investment over the next 10 years. As Dr. E. Gluckman indicated at the International Society for Cellular Therapy Conference in Berlin in May 2006, “there are “ES-equivalent stem cells”, or “unrestricted somatic cells”, in cord blood that can differentiate into osteoblasts, chondroblasts, adipocytes, hepatocytes and neural cells in a homogeneous fashion in various animal models. It is also claimed that this cell population, although rare in cord blood, can be expanded to give a very large number of cells without losing pluripotency. In conclusion, cord blood is a unique biological resource for haematopoietic transplantation, regenerative medicine and scientific research10.” 12 Studies have indicated that: Multi-Lineage Progenitor Cells Umbilical cord blood MLPCs is a (MLPCs) found in cord blood can “new and powerful tool in tissue be differentiated into respiratory engineering and the development of epithelial cells25. more effective ECM scaffolds26.” “Autologous stem cell “Mounting evidence for the transplantation could be a concept that umbilical cord blood safe and valuable method for may serve as a convenient source restoration of neurological of neuronal progenitors28.” function in stroke patients27.” Dendritic Cells are a promising tool of immunotherapy for cancers “We were able to produce “High-dose chemotherapy enough amount of matured Dendritic with autologous stem cell Cells for clinical use and this study transplantation appears to be an provides noteworthy results of generating effective treatment for MS both in a large number of functional DCs terms of clinical and patient- using CD34+ progenitor cells obtained reported outcomes29.” from umbilical cord blood3.” 13 Who preserves What reasons are cord blood there for storing stem cells? cord blood? Following the first successful transplant, Many factors affect the parents' decision the importance of cord blood stem cells to bank their child's cord blood. Of course in medical treatments became recognized the obvious one is that parents see cord among doctors and their storage for future blood stem cells as a valuable resource for use became a pressing need. In 1992, a the future. They see the research findings doctor of biochemistry, David Harris, set published to date and firmly believe that the foundations for the establishment of the potential applications may be of the first private cord blood bank when he benefit to their baby or other biological decided to preserve the cord blood stem family members in the future. In other cells of his newborn son. Since that date, words…they believe it's better to have it it is estimated that over a million parents and maybe not need it, than to need it worldwide have chosen to store their and not have it! child's cord blood in a private facility. The first NHS cord blood bank was set up in the UK in 1996 by the National However, there are circumstances where Blood Service and to date have collected storing cord blood stem cells is more than and cryopreserved over 10,000 donated simply 'insurance'. Where there are real samples. This is based on altruistic cord medical considerations. For instance: blood donation, where donor cord blood is kept in a 'pool' for anyone to use. • If there is a family history of one or Altruistic cord blood donation is still only more of the diseases that use stem cells available in 4 hospitals in the UK 30, 31 so as a treatment. the opportunity to donate is limited. • If the parents are from a mixed race "Collection and freezing of cord blood background. Research has shown that units should be considered strongly in finding a match for this group is very families with a child affected with difficult. haemoglobinopathy or other genetic diseases." • If a baby is born as the result of IVF treatment using donor egg/sperm, it is Royal College of Obstetricians and Gynaecologists Scientific Advisory Committee, Opinion Paper 2, more difficult to trace prospective Revised June 2006. donors, should the need arise. 15 How easy is it to collect umbilical cord blood? “Banking of cord blood has developed to supplement bone marrow stem cell transplantation. Placental umbilical cord blood can be used as an alternative to bone marrow or peripheral blood cells to treat life-threatening disorders of children and adults. Cord blood is collected at no risk to the donor, is less likely than adult bone marrow donations to carry viral infections, brings to the recipient a lower incidence and severity of acute and chronic graft-versus-host-disease.” Sue Armitage et al.:Cord Blood donation, testing and banking: A guide for midwives, British Journal of Midwifery, Vol. 14,(1): 6 - 9, 05 Jan 2006. It's not only easy, it's also non-invasive and risk-free to baby and mother. What's more, it's a procedure that's performed routinely by obstetricians, midwives and nurses in many hospital delivery rooms all over the world, where the newborn is jaundiced or the mother's blood group is