What is cord blood? DKMS Cord Blood Bank Information referring to cord blood donation During pregnancy the umbilical cord supplies your baby with everything necessary for a good development. For this purpose the so-called cord blood circulates between the mother s and child s organisms and the baby gets e. g. nutrients and protection against infections. After birth and cutting the umbilical cord, the cord is no longer needed. Mother and child are now separated. However, the cord blood has not become useless. As it contains, amongst others, stem cells that can be donated to other persons. Otherwise it would be discarded. For what purpose cord blood can be donated? Stem cell transplantation is a promising treatment for patients with malignant, hereditary and acquired diseases of the hematopoietic system (e. g. leukemia, thalassemia, aplastic anemia and others) as well as with enzyme disorders. These cells can be collected from the bone marrow or from the circulating blood of volunteer donors after having their blood treated with a stimulating factor. Stem cell transplantation from cord blood is an equivalent possibility. Your donated cord blood unit will be processed, tested and cryopreserved. If the results of all the testings are satisfying, your donation can be released for stem cell donor search and consequently to patients all over the world. Cord blood that does not meet the quality criteria has to be discarded or can be used for scientific research, validation and quality controls. You can ask for the specific use, especially in case of release for research. It is warranted that cord blood units are only delivered in case of ethical and proved scientific purposes. Prerequisites for cord blood donation Cord blood donation is a blood donation that has to be handled according to legal standards (e. g. German Drug Law, Transfusion Law, guidelines of the German Medical Association). Therefore, before donation some formalities are necessary to be completed. Besides this information leaflet you will receive a medical history questionnaire including questions referring to your medical history and an informed consent. You have to fill in and sign both documents. What is the personal information needed for? Name and address of the mother and, if applicable also the father, are required to inform the mother respectively the parents, about the successful processing or disposal of the donated umbilical cord blood. The phone number is required for quick access and the number of patient for the identification in case of any inquiry call. Finally, the telephone number is needed to check the current health status of the child in case of a request for a patient. Human tissue characteristics and their combinations differ from region to region and there is a higher probability of matching within an ethnic group. In regions with rare tissue characteristics, there is often no or very low activity of donor registries and cord blood banks. The information of family origin also allows a faster and more specifically search for matching donors. Cord blood collection On the day of delivery, samples of your blood (approx. 20 ml blood in 4) will be taken. After child birth, the umbilical cord will be clamped and cut and the baby will be cared for. Then the cord blood (average 60 ml) will be collected in a sterile bag. At no time there is any disadvantage or risk, neither for you nor for your baby. Anlage 12 zur SOP-Nr.: CB-05-01-01-17, gültig ab 01.06.2015, Seite 1 von 2
After being transported to the DKMS Cord Blood Bank the cord blood will be processed. Afterwards, the stem cells will be stored vapor phase of liquid nitrogen below -150 C. Simultaneously the typing of the mother s blood and the CBU will be carried out. Among others there will be tests for infectious diseases relevant for transplantation (lues, hepatitis B/C, cytomegalic inclusion disease, HIV and HTLV a. o.) and for haemoglobinopathy. Furthermore, the tissue type will be characterized. Collected data of mother and child are linked within the computer system of the DKMS Cord Blood Bank for an indefinite period. Cord blood units which correspond to the required criteria are transmitted by the DKMS German Bone Marrow Donor Centre ggmbh to local and international donor registries. This information is thus available for patients suffering e.g. from blood disorder and for whom a therapy with stem cell transplantation has been planned. All donor data are made anonymous. Is it possible to use and store the cord blood for my newborn baby? There is a possibility to store cord blood of a newborn baby for his or her own use. Concerning the present state of the scientific knowledge there are not any fields of application where this so-called autologous cord blood is generally used. However, it cannot be ruled out that there will be developed possibilities of application that the stored cells can be used for this purpose in future. In case of private