What is cord blood?

Cord blood, also referred to as umbilical cord blood or placental blood, is blood that flows in the circulation of and provides sustenance to the developing fetus in the mother's womb. After the baby's birth, the residual blood in the umbilical cord and placenta (afterbirth) is often thrown away as biologic waste. This needlessly discarded, life-saving resource of untapped umbilical cord blood is a rich and convenient supply of stem cells.

What are stem cells?

Stem cells are immature cells that develop into more specialized cells such as blood cells, muscle, nerve and others. Stem cells were isolated from animal models in the mid 1960s. In 1974, the presence of hematopoietic stem cells in human umbilical cord blood was first reported. In 1983, human cord blood was suggested to be a transplantable source of stem cells.

What are the types and sources of stem cells?

Stem cells can be obtained from the following sources:

• Embryonic stem cells: these are stem cells obtained from very early embryos (pre-implantation embryos, also known as "spare" embryos and "substandard" embryos) that are owned by infertile couples and produced from in-vitro fertilization.
• Embryonic germ cells: these are stem cells that are harvested from aborted fetal tissue.
• Adult stem cells: an example of an adult stem cell is the hematopoietic stem cell. The moral and ethical issues associated with embryonic tissue and fetal tissue are not a consideration in adult stem cell research.

Hematopoietic stem cells are the progenitor cells of the blood components (red cells, white cells, platelets) and immune systems. These can be obtained from the bone marrow, circulating or peripheral blood and umbilical cord blood. These cells circulate freely in the fetal blood, and are believed to migrate shortly after birth into the bone marrow, where they actively multiply in unlimited amounts throughout childhood and adulthood. Hematopoietic stem cells have the capacity for self-renewal and are multipotential, i.e., have the ability to develop into different blood cells. These account for 1 of 2,000 marrow cells. Umbilical cord blood is not only a rich source of hematopoietic stem cells, but it has also been found to contain mesenchymal progenitor cells that give rise to marrow stroma, bone, cartilage, muscle and connective tissue.

What are the uses and functions of stem cells?

When a patient receives chemotherapy or undergoes radiation treatment, a person's mature normal cells, stem cells and abnormal cells are damaged. Stem cells transplants are performed to provide new stem cells from a healthy donor to replace the defective ones. The stem cells:

• can actively divide and produce new blood cells within 4-6 weeks and are used in the treatment of certain diseases, including some cancers and inherited diseases. The hematopoietic stem cells will stimulate regeneration of the blood components in the bone marrow damaged by very high doses of chemotherapy and/or radiation.
• correct diseases in which the marrow is diseased or does not function properly (e.g. immune deficiency, aplastic anemia, red cell aplasia, white cell disorders).
• produce enzymes that are defective in children with inherited or inborn errors of metabolism.
• produce other types of cells (glial cells and macrophages) that gradually travel to the brain, liver, and other organs.

What are some specific diseases treatable with stem cells?

At least 70 diseases have been treated with stem cells. These include cancers (leukemias, lymphomas, myelomas), blood disorders (thalassemias, sickle cell anemia, Fanconi's anemia), immune deficiency diseases, genetic diseases and others. StemCyte has now supplied cord blood units for over 40 different life-threatening diseases.

What is the difference between public and private cord blood banking?

Who can donate?

A legal adult female who meets the requirements for cord blood donation -- for example, no history of AIDS or hepatitis -- can donate. The ideal candidate is a healthy, disease-free woman with an uneventful pregnancy, uncomplicated delivery, an intact placenta free of gross abnormality, and a family history negative for genetic diseases. StemCyte will not collect cord blood for donation from multiple births (e.g., twin pregnancy), emergency Cesarean section for complicated pregnancy, and other high-risk conditions (eclampsia).

The baby, based on biologic and genetic considerations, is reasonably considered to be the donor and owner of the cord blood. The mother, acting on behalf of herself and her baby, is considered as the donor for purposes of informed consent.

Why should I consider donating?

You and your baby can give the precious gift of life to another child or adult in need by donating the stem cells.

How many opportunities do I have to donate?

For each pregnancy, there is only one opportunity to donate your baby's umbilical cord blood --- immediately following your child's birth.

How can the umbilical cord blood that I donate help others?

The umbilical cord blood that you donate contains numerous stem cells that can help in the treatment of certain diseases, including some cancers and inherited diseases.

Who can use this donated umbilical cord blood unit?

Any child or adult will have equitable access to the cord blood, provided that there is an appropriate medical indication and the unit is suitably matched and acceptable for transplantation. The decision to transplant is not the responsibility of StemCyte but that of a transplant physician.