Rh negative or for blood typing. You may even be familiar with collecting cord blood yourself. However, there is a protocol that should never, under any circumstances be deviated from. The first priority of any Healthcare Professional in a birthing situation is the health of the mother. Second, the health of the baby. Then, and only then, the collection, if requested, of the baby's cord blood. Many parents who choose to collect and save their babies cord blood will approach their midwife and ask for help and guidance. They will not only ask about the procedure, they will also ask about how their baby's cord blood stem cells will be stored…and who will store them. Many parents will have already 'done their homework'. They may have contacted a number of cord blood storage facilities. They might already know as much as you do about the procedure. 16 17 Who is Future Health? We were the FIRST private family cord blood bank in the UK to receive a full accreditation as a human tissue bank (accreditation awarded in 2004 by the UK's Medicines & Healthcare products Regulatory Agency (MHRA) of the DoH (0083/00/00/0-04)). On April 7th 2006, we received a deemed licence from the Human Tissue Authority (HTA), according to the new EU Tissues and Cells Directives (2004-2006). On 1st September 2006 we were again, the FIRST private tissue bank to receive a 3 year substantive licence from the HTA. The Human Tissue Authority (HTA) regulates the processing and storage of human tissue, for a number of Scheduled Purposes set out within the Human Tissue Act. As part of their regulatory function, the Authority carries out inspections of licensed establishments, making sure that certain activities are only carried out under the authority of a licence granted by them. At the end of 2007 we completed the construction of our new labs. The Human Tissue Authority (HTA) inspected the new labs as well as the rest of the facilities and renewed our licence for a further 3 years, Licence 22503 02-04-08. This means that everything, from our collection methodology, through to our laboratory processes and storage facilities, has been rigorously inspected and fully approved. Our own purpose built laboratory strictly adheres to the guidelines of the Code of Practice for Human Tissue Banks, the guidance on the Microbiological Safety of Human Organs, Tissues and Cells used in Transplantation and current Good Manufacturing Practice (cGMP). We also adhere to all current EU directives. We use the very latest processing and cryopreservation equipment, and operate under the very highest security and monitoring protocols. For instance, we require that the collection be made only by a Healthcare Professional, and transported by approved medical couriers in thermal shipping boxes, for protection against adverse temperature conditions. Future Health is based in Nottingham UK, where we have our own purpose-built laboratories, on-site storage facility and administrative offices. We have already collected samples from over 35 countries in the world. We have offices in over 15 countries around the world. Our network of offices is rapidly expanding in order to meet the local needs in each country and culture. Being an accredited facility brings peace of mind and valued reassurance not only to parents, but also to Healthcare Professionals. What does it mean to have a licence as a Human Tissue Bank? • Not a simple laboratory licence. We can legally handle human tissues and cells • We can legally transport human cells (biological material) within and across countries according to EU Directives • Samples can be used by: 1. Donor / child (autologous use) 2. Any family member or other person (allogeneic / heterologous use) • The sample is legally accepted from all the hospitals and transplantation centres as an injectible substance. The HTA is now the Competent Authority in the UK under the new EU Tissues and Cells Directive, with responsibility for licensing the storage of human tissues and cells, including haemopoietic stem cells. (EUTCD Commission Directive 2006/86/EC, 24 October 2006, 2006/17/EC, 8 February 2006. Directive 2004/23/EC, 31 March 2004). 18 Cord blood collection kit All necessary equipment for the collection is included in the kit that the parents will bring with them to the delivery room. The kit contains a purpose-designed cord blood collection bag, enclosed in an individual sterile package, with two needles for ease of collection and to reduce the possibility of contamination. The bag contains the correct amount and type of anticoagulant for cord blood preservation. In addition, the cord blood must be collected using Aseptic Technique to prevent contamination of the sample. The sample is transferred in special isothermic packaging designed by Future Health, which is accredited (BVI C-07.004) according to the regulations concerning the safety of transportation of biological substances (UN 3373, IATA PACKING INSTRUCTION 650). 