storage, the cord blood unit is primarily entitled to the child and only in exceptional cases to the family of the child. Allogeneic directed donation Allogeneic directed donation is a special case when the cord blood is donated for a sick sibling or a relative of first grade when an indication for transplantation is already present or possible. In case of an allogeneic directed donation, the preparation can only be used for the sick recipient. If you have any questions concerning the cord blood storage for your own child or allogeneic directed donation, we are pleased to give you further information. What has to be done? For donation please contact a hospital cooperating with the DKMS Cord Blood Bank. You will be informed in detail about the complete procedure of cord blood collection and you will obtain the required documents. The informed consent you signed and the medical history questionnaire you filled in will be sent to the DKMS Cord Blood Bank in Dresden together with other documents and the cord blood unit, where it will be analysed. The decision on acceptance, processing, storage and release for delivery of your cord blood unit is corresponds to the persons of the DKMS Cord Blood Bank who are responsible according to the German Drug Law. If your Cord Blood is cryopreserved, retained samples of you and your child will be stored in any case for potential infectious disease re-testings. Should any reasons arise referring to your donation that could harm the quality of the cord blood unit (e. g. infectious disease as HIV, cancer, severe diseases of the hematopoietic system of you or your child) in future, please communicate this information immediately to the DKMS Cord Blood Bank. Herewith we assure you that every information will be treated confidentially and that after a confidential withdrawal procedure your donation will not be used anymore. If information on the cord blood unit you donated is requested for a patient, the DKMS Cord Blood Bank will call you to get information on your child s medical history. This has to be done for subsequent quality assurance and is necessary to exclude diseases that could not be detected at the time of donation. The decision you take on cord blood donation is voluntary. Should you decide against cord blood collection, you will not have any disadvantages or costs. Withdrawing the informed consent (except for the confidential withdrawal procedure) will not be possible after examination and cryopreservation of the cord blood unit. All information received from you, e. g. personal data, are subject to confidentiality and will be used only anonymously for the central data exchange. The data will be kept strictly confidential and will only be available in exceptional cases by national and international authorities during DKMS Cord Blood Bank inspection. Hopefully, we could make cord blood donation more comprehensible to you with this information. Should you have any questions, please feel free to contact us or a cooperating hospital. The staff of the DKMS Cord Blood Bank is pleased to be available by telephone under 0351 / 250-966 0! Anlage 12 zur SOP-Nr.: CB-05-01-01-17, gültig ab 01.06.2015, Seite 2 von 2
Name, First name: Date of birth Address: (street, zip code, town) Phone-no. Mother Father (desired) Informed consent to Cord Blood collection and usage Hereby I agree to the planned collection und usage of the cord blood of my child as described below. I have been informed on cord blood donation according to the information leaflet handed over to me and I had the opportunity to ask questions concerning this that have been answered to my satisfaction. In this context I will provide personal and family medical history and permit the hospital personnel to review the medical records of me, the child and birth. I agree to testing the cord blood unit and blood samples taken from me referring to infectious pathogens (indirect and direct detection of viruses (e.g. HIV, hepatitis, CMV), microorganisms (e.g. syphilis pathogen)) and haemoglobinopathies (inborn error of haemoglobin synthesis) as well as biological factors as a prerequisite for the release of stem cells from cord blood and for comparison with potential transplant recipients. The material to be examined contains sensitive health data. Furthermore infectious findings with a potential of transmission will be communicated to me. I also agree to the storage of retain samples and, if necessary, renewed sample collection. I agree for my child that the cord blood is released for transplantation to a patient not personally known to me. The persons responsible in the sense of the German pharmaceutical law will decide on the use of the CBU. Furthermore I agree for my child that the cord blood unit is used for transplantation only if it meets all quality criteria. Otherwise it can be used for validations and quality controls and can be provided for scientific purposes. Cord blood is provided to external