Cord blood donation is a painless and free gesture, helping others and saving lives. Cord blood, a bond for life.

Transcription

1 Cord blood donation is a painless and free gesture, helping others and saving lives. Cord blood, a bond for life.

2 What is cord blood? Cord blood (or placental blood) is the blood that remains in the placenta and umbilical cord after the birth of your child. During pregnancy, this blood is vital for your baby, but after birth the blood has no purpose. In most cases, it is then destroyed. What is its therapeutic value? Bone marrow transplants can now save the lives of patients with blood diseases or cancers. Unfortunately, many patients cannot have this treatment due to the lack of suitable donors. Cord blood can be used to treat these patients because it contains stem cells similar to those in the bone marrow capable of reconstituting the blood system. Once collected, cord blood can be frozen, stored and made available to patients requiring a transplant. We offer you the opportunity to donate your cord blood to the French Placental Cord Blood Network. This donation can offer a real chance of treatment for patients awaiting a transplant. Special case If someone in your family suffers from an illness requiring a transplant, the doctor in charge may require the collection and preservation of cord blood, which will then be reserved for family use. Consent Donating cord blood is a gesture, which is freely made, anonymous and free of charge. This donation will only be possible with your signed consent, and if you complete a prenatal medical questionnaire with questions about you and your family. The truthfulness of your answers will be crucial to ensuring the safety of the patient receiving the cord blood unit collected when you give birth. Your decision on whether or not to donate cord blood will not in any way affect the quality of care you and your child will receive. Collection The cord blood is collected within minutes after birth when the umbilical cord has been cut and the placenta is still in the womb. This collection does not affect traditional delivery procedures. It is painless and poses no risk to you or your child. It may not be possible to collect the cord blood if the midwives need to perform priority medical procedures.

3 After the collection The cord blood unit is transported to a cord blood bank. If it meets the biological criteria determined by the French Placental Cord Blood Network (sufficient volume and number of cells), further tests will be carried out on samples of your blood collected after giving birth (HIV, hepatitis B and C, syphilis, HTLV, CMV, EBV, toxoplasmosis). If these tests show no abnormality, the cord blood unit can be stored in liquid nitrogen with your blood samples in order to perform, if necessary, further tests. Two months later Two months after giving birth you will be contacted to check that there are no contraindications with you and your child. Health record A label will be affixed to your child s health record, stating that his cord blood was collected for an allogeneic transplant, i.e. where the transplant donor and recipient are two different people. The label will enable your doctor to notify the French Biomedicine Agency if required. Anonymity A number guaranteeing donor anonymity will be allocated to the unit of cord blood so that it can be registered on the National Register centralising transplant applications. Each transplant is then selected based on its degree of compatibility with the recipient and its cellular abundance. The bank may contact you at any time and you will be kept informed by mail of the fate of the donated cord blood which you have consented to.

4 Donation for scientific research If your donation does not meet the criteria determined by the French Placental Cord Blood Network, the cord blood may be destroyed according to validated procedures. Alternatively, the cord blood may be used for scientific research, in strict compliance with current regulations. Commercial cord blood banks are prohibited in France Commercial blood banks enable couples to preserve the cord blood, in return for payment, for future use reserved for the donor himself ( autologous transplant). Currently, there is no scientific basis to this approach ( No commercial cord blood bank is permitted in France by the health authorities. The French Placental Cord Blood Network: authorised banks and maternity clinics Only banks and maternity clinics that are part of the French Placental Cord Blood Network are approved by health authorities to coordinate the collection, preparation and storage of units of cord blood to make them available at any time to any patient. By using anonymous and free donations, this organisation guarantees the traceability and quality of technical procedures as well as equal access to treatment for the population. Individual data protection All information collected about you and your family will be treated as confidential, as recommended by the French National Commission for Information Technology and Civil Liberties (CNIL). The donation of cord blood will be kept anonymous by the bank to meet ethical standards for transplants.

5 CONSENT FORM Key figures Today, the Foundation has become one of the leading national organisations in the collection of placental stem cells in France with: - around 300 voluntary obstetricians and midwifes, specially trained in good practices; - a network of around ten maternity clinics authorised to carry out these collections; - Several thousand collections carried out with one of the best conformity rates in France.

