Trial Information

The Collection and Storage of Umbilical Cord Blood for Transplantation

The blood in an unborn baby's umbilical cord contains blood-making cells that could help
treat another person with a life-threatening disease. These cord blood cells may provide
cells for transplants given to patients with marrow diseases such as leukemia. These cord
blood transplants can be done when a patient's cell type (human leukocyte antigen, or HLA,
type) matches the cord blood type. 'Cord blood' is normally thrown away with the umbilical
cord and placenta after the baby is born.

Collection of the cord blood takes place after your new baby is born and the umbilical cord
has been clamped and cut in the normal way. The collection of cord blood takes place from
the part of the cord that is still connected to the placenta, not to your new baby. The cord
blood may be collected 'in-utero': after your baby is delivered but the placenta is still
inside the uterus, or it may be collected 'ex-utero': after the placenta is delivered. The
choice of which method of collection is performed will depend on the preference of your
obstetrician/midwife. Neither method puts you or your baby at any risk of injury. Once the
cord blood is drawn, it becomes the property of the MD Anderson Cord Blood Bank, and you
will not retain any residual interests or rights to this sample.

During the delivery of your baby, your obstetrician has your health and that of your newborn
baby as his or her main concern. If you agree to take part in this study, your doctor and/or
the Cord Blood Bank staff will try to collect the cord blood, but your doctor's main concern
will be the well being of you and your baby. Circumstances may arise which prevent the
collection of your cord blood.

The cord blood that is collected will be taken to the MD Anderson Cell Therapy Laboratory,
where it will be tested or sent out for testing to laboratories accredited for doing those
tests as described below.

Just like the donation of blood for transfusion, it is important that cord blood does not
carry any infections that can be passed on. When volunteers donate blood to a blood bank,
they are asked to fill out a confidential questionnaire about their risks for some
infections (like acquired immunodeficiency syndrome (AIDS) caused by the human
immunodeficiency virus (HIV), hepatitis, and/or malaria). You will be asked questions like
these in a questionnaire. This questionnaire will be completed within 48 hours of your baby
being born, and will take about 15 minutes to complete. You will also be asked some
questions about your family medical history, to check for the chance of an inherited disease
that could be passed on with the cord blood. This questionnaire is used for screening
purposes, and may result in your cord blood not being suitable for patient use. In which
case the cord blood may be used for research purposes or discarded.

You will be asked to sign a separate consent form called INFORMATION AND CONSENT TESTING FOR
ANTIBODY TO AIDS VIRUS. Your medical chart, and that of your infant, will be reviewed to
help determine whether you may have a disease which could be inherited and thus transmitted
with a cord blood unit to a transplant patient who receives it.

A blood sample (about 2 tablespoonfuls) will be drawn from you to test for infectious
diseases including HIV, human T cell Iymphotrophic virus (HTLV), Hepatitis B and C,
cytomegalovirus (CMV), West Nile Virus (WNV), Trypanosoma cruzi (T cruzi, a parasitic
organism that causes Chagas disease) and syphilis. The cord blood unit itself will also be
tested for HIV, HTLV, Hepatitis Band C, CMV, WNV, T. cruzi, syphilis, for bacterial and
fungal infection, and for the blood type (ABO/Rh). This testing will be performed at
accredited testing laboratories. Small samples of your blood and the cord blood (about 2
teaspoonfuls each) will also be frozen and stored separately to screen for diseases in the
future.

If you are delivering your baby in Texas, as per Texas state law, a blood sample will be
taken from your baby by the hospital staff and will be sent to the Department of State
Health Services to be tested for inherited diseases. One of these tests, 'Hemoglobinopathy
Screening', tests your child for diseases like sickle cell anemia and thalassemia. You will
be asked to sign a release form which will allow the Department of State Health Services to
release these Hemoglobinopathy screening results to the MD Anderson Cord Blood Bank. Since
such diseases may be passed on through transplant, your donated cord blood unit will not be
banked if positive results are received. The Department of State Health Services will notify
your physician of positive Hemoglobinopathy screening results.