research facilities without transmission of corresponding individual-related data. Anytime I can obtain information concerning that on demand. No, I don t agree for my child to the afore mentioned usage of the cord blood for scientific purposes for validations and quality controls. The decision against the above-mentioned points has no negative consequences for me. I agree for my child that the property of the collected cord blood passes on to the DKMS Cord Blood Bank so that the same may dispose on it for the purposes described. I agree for my child that the DKMS Cord Blood Bank may contact me for getting information on my child s health history before transplantation of the cord blood. I know that after collection and processing of the cord blood it is no longer possible to withdraw the informed consent to the usage of these body tissues. It has been assured to me that the donation will not be used after a confidential withdrawal procedure. Informed consent to the use of individual-related data I assert the correctness of the above-mentioned personal data of mother, father and child and agree to the ascertainment, handling and usage of these data by the DKMS Cord Blood Bank for the purposes of donor research for compatible stem cell donors for patients worldwide. These recorded personal data are saved and linked by the DKMS Cord Blood Bank for an indefinite period. Data necessary for the transplant selection can be exchanged with national and international stem cell registries to find compatible transplants on this basis To keep the Registry updated, I will inform the DKMS Cord Blood Bank about a change of residence. If I miss to do this, I agree that it can be inquired at the Registration Office. Me and my child can have the right to revoke the informed consent to the data use in written form to the DKMS Cord Blood Bank at any time. Date, place Date, place Name, Signature (Informing physician of the hospital) Signature Signature (Mother) (Father, if entitled to custody and authorised to represent, too) Anlage 10 zur SOP-Nr.: CB-05-01-01-17, gültig ab 01.06.2015, Seite 1 von 1
Medical history questionnaire For subsequent release of the donated cord blood unit, it is absolutely necessary that you complete this questionnaire conscientiously and if possible unattendedly (max. 48 hours prior to delivery). Should you have any further question, please feel free to contact us on phone-no. 0351 / 250-966 0. We are pleased to help you. All questions answered with yes, need to be explained further considering kind of illness, beginning, duration, and medication. Please use panel Comments on page 3 for your explanations. Mother (use sticker if available) Name: First name: DOB: MEDICAL HISTORY OF THE MOTHER Mark your answer with a cross! You may give confidential information directly to the physician. 1. During the last 4 weeks did you have any infection (e.g. common cold, diarrhea) If so: Specify? When? No Yes accompanied with fever: No, Yes take any drug, get any injections? If so: Specify? No Yes have any contact to persons with infectious diseases (e.g. rubella, measles, mumps/epidemic parotitis)? No Yes 2. Have you been vaccinated against rabies during the last 12 months or been vaccinated against hepatitis B or been vaccinated with live vaccine (e. g. yellow fever, typhus, varicella, measles, mumps, German measles, cholera) during the last 4 weeks? If so: Specify? No Yes 3. During the last 4 months have you had any piercing, ear-piercing, tattoo or acupuncture, which has not been carried out under sterile conditions or not been made with single-use needles? No Yes 4. During the last 4 months did you have any contact to persons suffering from yellow fever, hepatitis or tuberculosis e.g. within your homely environment? No Yes 5. During the last 4 months did you have any contact with blood of another person e.g. via an open wound, via the mucous membrane (also eye) or via a lesion resulting from an instrument (e.g. injection needle)? No Yes 6. Have you ever been diagnosed with HIV, hepatitis B/C, AIDS or HTLV I/II? No Yes 7. Do you or your partner belong to a risk group of persons* (*see end of table) with a higher risk of HIV-/hepatitis infection, or did you or your partner have any sexual contact with a person belonging to such a risk-group during the last 4 months? No Yes 8. Are you under arrest or have you been released from prison in the last 4 months? No Yes 9. During the last 4 months did you or your partner have any sexual contact to persons of countries of sub-saharan Africa, the Caribbean, Southeast Asia or South America? No Yes 10. During the last 12 months did you receive blood, blood products or serum of animal origin? No Yes 11. Did you ever receive a transplant of human origin (e.g. stem cell donation, ovum or sperm donation) or animal origin (e. g. xenotransplant)? No Yes 12. During the last 4 months did you have any operation, endoscopy, biopsy, catheter application, accident? If so: Specify? Date: No Yes 13. During the last week did you have a smaller surgical intervention or tooth extraction? If so: Specify? No Yes 14. At present do you have any open wound, abscess or skin infection? If so: Specify? No Yes 15. Had or have you been addicted to drugs, alcohol or medicines? No Yes Anlage 11 zur SOP-Nr.: CB-05-01-01-17, gültig ab 01.06.2015, Seite 1 von 3