6 SIREN Photographers: Benoit Rajau, Gil Lefauconnier and Thierry Cron - Crédit Photos: Fotolia

7 CONSENT FOR THE COLLECTION, ANALYSIS AND USE OF A CORD BLOOD DONATION Part 1: collection of cord blood I consent voluntarily and without payment to this donation at the end of this pregnancy and grant this donation to the French Placental Cord Blood Network in order for it to be made available to patients for medical benefit. I have read and understood all the information on the donation of cord blood and its use contained in the information leaflet that was given to me; a doctor or midwife has answered all my questions. My consent does not obligate the maternity hospital to collect cord blood if it considers that circumstances do not permit it. Finally, I reserve the right to withdraw this consent until the birth of my child, without giving reasons and without prejudice of any kind. Part 2: medical questionnaire and laboratory tests performed I agree to answer truthfully the questions I am asked in a prenatal and postnatal medical questionnaire on my medical history and that of my family. I agree that the donation will be recorded on my child s health record, after analysis of his/her medical file. I agree that the tests required or recommended by the regulations, including determination of my tissue typing, may be carried out and that my blood may be collected for this reason at the time of giving birth. In the event of an anomaly, or at my request, I will be informed of the outcome of these tests. I agree that these same tests may be performed on cord blood collected, together with the determination of tissue typing, which is essential in assessing compatibility between the cord blood and the patient requiring a transplant. I agree that samples of my blood and cord blood may be preserved long term if further tests are needed, according to current regulations. I understand that this donation is and must remain anonymous and it will not be possible to find out the recipient of the transplant. Nevertheless, I accept the principle that I may be contacted for further information by the cord blood bank associated with the establishment in which I gave birth. Part 3: future of samples suitable for therapeutic use I entrust with no time limit the responsibility of this donation to the French Placental Cord Blood Network so that this sample is stored until it can be made available and used for therapeutic purposes at any time, for any patient whose condition requires a transplant. I understand that this sample may not be available for intrafamilial use at a later date, if it has been used for a patient. Part 4: future of samples not suitable for therapeutic use In the event that the sample does not meet compliance criteria, I agree that it can be destroyed according to procedures in force in the cord blood bank or used in research and development while complying with the anonymity and confidentiality of data and as part of : - Validation studies of quality control methods or techniques or biomonitoring studies. - Medical research programmes approved ethically in collaboration with recognised research, public, hospital or university organisations (Decree of 10 August 2007). Part 5: protection of personal information I agree that the results of laboratory tests performed as part of the donation of cord blood and information about me and my immediate family and my child, collected both during the prenatal and postnatal questionnaire, may be kept on computer by the French cord blood bank. Data on characteristics of the cord blood unit donated including the results of laboratory tests will be forwarded anonymously to the French Biomedicine Agency for the registration of donations on the National Register centralising transplant applications and where appropriate may be transmitted in accordance with the provisions of the French Data Protection Act to allow its use for non-therapeutic purposes. Pursuant to amended Law No of 6 January 1978 relating to data protection, I have a right to access, and, in the event of any inaccuracies, correct or delete these data by contacting the head of the cord blood bank. Married name: First name: Date: / / Maiden name: Date of birth: / / Signature: Name and signature of the person collecting the consent and having verified the mother s identity: FGDS_Consentement don SP_v2 janvier 2011_en_clean / Validation RFSP: 17 March 2010 / + complying with the data protection law + decree White sheet for the patient Yellow sheet for the maternity hospital Green sheet for the Cord Blood Bank

8 PLACENTAL BLOOD DONATION MEDICAL QUESTIONNAIRE The greyed out areas of the questionnaire are to be completed by the mother. Non-greyed out areas of the questionnaire are to be completed by the mother accompanied by a healthcare professional. IDENTIFICATION OF THE MOTHER (DONOR) Last name:... First name:... Date of birth:... Address: Home telephone no.:... Mobile telephone no.:... Placental blood barcodes no. (reserved for the Placental Blood Bank) ... MATERNAL MEDICAL HISTORY Do you have or have you had during your life: Auto-immune disease immunodeficiency no yes... Severe allergy no yes... Cancer no yes... Blood diseases (even minor) no yes... Coagulation disorders no yes... Treated endocrine diseases no yes... (Diabetes hyper/hypothyroidism, etc.) Heart disease no yes... Treated hypertension no yes... Kidney or urinary diseases no yes... Lung diseases no yes... Neurological diseases no yes... (Neuro-degenerative diseases Creutzfeldt Jakob Disease) Epilepsy no yes... Antidepressant/neuroleptic treatment no yes... Gastrointestinal diseases no yes... Liver diseases no yes... Dermatological diseases no yes... Ophthalmic diseases no yes... ENT diseases no yes... Gynaecological diseases no yes... Occupational diseases no yes... 1