20 21 Advanced cryopreservation facility Stem cell separation and preservation are carried out by specialised, scientific laboratory personnel - in accordance with strict guidelines, in line with our MHRA accreditation and HTA licence. The samples are processed in sterile, Grade B clean rooms with Grade A laminar flow work areas, in a positive pressure controlled atmosphere. The air within the controlled area passes through hepa filters and is continuously renewed. The entrance from the Grade C lab area to the Grade B clean rooms is through double pressure doors, accessed only by lab technicians, who wear sterile full body suits, completely covering the entire body from head to toe. Room sterility is continuously monitored by the use of agar plates, the testing of which is performed by the Nottingham University Hospitals Trust, as an additional precaution. These strict conditions of sterility are superior even to a hospital operating theatre. This is a measure of assurance above and beyond the requirements of the UK Department of Health. Cord blood stem cell samples are placed in special, laminated cryobags, which is a vital part of our closed processing system. This prevents any contact with atmospheric air. They are not placed in vials, as these have been known to cause problems in long term sample cryostorage. The cryobag consists of two, independent chambers, permitting the multiple future use of each sample. This bag is then bar coded with a metallic label, to ensure the positive identification of each sample, then sealed and placed in an external protective bag. The double-bagged sample is then placed in a metal canister for additional protection against possible mechanical damage. The metal canisters are then bar coded with the same unique number as the cryobags. They're then stored in the vapour phase of liquid nitrogen in automated cryostorage tanks as opposed to being immersed in liquid nitrogen. This prevents the possibility of cross contamination between samples in the liquid phase. Storage temperature is controlled and monitored on a 24 hours basis. In the remote case of a prolonged power failure or malfunction of the automatic system, the tanks are designed to be operated manually for indefinite periods of time, ensuring in every case the proper long term cryopreservation of the samples. Our facility has 24/7 recording of storage condition parameters and 24/7 security systems and security personnel on site. Future Health specialises only in processing and storing cord blood stem cells. All client information is handled according to the UK Data Protection Act. 22 Facts and misconceptions Misconception: All cord blood stem cell banks are fully accredited and fully licensed to the highest standards. FACT: That's not the case. Future Health is the first family cord blood stem cell bank in the UK to be accredited by the Medicines and Healthcare Products Regulatory Agency and fully licensed by the UK Human Tissue Authority - according to the new EU Tissue and Cells Directives (2004-2006). Misconception: Preserving and banking cord blood is not justifiable, as the probability of a family ever needing to use it is extremely low. FACT: New data published in March 200832 indicates the probability of an individual in the United States needing a stem cell transplant, using either one's own stem cells or those from a donor, is much higher than previously stated. This new research says that as many as 1 in 200 people will receive a stem cell transplant during their lifetime, based on current therapeutic use of hematopoietic stem cells. These outcomes stand in stark contrast to previous estimates that suggested a much lower probability. Misconception: The Healthcare Professional who collects the cord blood, will be held responsible and liable if, for any reason, the cord blood isn't collected, or not enough blood is collected. FACT: Any parent who asks their Healthcare Professional to collect cord blood for storage with Future Health, signs a legal disclaimer form. This legally exempts the Healthcare Professional from any responsibility, should the sample not be collected or should anything go wrong. They would have our full support on any such issue. 