To date, over 50,000 mothers have donated their baby's cord blood to New York Blood Center's National Cord Blood Program. Donors have come from all ethnic backgrounds: 20% are African-American, 21% Hispanic-American, 8% Asian-American and 48% Caucasian. Ethnic diversity has helped patients of all ethnic backgrounds to find suitable matches, providing equal access to all patients.

National Cord Blood Program obtained its IND exemption from the FDA in 1996, the first cord blood bank to do so. To obtain the IND, we submitted our policies and protocols to the FDA and have provided annual reports on our program and on the results of transplants using cord blood units from our bank.

Cord blood is a "biological" product and pending FDA licensure of cord blood, it is currently considered an experimental source of hematopoietic (blood-forming) stem cells. Patients who are given cord blood transplants, therefore, are considered "human research subjects" and are entitled to protections under pertinent FDA and U.S. Office for Human Research Protections (OHRP) rules. Under those rules, each Transplant Center, for example, must obtain approval from its own Institutional Review Board (IRB), must use cord blood under research protocols and is responsible for obtaining consent from their patients who will receive cord blood transplants and thereby become research subjects. Because of our IND, the Transplant Center must report to us on the outcome of each transplant and we, in turn, must report to the FDA. New York Blood Center collects cord blood following protocols, policies and procedures submitted to the FDA and formally accepted by the IRB of the New York Blood Center as well as the IRBs of each of the hospitals that collaborate with us as a collection center.

Despite its current official status as an experimental stem cell source, cord blood is now widely used as an alternative to bone marrow as a source of hematopoietic stem cells. There have been about 16,000 cord blood transplants throughout the world thus far, for example. In the United States, one half of all marrow transplants from unrelated donors in children now use cord blood. In Japan, this is true for adults as well. New York Blood Center's National Cord Blood Program has provided cord blood units for transplantation to over 3,500 recipients so far, more than one fourth of all cord blood transplants from unrelated donors. Most have been affected by leukemia, lymphoma, severe aplastic anemia, other lethal diseases of the blood or immune system or certain inherited metabolic diseases.

In considering a transplant, the transplant physician is responsible for assessing whether his or her patient needs a hematopoietic stem cell transplant and, if so, deciding on the most appropriate source of those stem cells--cord blood or bone marrow. When a cord blood unit from our bank is being considered for a transplant, we work with the transplant physician to help select the most appropriate unit (based on what we haved learned from the reports that transplant centers send back to us on their patients who have already received cord blood units from our Program). The physician, however, makes the final decision with the patient or, in the case of minors, with the minor's family.