16. In the last 6 months have you been in a foreign country? 17. Are you born, have you grown up or did you stay ever longer than 6 months in an endemic region of Malaria? 18. During the last 6 months did you stay in an epidemic region of Malaria? If so: Where? Did you take drugs? If so, specify? No Yes 19. Did you or a relative suffer a transmissible spongiform encephalopathy (TSE), e. g. Creutzfeld-Jakob disease, Creutzfeld-Jakob disease or has there been a suspicion for a TSE? No Yes 20. Do or did you suffer from cancer, tumors, heart disease, vascular disease, hypertension (treated with drugs), allergy, tuberculosis, salmonella infections being a convalescent carrier (typhus, paratyphoid fever), borreliosis, toxoplasmosis, tropical diseases (malaria, epidemic typhus, babesiosis, trypanosomiasis, trypanosomiasis, leishmaniosis, ularemia,leprosy, brucellosis, relapsing fever, rickettsioses, melioidosis, etc.), venereal diseases (clap, syphilis, ulcus molle, lymphopatia venereal, etc.)? 21. Did you or do you suffer from diseases referring to blood, lymph nodes, nerves (e. g. spasms), kidneys, thyroid gland, lungs or bronchia, bones (e. g. osteomyelitis), liver, gastrointestinal disease? 22. Do you suffer from a autoimmune disorder or metabolic disease as e. g. diabetes? If so: what and since when? Do you need pharmaceuticals? No Yes, specify No Yes 23. Did you have any severe complications during pregnancy or are there any indications for malformations or chromosomal aberrations or severe diseases of the unborn baby? No Yes 24. Did you have during pregnancy or do you have at the moment acute infections? 25. Did you or do you have a hepatitis during pregnancy? 26. During the last 12 months: NO symptoms or signs at all thrombosis tumescence lymph nodes skin alterations seizures/faints cough Please comment every question marked circulatory disorders cardiac pain fever weight loss night sweat gastrointestinal disorders coagulopathy unusual bleeding nephritis / cystitis Yes! (If necessary indicated type, time, drugs taken): * Persons whose sexual practices involve a clearly increased risk, compared with the general population, of transmitting serious infectious diseases, such as HBV (Hepatitis B Virus), HCV (Hepatitis C Virus) or HIV, through blood. These include: heterosexual persons with high-risk sexual practices, sexual intercourse with frequently changing partners, men who have had sex with men (MSM), male and female prostitutes. Anlage 11 zur SOP-Nr.: CB-05-01-01-17, gültig ab 01.06.2015, Seite 2 von 3
MEDICAL HISTORY OF THE FAMILY (from the child s point of view) We need the information of the medical history of the family of the pregnant woman and the biological father. Please take into consideration that the relative relationships indicated below are seen from the child s point of view, this means you are the mother, siblings refers to siblings of the newborn, etc. Family origin of parents and grandparents: Mother Grandfather Grandmother Father Grandfather Grandmother 1. Have or had there been malignant tumors, leucemia or myeoloproliferative disorders in the closest family of the child (e.g. mother, father,siblings)? If so: Specify disorder and person No Yes 2. Are there any genetic disorders affecting the lymphatic or hematopoietic system (e.g. spherocytosis, Diamond-Blackfan, thalassemia, sickle cell anemia, elliptocytosis, Fanconi anemia, SCID, leucodystrophies, chronic granulomatosis, Glanzmann, Alport, hereditary thrombocytopenia, platelet storage disease, Tay-Sachs, ataxia teleangiectatica, other teleangiectasis, Fillipo, Gaucher, Hurler, Hunter), autoimmune diseases, muscular dystrophy, multiple sclerosis or severe hereditary skin diseases (e.g. neurofibromatosis), hereditary extreme light damage in extended family of the pregnant or the biological father (e.g. also including the child s grandparents)? If so: Specify disorder and person No Yes 3. Are there any chromosomal aberrations or other severe hereditary diseases known in the child s family? If so: Specify disorder and person No Yes BEFORE FINISHING, PLEASE CHECK AGAIN: Did you answer all questions? Did you shortly comment every question answered with "Yes"? Did you answer the questions true to the best of my knowledge? Did you indicate your personal data completely (name, date of birth, date, address, phone-no.)? Have you signed the informed consent? Do all medical and personal informations in this questionnaire refer to the date of delivery? Date Signature of mother Anlage 11 zur SOP-Nr.: CB-05-01-01-17, gültig ab 01.06.2015, Seite 3 von 3