24 Misconception: A person will never be able to receive an autologous cord blood transplant because it would have the traits of the disease. FACT: Autologous stem cell transplants have been routinely performed throughout the world to treat haematological disorders and various solid tumours 4,14-17,24. Stem cells in cord blood should be normal and free of malignancy, giving them a potential advantage over autologous cells collected during haematological remission from a patient with malignancy32. According to a new study published recently37 the lifetime probability that an individual will undergo a stem cell transplant with his own stem cells for treatment is 1:435. Cord blood may also be used by the siblings or parents when there is sufficient compatibility. It is always up to the doctor to decide but cord blood may even be used when there are cases where there is a four out of six HLA type compatibility. Misconception: When cord blood is stored for the family in a private facility, it deprives the NHS of a potentially donated sample. FACT: Every year, more than 99% of the potential cord blood samples from over 700,000 births in the UK are discarded. There are potentially far more samples available than the National Blood Service could possibly store. What's more, donating cord blood is available in only 4 hospitals in the UK30. Recent reports suggest that only 30% of donated cord blood is actually kept, due to various factors related to the donors. Most parents do not have the option of donating their cord blood, and many feel that this resource is too valuable to simply be thrown away. Misconception: Cord blood stem cells have only been used experimentally. FACT: Since the first successful cord blood transplant in Paris in 1988, more than 10,000 cord blood transplants have taken place as part of standard medical treatments worldwide10. In June 2008 at the Cord Blood Transplantation Symposium in Los Angeles California, Dr E. Gluckman reported that over 14,000 cord blood transplants have been formally recorded worldwide, but actual numbers are probably closer to 20,000. 25 Facts and misconceptions Misconception: Privately stored cord blood stem cells may only be used by the child from whom they were collected. FACT: Cord blood stem cells are 100% compatible with the person from which they were collected from. However, they may also be used by the parents and siblings of the child since there is a significant possibility of histocompatibility among family members. The allogeneic use of a sample is only allowed if the sample was processed and stored in a fully licensed bank such as Future Health. This increases both the scope and the chances of use of the sample. If a sample is stored in a bank that does not have a Human Tissue Bank licence then it can only be given back to the donor (autologous use only). Misconception: Cord blood stem cells can be used in children but not adults. FACT: “Studies consistently demonstrate that umbilical cord blood (UCB) is an effective alternative source of haematopoietic stem cells (HSC) for adult transplantation with at least comparable results to other HSC sources for adult patients36.” The first adult transplantation in the UK was carried out in 2002 in Newcastle. 26 Future Health - committed to supporting you We at Future Health are committed to providing up to date information for all Healthcare Professionals. We are happy to provide any information on the stem cell banking or the collection procedure that you require, either individually or as a group workshop. For any more information If you have any queries, or need to speak to Future Health in person, simply pick up the phone and call us on +44 (0)115 967 7707 or email: firstname.lastname@example.org References: 1. Knudtzon, S. (1974): In vitro growth of granulocytic colonies from circulating cells in human cord blood, Blood 43:357-61. 2. C. Tsai et al.: Enhancing the engraftment of umbilical cord blood haematopoietic stem cells by coinfusion of umbilical cord-derived mesenchymal stem cells in a non/SCID mouse model, Cytotherapy, Volume 8 Supplement 1, 240, 2006. 3. S. Lee et al.: Efficient generation method of functional dendritic cells derived from human cord blood CD34+ progenitors by two-step culture for clinical application, Cytotherapy, Volume 8 Supplement 1, 123, 2006. 4. Borras FE, Matthews NC, Patel R, Navarrete C: Dendritic cells can be successfully generated from CD34+ cord blood cells in the presence of autologous cord blood plasma, Bone Marrow Transplant. 2000 Aug;26(4):371-6. 5. G. Diego Miralles et al.: CD34+CD38-lin- Cord Blood Cells Develop into Dendritic Cells in Human Thymic Stromal Monolayers and Thymic Nodules, The Journal of Immunology, 1998, 160: 3290-3298. 6. Smith, S., and H. E. Broxmeyer. 1986. The influence of oxygen tension on the long-term growth in vitro of haematopoietic progenitor cells from human cord blood. Br. J. Haematology. 63:29-34. 7. Nakahata T, Ogawa M: Identification in culture of a new class of haematopoietic colony-forming units with extensive capability to self renew and generate multipotent haematopoietic colonies. Proc Nat’l Acad Sci USA 79: 3843-3847, 1982. 8. MP Bodger et al., Blood Volume 69, Issue 5, pp. 1414-1418, 05/01/1987. 9. Gluckman E Broxmeyer HE, Auerbach AD et al.: Haematopoietic reconstitution in a patient with Fanconi’s Anaemia by means of umbilical cord -blood from an HLA -identical sibling. The New England Journal of Medicine 1989: 321: 1174-1178. 10. E.Gluckman: Current Results and Future Progress in Cord Blood Transplant, Plenary Session 7, ISCT Berlin, May 4-7, 2006. 11. Gluckman et al.: Outcome of Cord-Blood Transplantation from Related and Unrelated Donors, N Engl J Med 1997;337:373. 