How will my family benefit?

The allogeneic cord blood donation offers no direct benefit to you, your child, your child's other siblings, or your child's biologic father. However, should you, the child, his/her biologic siblings or biologic father ever need the donated umbilical cord blood, StemCyte will provide the unit free of charge. If the donated unit has already been used for transplantation, StemCyte will attempt to provide the next most compatible unit available in it's inventory.

How much does it cost to donate?

There is no charge if you are giving birth at one of our participating hospitals and meet all of the requirements there. Neither you nor your health insurance company will be charged for the collection of the umbilical cord blood in this instance.

Can you collect from the hospital where I will have my baby delivered?

StemCyte has affiliated hospitals and obstetricians that participate in our Umbilical Cord Blood Donation Program. If your hospital or obstetrician is not in our program, you can contact us for further information.

Who performs the collection?

A trained physician, nurse or healthcare professional performs the collection.

Will the collection interfere with the birthing process?

No. The collection occurs after the baby has been delivered. The health of the mother and the infant takes precedence over the collection process. Collection of umbilical cord blood shall not interfere and shall have no impact on obstetric practice or patient care. For example, StemCyte will make no recommendations regarding time of umbilical cord clamping. The umbilical cord blood will not be collected if it is determined by your delivery physician that such collection poses potential harm to your child. The collection will be canceled immediately if any significant maternal perinatal complications occur and/or fetal birth defect or genetic disease is detected.

How, when and where is the umbilical cord blood obtained?

The umbilical cord blood is collected after the baby has been delivered and the umbilical cord has been clamped and cut. The cord blood can then be obtained before or after the delivery of the placenta (afterbirth). In the postplacental method (ex-utero method), the trained personnel will collect the umbilical cord blood after the afterbirth has been taken out of the mother's womb. In the preplacental method (In-utero method), the physician/obstetrician collects the cord blood in the delivery unit while the placenta is still in the womb. The average blood volume collected is higher in the preplacental method. Using sterile techniques, the trained collection specialist inserts a sterile needle into the umbilical vein to allow drainage of the blood by gravity into a sterile container containing anticoagulant; this can be accomplished either through a closed system via a sterile bag or an open system using a syringe. The entire collection process averages 5 to 10 minutes. The collected unit will be transported to our processing center for further processing, testing and storage.

What are the risks?

There are no potential significant risks to donation because the umbilical cord is collected after the delivery of your baby and your placenta.

What is expected of me, if I agree to give consent to participate in the cord blood donation program?

Prior to your expected due date, preferably during the third trimester, we are requesting a valuable investment of your time, roughly estimated to be between 15 to 30 minutes, to answer personal information such as demographic data, health history, and family genetic history. As in whole blood donation, you may find some of the questions to be very personal and intrusive. This is to help us evaluate the suitability of the cord blood unit that will be collected from you and transplanted to a recipient. Your peripheral blood will also be obtained for testing purposes, within 48 hours of the placental delivery but preferably around the time of umbilical cord and placental blood collection.

What happens after the umbilical cord blood is collected?

The umbilical cord blood unit is processed and undergoes testing, including infectious disease testing, and if necessary, genetic disease testing. Thereafter, the cord blood unit deemed acceptable for transplantation is stored in liquid nitrogen until needed.

What tests are taken to ensure the safety of the umbilical cord blood unit?

Each collected CBU undergoes comprehensive testing to ensure the safety and viability of the stem cells. These include infectious disease testing for the AIDS virus (HIV), hepatitis, West Nile Virus, and HTLV I/II virus. Examples of other tests are performed on the unit include blood typing (ABO and Rh typing), HLA typing, fungal and bacterial cultures, and other tests to determine the viability of the unit (e.g., colony forming units or CFU assays and hematopoietic progenitor assays such as total nucleated cells and CD34). On occasion, genetic tests may also be performed when deemed necessary- for example if there is a family history. Additionally, the mother’s blood is tested for infectious diseases as described above, but is also tested for syphilis and cytomegalovirus.

You are encouraged to call StemCyte if you have any questions about these tests.

How long will the umbilical cord blood be in storage?

Until used for transplants, the cord blood unit will be stored at very low temperatures in storage freezers containing liquid nitrogen. The exact duration of time is unknown because the field of umbilical cord blood transplantation is new. Some studies have revealed that cryopreserved marrow cells have been stored for 15 years and have remained viable for many years. It is generally believed that cord blood stem cells may be held indefinitely, similar to other types of frozen tissue.

What are my other options?

