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To ensure the quality of the cord blood collection, each collection site has National Cord Blood Program-trained staff.

Cord blood units for the New York Blood Center’s National Cord Blood Program are currently collected at eight collaborating hospitals. These hospitals were selected because they have large Obstetric Departments serving ethnically diverse populations. In each of these hospital sites, a team of NCBP-trained cord blood technicians and nurses work with the hospital’s Obstetricians, Obstetric service nurses and other staff. The NCBP team is responsible for collecting the cord blood and a mother’s blood sample and for obtaining their medical and family histories and consent for donation.

Cord blood can be donated only if the mother and infant are eligible. Cord Blood MUST NOT be collected when (but is not limited to) one or more of the following applies:

  1. The mother had an infectious disease during pregnancy that could have been transmitted to the infant before or during birth and might be present in the cord blood;
  2. The infant is affected by any one of several genetic or inherited diseases that might affect a patient if the cord blood was given as a transplant;
  3. There is a family history of a "transplantable" genetic disease that might be present in the baby, but for which there are currently no diagnostic tests;
  4. The pregnancy was the result of an egg (ovum) donation, or a sperm donation from a man other than the husband;
  5. The mother has history of leukemia or other cancer;
  6. The family has arranged to store the cord blood with a private cord blood bank.

NCBP-trained technicians collect cord blood from the delivered placenta.

After the baby is born, the umbilical cord is clamped and cut and the placenta is delivered a few minutes later. The Obstetrician or midwife places the placenta in a sterile container and passes it on to an NCBP technician. The technician takes the placenta to an adjacent, specially-equipped laboratory. She thoroughly cleans and disinfects the surface of the umbilical cord attached to the placenta. To collect the cord blood remaining in the umbilical vein and placenta, the technician uses a sterile blood collection bag set with attached tubing and needle and punctures the cleaned surface of the cord with the needle, to enter the umbilical vein. The cord blood drains through the tubing into the bag by gravity. Because we collect cord blood after the placenta is delivered and outside of the delivery room, collection does not interfere in any way with the care given to the mother and infant. The procedure is therefore, involves no significant risk.

Cord blood can be DONATED FOR TRANSPLANTATION-only if enough cells were collected.

Cord blood transplants are most successful when the patient receives a relatively large number of stem cells. The number of stem cells in cord blood is determined by the volume of blood that can be collected and the concentration of the nucleated blood cells present.  To optimize the usefulness of the cord blood units in our inventory, we now require a minimum of 1.1 billion nucleated cells for a cord blood unit to be considered for transplantation. This number of cells is usually found in 70-150 milliliters (about three to five ounces) of cord blood. We can obtain a collection with an adequate number of cells from 40% of normal deliveries.

The cord blood unit is given a unique ID number.

When the mother and infant are eligible to donate and the unit has enough cells, a unique identification (ID) number is assigned, using a pre-printed bar-coded label. Data forms and all specimen tubes get identical ID labels, both bar-coded and human-readable. To prevent mix-ups when several babies are delivered at the same time, NCBP staff attempt a new cord blood collection only after the previous collection and all its paperwork and tubes are completely labeled and identified (NCBP’s “one-at-a-time” rule). This is one of the reasons why, infrequently, we cannot collect cord blood from some deliveries.

Mother's consent is requested.

As required by the NCBP’s FDA IND exemption, the mother is asked to consent to donate the cord blood to the National Cord Blood Program for any patient who might need it in the future. If the mother does not want, or is not eligible to donate for clinical use in transplantation, she can either donate the cord blood for biomedical research or ask that her baby’s cord blood be discarded.

Interview and medical record review.

When the mother consents to donate, NCBP-trained staff obtain information from her own and her baby’s medical records. Staff also ask the mother questions about her past medical history, about this pregnancy and about her’s and father’s ethnic background and family history of genetic diseases. We ask about risks for certain infectious diseases that can be transmitted by blood or from mother to infant. All of this information helps the NCBP characterize the cord blood and assess possible risks of transmission of an infectious or genetic disease to a patient who might be given the cord blood in the future. The specific diseases and/or risk factors in our questionnaire are those required by current FDA regulations.

A blood sample is taken from the mother.

A sample of the mother’s blood is needed to test for infectious diseases that can be transmitted by blood transfusion and /or the placenta to the baby. The mother’s blood sample is preferably obtained in the course of routine blood sampling after delivering and is also tested for her HLA type.

The cord blood and mother's blood will be tested for certain infectious diseases.

The mother’s blood and cord blood samples are tested for infections with hepatitis type B and C viruses (HBV and HCV), human immune deficiency virus types I and II (HIV, the AIDS viruses), human T-lymphotropic viruses type I and II (HTLV), syphilis, West Nile Virus (WNV) and Chagas disease. The same tests are used routinely to screen regular volunteer blood donors. These, and the results of tests for genetic disease (see below) are done free of charge to the mother and results are sent to the mother’s Obstetrician and the baby’s Pediatrician.

The cord blood will be tested for certain genetic diseases.

The cord blood is tested for the common defects in hemoglobin (the oxygen carrying molecule in red blood cells), including sickle cell anemia and for certain others that may be required by a patient for whom a cord blood unit has been matched.

Samples are saved and may be used for further testing in the future.

Cord and mother’s blood samples are kept, frozen, and may be used in the future, even years after the baby’s birth. We must plan for the possibility that new tests for infectious or genetic diseases will be developed for which the cord blood must be tested in order to protect a transplant recipient from risk.

Confidentiality.

All cord blood units, the mother’s written consent and completed data forms are sent to the NYBC’s National Cord Blood Program for processing and data entry. To protect donor confidentiality, consent and data forms are kept in a locked file room, available only to authorized Program staff. Data is also entered into a secure computer database.

Qualification of Cord Blood Units for the NYBC's National Cord Blood Program Inventory.

A cord blood unit must meet all of the criteria (at a minimum) below to qualify for inclusion in the NCBP Search Inventory and be available for transplantation:

1. The unit contains 1.1 billion total nucleated cells (TNC) or more before processing. Note: units collected in the first few years of the Program may have had fewer TNC;

2. The mother has given consent for donation to the public bank (the unit can be used by any patient in need for a stem cell transplant);

3. The unit has been typed for HLA-A, -B and –DRB1 (A and B at low resolution and DRB1 at high resolution) and for the blood group antigens A, B and Rh:1 (D);

4. The unit had acceptable results for CD34+ cells and CFU (colony forming units). Note: CFU evaluation has not been performed in all units;

5. There is no bacterial contamination of the unit;

6. The infant has no identified risks of genetic or infectious disease that might be transmitted in the cord blood;

7. The unit and the mother’s blood are negative for infectious disease markers;

8. The cord blood unit was processed and frozen following the NCBP protocol validated to maintain nucleated cell viability.

9. A sample of cord blood is available in a segment of the tubing integral to the bag containing the cord blood unit, for future confirmatory HLA typing.

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Ramona Shih and her baby

Ramona Shih donated her baby's cord blood to the NCBP in September 2002. "It's an incredibly simple act that could have such profound consequences; it's like giving life twice."
 

Cord blood is an investigational product not licensed by the FDA.