In addition, the cord blood unit and sometimes the maternal blood sample will be tested for
its HLA type which will be used to identify matches with the transplant patient who needs
the cord blood. This testing will be performed at MD Anderson. A small sample of the cord
blood unit will be sent to the Stemcyte and City of Hope Laboratories in California for more
sophisticated typing to determine whether the cord blood unit might be useful in AIDS
patients.

Both your blood and your cord blood are tested for infections, because there are rare
instances where an infection could be found in the mother's blood and yet it has not been
found in the cord blood. It is also possible although uncommon, that an infection could be
found in the cord blood but not in the mother's blood. If the volume of your donated cord
blood is not large enough for banking, testing may not be performed.

All information you provide, as well as the identity of you and your new baby will be kept
as confidential as possible, to the fullest extent allowed by law. While the MD Anderson
Cord Blood Bank has to maintain a link between the cord blood unit and information
identifying you, multiple levels of security will protect this. When the information and
blood samples are collected, they will be given a unique sample number. Nobody except the
Principal Investigator and those designated by the Principal Investigator will have access
to any of your personal information. If your cord blood is released to another institution
for transplant, there will be no way to determine you were the donor as we keep your
identity anonymous. If your donated cord blood cells are used in a transplant, the recipient
of your cord blood cells will not be able to access any of your personal information.

At the time of donation, you will be asked to provide MD Anderson Cord Blood Bank an address
for you and your physician. If any abnormal or positive results are found during the testing
of your blood or the cord blood (such as HIV, HTLV, Hepatitis B, Hepatitis C, WNV, Chagas
and/or syphilis), the MD Anderson Cord Blood Bank will notify your physician using the
information you have provided to the Cord Blood Bank. As required by Texas law a confirmed
positive test for HIV/AIDS or syphilis from your blood or the cord blood will be reported to
the Texas Department of State Health Services. Additionally, the Houston Department of
Health and Human Services will be notified of any positive West Nile Virus results, and they
may contact you to conduct a confidential interview to help track community risk to WNV.

The Cord Blood Bank may also contact you directly, using the contact information you
provide, in order to obtain updated information about your child's health regarding
inherited disorders and/or communicable diseases, or to request additional information or
clarification of information contained in the Cord Blood Bank file. If you become aware of
any changes in your baby's health which may affect the suitability of the donated cord blood
unit for transplantation, it is important that you contact the Cord Blood Bank at
713-563-8000.

The cord blood will be tested and frozen. Cord blood units that meet clinical specifications
will be stored in the MD Anderson Cord Blood Bank, listed on the stem cell donor registries
and may be released to MD Anderson or other institutions in the US or around the world
following established criteria for bone marrow transplant donors, for a fee. These
institutions will use the cord blood for patients needing a bone marrow transplant. Any
fresh or stored cord blood units donated to the Cord Blood Bank that do not meet all the
clinical specifications (for example, if they are too small or have bacterial
contamination), and cannot be used for patients needing a bone marrow transplant, they may
be discarded or used for research or in studies to improve the cord blood banking
procedures, either at MD Anderson or at other institutions. Before your cord blood can be
used for research, the people doing the research must get specific approval from the
Institutional Review Board (IRB) of MD Anderson or the IRB of the institution where the
research will be performed. The IRB is a committee made up of doctors, researchers, and
members of the community. The IRB is responsible for protecting the participants involved in
research studies and making sure all research is done in a safe and ethical manner. All
research performed at MD Anderson, including research involving your cord blood from this
bank, must first be approved by the IRB.

The cord blood units will be used on a first come, first served basis. At the time of
donation, you will be given the address and phone number of the MD Anderson Cord Blood Bank.
In the unlikely event that you or another immediate family member develop a disease which
would require the use of your donated cord blood, it may be released to you on the same
basis that it would be provided to other qualifying patients, if it is still under the
control of the MD Anderson Cord Blood Bank and has not already been committed to a patient.
You should contact the MD Anderson Cord Blood Bank within one month of collection if you
wish to have your donated cord blood unit destroyed. If requested, the research staff will
destroy your cord blood unit if it has not been used for research, Cord Blood Bank
validation studies or quality control. After this one month period has passed, your cord
blood unit will be made available for patient use and you will be unable to request that it
be destroyed.

This is an investigational study.

Up to 250,000 women will take part in this study. All will be enrolled through MD Anderson.