12. Franco Locatelli: Factors Associated With Outcome After Cord Blood Transplantation in Children With Acute Leukaemia, Blood, Vol. 93 No. 11 (June 1), 1999: pp. 3662-3671. 13. Rocha V, Sanz G, Gluckman E; Eurocord and European Blood and Marrow Transplant Group. Umbilical cord blood transplantation. Transfus Clin Biol. 2001 Jun; 8(3):146-54. 14. D. S. Krause et al.: Engraftment of BCR-ABL+ Leukemia-initiating cells is mediated by selectins and their ligands, Cytotherapy, Volume 8 Supplement 1, 254, 2006. 15. J. Klaus: Effect of CD34+ cell dose on haematopoietic reconstitution and outcome in 508 patients with multiple meyloma undergoing autologous peripheral blood stem cell transplantation, Cytotherapy, Volume 8 Supplement 1, 263, 2006. 16. D. Coso: PEG-G-CSF to mobilize peripheral blood progenitors for autologous transplantation in patients with lymphoid malignancies, Cytotherapy, Volume 8 Supplement 1, 259, 2006. 17. G. R. Pierson: Activated T-cell infusions improve immune recovery after tandem CD34+ selected autologous peripheral blood stem cell transplants in children with high-risk Neuroblastoma (NBL), Cytotherapy, Volume 8 Supplement 1, 159, 2006. 18. Rocha V et al.: Graft-versus- Host Disease in Children Who Have Received a Cord-Blood or Bone Marrow Transplant from an HLA-Identical Sibling NEJM -- June 22, 2000 -- Vol. 342, No. 25, pages 1846-54. 19. my.webmd.com/hw/health_guide_atoz/tv7978.asp accessed 29/04/05. 20. Pluchino S et al. Nature (Vol 422, p 688) 17 April 2003 Multiple Sclerosis. 21. Smukler S, Seaberg R, Prof D van der Kooy. 22nd Aug 2004 online edition of Nature Biotechnology diabetes. 22. Journal of Clinical Oncology, Vol 18, No 19, pp 3346-3351, 2000 Testicular Cancer. 23. Antonio Maria Leone et al.: European Heart Journal, Feb 2005. 24. Leor J et al.: Human umbilical cord blood cells: a new alternative for myocardial repair?, Cytotherapy 2005; 7:251-7. 25. M. Berger et al.: Differentiation of umbilical cord blood-derived Multi-Lineage Progenitor Cells into respiratory epithelial cells, Cytotherapy, Volume 8 Supplement 1, 258, 2006. 26. S. L. Sprague et al.: Utilization of human cord blood-derived Multi-Lineage Progenitor Cells (MLPC) in two and three-dimensional tissue engineering models, Cytotherapy, Volume 8 Supplement 1, 190, 2006. 27. S. Ha et al.: Autologous bone marrow stem cell transplantation for stroked patients, Cytotherapy, Volume 8 Supplement 1, 206, 2006. 28. A. Nagler et al.: Neuronal stem cell differentiation from human umbilical cord blood (HUCB): The role of nerve growth factor (NGF), Cytotherapy, Volume 8 Supplement 1, 155, 2006. 29. R. A. Ivanov et al.: Treatment outcomes in Multiple Sclerosis (MS) patients after high-dose chemotherapy (HDCT) with autologous stem cell transplantation (ASCT): Long term follow-up, Cytotherapy, Volume 8 Supplement 1, 56, 2006. 30. The Donor Magazine Spring 2005 page 14. 31. Royal College of Obstetricians and Gynaecologists Scientific Advisory Committee, Opinion Paper 2, Revised June 2006. 32. Wiley, JM & Kuller JA: Storage of newborn stem cells for Future Use Obstetrics and Gynaecology Vol. 89, No 2. February 1997. 33. Journal of Paediatric Haematology Oncology (1997, 19:3, 183-187). 34. Hematopoietic engraftment and survival in Adult recipients of umbilical Cord blood from unrelated donors The NEJM (June 14, 2001 344:24, 1815-1822). 35. Nietfeld JJ and Verter, F: Statistics of Autologous Cord Blood Storage and Use ICBS 6th International congress (1-3 October 2004). 36. C. Brunstein, P. Szabolcs: Moving Umbilical Cord Blood Transplantation to Adult Patients, International Society of Cellular Therapy Conference Plenary Session 7: Cord Blood, Berlin, May 4- 7, 2006. 37. Nietfeld JJ, Pasquini MC, Logan Br, Verter F, Horowitz MM. Lifetime Probabilities of Hematopoietic Stem Cell Transplantation in the U.S. Biology of Blood and Marrow Transplantation March 2008; 14:316-322 38.Harris DT, Badowski M, Ahmad N, Gaballa MA. The potential of cord blood stem cells for use in regenerative medicine. Expert Opinion on Biological Therapy. 2007;7(9):1311-1322. 39. Ma N, Stamm C, Kaminski A, Li W, et al. Human cord blood cells induce angiogenesis following myocardial infarction in NOD/scid-mice.Cardiovascular Research. 2005;66(1):45-54. 40. Ma N. Ladilov Y, Kaminski A, Piechaczek C. Stamm C. Umbilical cord blood cell transplantation for myocardial regeneration. Transplant proc. 2005;38(3):771-3. 41. Nishiyama N, Miyoshi S, Hida N, et al. The significant cardiomyogenic potential of human umbilical cord blood-derived mesenchymal stem cells in vitro. Stem Cells. 2007;25(8):2017-24. 27 Future Health Technologies Ltd. 10 Faraday Building, Nottingham Science & Technology Park, University Boulevard, Nottingham NG7 2QP, United Kingdom Tel: +44 (0)115 967 7707 Fax: +44 (0)115 967 7836 email@example.com www.futurehealth.co.uk June 2008 V3.2
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