Cord blood is a "biological" product and--pending FDA licensure of cord blood--the proper context for cord blood banking and for using cord blood in treating patients is under an FDA IND exemption. This is because, from a regulatory viewpoint, cord blood 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.
From the regulatory perspective, the donors of cord blood (the mothers who donate their newborn's cord blood) also are "human research subjects" and come under the same FDA and OHRP protections. For this reason, we collect 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.
To date, more than 33,000 mothers have donated their baby's cord blood to the NYBC's National Cord Blood Program. Our donors 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. [See: Why is cord blood important for ethnic minorities?].
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 approximately 6,000 cord blood transplants throughout the world thus far. In the United States, one half of all stem cell transplants from unrelated donors in children now use cord blood. In Japan, this is true for adults as well. Our Program has provided cord blood units for transplantation to over 2,000 recipients to date--approximately one third of all cord blood transplants from unrelated donors worldwide. Most have been affected by leukemia, lymphoma, severe aplastic anemia, other lethal diseases of the blood or immune system or certain inherited metabolic diseases [See: Patients & Outcomes for a listing of all diseases treated].
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 matching 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 have learned from the reports 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 a minor, with the family.
This Website attempts to provide accurate and timely information about cord blood transplants and public donation, as well as about technical aspects of our Program's operations. Patients and families considering a possible transplant can read about the potential advantages and disadvantages of cord blood transplantation in Cord Blood Q&A and in a Comparison between Bone Marrow & Cord Blood. Encouraging Patient Stories can be found in the Patients & Outcomes section. Website visitors can find out how the NCBP works in Program Overview. More technical information about cord blood collection and processing can be found in NCBP at Work.
Expectant parents can get useful information about donation from Cord Blood Donation. You can keep current with News & Articles. Use the new SiteMap to help navigate the site.
One of the unique features of the NCBP website is our Public Cord Blood Search program which allows anyone the on-line opportunity to obtain an "informal" preliminary count of possible matching CB units in the NCBP inventory at the time of your search. See the "Public NCBP Cord Blood Search" link at the top of this homepage. Detailed instructions will help guide you through the process.
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