You can refuse participation in the umbilical cord blood donation program, and the cord blood and stem cells will be thrown away.

Autologous donation (banking your child's own cord blood himself or herself) is a service offered by family or private cord blood banks which will collect, process and store your baby's umbilical cord blood for a fee. StemCyte offers private banking through our family bank, StemCyte Family. Please call 1-866-389-4659 or click here to visit our website at www.stemcytefamily.com.

When did cord blood transplantation start?

The first human cord blood transplant was reported in the medical literature in 1972. The physicians who performed the transplant stated that fetal blood was successfully utilized in establishing a hematopoietic transplant in a leukemic patient. Subsequently, through international collaboration, a successful transplant was reported for Fanconi anemia in 1989. The cord blood of an HLA-identical female sibling was transplanted to a 5-year-old male with the disorder. The stem cells engrafted and no graft-versus-host-disease (GVHD) occurred (see item 26 below for definition of GVHD).

It was recently reported in the New England Journal of Medicine that between 7 - 8,000 umbilical cord blood transplants have been performed since inception.

What is considered a match?

There is an increased chance of a successful stem cell transplant when there is close matching for HLA between the donor and recipient. HLA or Human Leukocyte antigens are present on the surface of white blood cells. A person inherits the HLA genes of both parents. Therefore, a close HLA match can more likely be found in a person's own family and from unrelated but ethnically or racially similar persons. A person has only 1 in 4 chances of finding an HLA match in a sibling. Finding a match is increased if the cord blood donor pool consists of larger number of ethnically and racially diverse people.

Will the recipient know who the donor is?

No. Records of the mother and baby are strictly confidential. The donor will also not be informed of the recipient identity.

How does cord blood transplantation compare with traditional bone marrow transplantation?

The potential advantages of umbilical cord blood include the following:

• Cord blood is easier to procure.
• Cord blood collection is a painless, non-invasive procedure that does not require general anesthesia.
• There is no potential risk to the baby. No potential maternal risk is associated with postplacental delivery.
• The infant donor is less likely to be infected with infectious pathogens such as cytomegalovirus, (CMV), and adenovirus.
• On the other hand, other infectious agents can be transmitted from the mother to the infant during the pregnancy or at the time of birth and may be present in the cord blood unit. The mother serves as a surrogate source of information of health and family history.
• There is shorter search for a matched cord blood donor.
• Cord blood does not have to match the recipient's tissue type as closely as that in a bone marrow transplant.
• As the number of cord blood units collected from ethnically diverse populations increase, the search for a match becomes easier. The underrepresented minority groups will have better chances of matching.
• The stored unit, if found suitable, becomes immediately available for transplantation.
• Greater concentration of early or immature progenitor cells is believed to be present in umbilical cord blood.
• The hematopoietic progenitor cells have been reported to be nearly 10x that of bone marrow.
• Overall cost of cryopreservation and storage is lower than a marrow donor search.
• Lower risk of (<10%) and less severe rejection after transplantation and less frequent hospitalization have been reported.
• GVHD is a complication of stem cell transplants whereby the grafted lymphocytes reject and attack the "foreign" recipient cells, hence resulting in serious, potentially fatal complications. Because the cord blood stem cells can tolerate differences between the donor and recipient, the incidence and severity of graft-versus-host disease, or GVHD are reduced.
• The transplanted cord blood stem cells are thought to be naive and more forgiving of a recipient's immune cells, hence better survival rate and improved quality of life are expected in cord blood transplant recipients.

The potential disadvantages of cord blood transplantation compared to traditional marrow transplant are as follows:

• The relatively lower volume of harvested stem cells makes the cord blood transplant more effective in children and smaller adults. However, the use of double (2) cord blood units for larger adults is growing which is removing this limitation.
• The technology (ex-vivo expansion) to increase the number of these stem cells is currently under investigation.
• Current studies have shown that engraftment period appears delayed.
• The explanation for the potentially slower and incomplete recovery rates of neutrophil and platelet production is unclear. Theories include the relatively lower volume of transplanted stem cells and possible effects of anticoagulation and cryopreservation.
• Currently, fewer cord blood units are stored compared to the millions of registered potential marrow donors.
• There is a need to find a different allogeneic donor if graft failure or relapse ensues.
• Only one collected cord blood unit is available for a transplant procedure.
• Potential of transference of genetic disease from an allogeneic donor to a recipient.
• Sickle cell disease and thalassemia are examples of inherited conditions that can be potentially transmitted to a stem cell recipient.
• The importance of genetic history and genetic disease testing cannot be overemphasized.