CORD BLOOD DONATION. is free, painless, and can save lives.

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1 CORD BLOOD DONATION is free, painless, and can save lives.

2 What is cord blood? Cord blood is blood that remains in the placenta and umbilical cord after birth. During pregnancy, this blood is vital for your baby, but after birth the blood is generally considered expendable. In most cases it is destroyed. What is its therapeutic value? Cord blood contains stem cells similar to those found in bone marrow, which can be used to reconstitute the blood system. Once collected, cord blood can be frozen, stored and made available to a patient requiring a transplant. We offer you the opportunity to donate your cord blood to the French National Cord Blood Network. Your donation will give hope to patients waiting for a transplant, and a real chance for treatment. Special case If someone in your family suffers from an illness that requires a cord blood transplant, French law allows your doctor to request the preservation of your cord blood for use by your family. Consent Cord blood donations are made freely, anonymously, and free of charge. Any donation requires your signed consent. As part of this process, you will complete a prenatal medical questionnaire containing questions on you and your family. To guarantee the safety of the patient receiving the donated cord blood unit, your answers must be truthful. Your decision on whether or not to donate cord blood will have no effect on the quality of care you and your child receive. Collection Cord blood is collected minutes after birth, once the umbilical cord has been cut, but while the placenta is still in the womb. Cord blood collection does not affect the normal delivery procedure. It is painless and poses no risk to you or your child. In the event that special medical procedures are required, your midwife may decide not to collect your cord blood.

3 Health record A certificate will be attached to your child s health record stating that their cord blood was collected for an allogeneic transplantation, i.e. a transplantation where the donor and the recipient are two different people. The certificate will allow your doctor to notify the French Biomedicine Agency if required. After collection Your cord blood unit is transported to a bank that is a member of the French National Cord Blood Network. If the unit meets the biological criteria established by the network (sufficient volume and number of cells), further tests are carried out on your blood samples, collected after you gave birth (HIV, hepatitis B and C, syphilis, HTLV, CMV, EBV, and toxoplasmosis). If all the tests are positive, the cord blood unit is stored in liquid nitrogen along with your blood samples, in the event that further tests are necessary. Anonymity Each cord blood unit is assigned a number that guarantees your anonymity. It is then registered in the French national registry, which centralises all applications for transplantations. Transplants are chosen based on their level of compatibility with the recipient, and their quantity of cells. You may be contacted by the bank, which will inform you in any event by mail on how your donated cord blood was used. Two months later Before the cord blood bank can approve your donation, they need to see your child s health record two months after its birth. Your maternity clinic will tell you which documents are required. A sample cannot be safely administered to a patient without these documents.

4 The French National Cord Blood Network: accredited banks and maternity clinics Only banks and maternity clinics that belong to the French National Cord Blood Network are accredited by the health authorities to coordinate the collection, preparation and storage of cord blood units. The units are then made available to any patient at any time. Through anonymous, free donations, the network guarantees traceability, high technical standards, and equal access to treatment for everyone. Donate to scientific research If your donation does not meet the criteria established by the French National Cord Blood Network, your cord blood is either destroyed according to approved procedures, or used for scientific research in strict compliance with French regulations. Commercial blood banks are prohibited in France Commercial blood banks allow couples to store their cord blood, for a fee, for the future exclusive use of the donor (autologous transplant). However, there is no scientific basis for this approach (www.agence-biomedecine.fr). No commercial cord blood banks have been approved by the French health authorities. Furthermore, packaging and exporting of cord blood is an illegal practice punishable by law. Personal data protection All personal or family information collected is treated as confidential, as recommended by the French National Commission for Information Technology and Civil Liberties (CNIL). To comply with ethical transplantation standards, the banks ensure that cord blood donations remain anonymous.

5 CONSENT FORM The Générale de Santé Foundation runs a leading philanthropic initiative to collect cord blood stem cells in France. The initiative gathers: Close to 400 volunteer obstetricians and midwives trained in best practices Five maternity clinics accredited for cord blood collection Over 13,000 units collected since 2010 Over 100 transplant patients worldwide Over 1,500 units made available to researchers each year for the development of new treatments

6 This Prize is organised in partnership with the French Academy of Sciences, under the patronage of the French Ministry of Education and Research. sangdecordon.org 03/ SIREN Design: GAYA - Photos: Getty - Fotolia - Imp Gestion Graphic. Each year, the Générale de Santé Foundation awards the International Prize for Research in Cell Therapy and Regenerative Medicine. This prize rewards scientific excellence in the field of tissue regeneration.

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: Maiden name: First name: Date of birth: / / Date: / / 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-REVU.doc Validation RFSP: 17 March 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

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