9 History or high-risk behaviour of the patient with respect to the HIV, Hepatitis B and C viruses In the past 6 months: Have you had a tattoo, ear, skin or body piercing done? no yes with instruments or needles used more than once? no yes Have you been in contact with human blood through an injection, a wound or discharge? no yes Have you had sex with someone with AIDS or who is HIV positive? no yes Have you had sex with a man who has had sex with another man in the past 5 years? no yes Have you changed your sexual partner? no yes Have you had treatment by injections, auriculotherapy, acupuncture, mesotherapy? no yes In the past 12 months: Have you been treated for a sexually transmitted disease? no yes During your life: Have you used a syringe to inject drugs or drug substances? no yes Have you ever accepted money or drugs in exchange for sex? no yes Have you had a positive test for syphilis, AIDS, hepatitis B or hepatitis C? no yes Risks with respect to unconventional transmissible agents Spent more than one year in total in the British Isles between 1980 and 1996 no yes Personal or family history of the Creutzfeldt Jakob Disease no yes Growth hormone treatment before 1989 no yes Human chorionic gonadotropin hormone treatment of hypophyseal origin before 1986 no yes Tissue or organ transplants from a donor no yes Neurosurgical operations no yes Risks associated with travel Infectious or parasitic diseases no yes Have you stayed or were you born in an area at risk of: Chagas Disease (South America) no yes date/duration/country:... West Nile Virus no yes date/duration/country:... Malaria, HTLV no yes date/duration/country:... Stay outside Europe no yes date/duration/country:... Blood donor no yes date of last donation:... History of blood transfusions no yes date:... Treatment by blood derivative drugs no yes date:... Hereditary genetic diseases in the family no yes 2

10 MATERNAL FAMILY HISTORY Were you adopted? no yes If yes, do you have medical information on the family? If no, this is a contraindication for placental blood donation Mother... Father... Collateral relatives... Blood disease (leukaemia myelodysplastic syndrome) of a family member If yes: relationship and disease:... PATERNAL MEDICAL HISTORY Unknown father no yes A lack of information about the father is a contraindication for placental blood donation Date of birth:... Birthplace (City French département country):... Illness requiring regular medical care no yes... Infectious or parasitic diseases no yes... Viral hepatitis no yes... Blood diseases no yes... Chronic treatment no yes... Urinary diseases no yes... Hereditary genetic disease no yes... If yes, has genetic research been done on the father? Blood donation no yes... PATERNAL FAMILY HISTORY Was he adopted? no yes If yes, does he have medical information about the family?... If no, this is a contraindication for placental blood donation Mother... Father... Collateral relatives... Blood disease (leukaemia myelodysplastic syndrome) of a family member If yes: relationship and disease: SIBLINGS MEDICAL HISTORY Year of birth... F M... Year of birth... F M... Year of birth... F M... Year of birth... F M... 3

11 CURRENT PREGNANCY DATA Date of last period / / / Pregnancy start date / / / Due date / / / 1 - Care Midwife... Doctor... Gestation... Parity... Blood group... Screening for irregular antibodies... Medically assisted procreation IVF... Artificial insemination During the pregnancy has there been an infection or an infectious syndrome? If yes, diagnosis:...treatment:...date: Treatment Treatment taken during the pregnancy:... Long-term treatment:... Treatment for gravidic hypertension no yes 3 - Ultrasound scan Term Result 4 - Other Not done Done Result Down s syndrome screening (HT 21) Amniocentesis Anomalies Karyotype Normal 5 - Other events CONCLUSION Medical questionnaire meets requirements does not meet requirements Signed written agreement given yes no Doctor s name and signature Date of examination Comments Midwife s name and signature 4