Welcome to the New York Blood Center's National Cord Blood Program Website - an interactive, informational resource for patients, their families and caregivers, health care professionals, expectant parents and the general public.
NYBC's Howard P. Milstein Cord Blood Center (supported by the Howard and Abby Milstein Foundation) and its National Cord Blood Program (NCBP) is the world's first and largest single public cord blood bank. We collect, process, test and store cord blood that mothers donate to us for patients in need for a hematopoietic stem cell transplant. Our Program makes cord blood available - either as a product (HEMACORD®) licensed by U.S. Food and Drug Administration (FDA), or under an Investigational New Drug (IND) exemption from the FDA - for children and adults who face a life-threatening illness and need "stem cell" transplants from unrelated donors. NYBC's NCBP was also the first public cord blood bank in the world to receive NetCord-FACT accreditation (June 2003). Click here for more information on NetCord-FACT accreditation. The NetCord-FACT Accreditation was last renewed on February 9th, 2015.
The Food and Drug Administration granted the National Cord Blood Program an Investigational New Drug (IND) exemption in 1996, making us the first cord blood bank to obtain such an exemption. To achieve and maintain this status, we applied voluntarily, 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. As a result of the FDA requirement for a specific clinical protocol, we amended our “banking” IND by expanding it with a Clinical Protocol accepted by the FDA. We are currently increasing the number of participating Transplant Centers. A different and more detailed application was submitted to the FDA in January 2011 for licensure of our cord blood units and processes. The application and our product, HEMACORD®, were approved on November 10th, 2011. This is the first time ever that the FDA has licensed a stem cell product (Press release: FDA, PR Newswire). HEMACORD®, the First FDA-Licensed stem cell product, was awarded the prestigious “Best Biotechnology Product” Award by Prix Galien USA, in October 2014. The award recognizes “biomedical products that advance the human condition and which were approved by the U.S. Food and Drug Administration (FDA) during the past five years,” according to the Galien Foundation (Press release).
The FDA considers cord blood to be a "biological" product. Cord blood units that meet all the prescribed FDA cGMP criteria and process requirements can be licensed (as the HEMACORD® products are). Unlicensed cord blood units are considered "investigational" products, which can only be used for human transplantation under an active FDA IND (such as NCBP IND), but their use requires review by an Institutional Review Board (IRB) and particular patient and physician approval, which must be documented on IRB-approved informed consent forms.
From the regulatory perspective, the donors of cord blood (the mothers who donate their newborn's cord blood) and the patients who receive investigational cord blood transplants are "human research subjects" under FDA and Office for Human Research Protection (OHRP). For this reason, since 1996, we collect cord blood following protocols, policies and procedures submitted to the FDA and formally accepted by the Institutional Review Board (IRB) of the New York Blood Center as well as by the IRB of each of the hospitals that collaborate with us as collection centers.
To date, cord blood donations from more than 60,000 mothers have been made to the NYBC's National Cord Blood Program. Our donors come from all ethnic backgrounds. For example, approximately 20% of the donors are African-American (having at least one African-American parent). Asians represent approximately 8% of all donors and multi-race donors make up 13-15%. Donors of Hispanic ancestry represent 21%. This ethnic diversity has made it possible for patients of different ethnic backgrounds to find suitable matches, thereby improving access to hematopoietic transplantation. [See: See: Why is cord blood important for ethnic minorities?].
Cord blood from unrelated donors has been used as an alternative to bone marrow or mobilized stem cells as a source of hematopoietic stem cells for more than 20 years. There have been more than 35,000 cord blood transplants performed worldwide so far. In the United States, more than 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 over 5,300 cord blood units for transplantation, thus far (more than one seventh of all units transplanted from unrelated donors). Most patients were 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 thus far].
When considering a transplant, the transplant physician is responsible for assessing whether his/her patient needs a hematopoietic stem cell transplant and if so, for choosing the most appropriate source of those stem cells—cord blood, bone marrow or mobilized stem cells. When matched cord blood units from our bank are being considered for a transplant, we work with the transplant physician to help select the most appropriate unit (based, in part, on what we have learned from the reports transplant centers send 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.
The National Cord Blood Program also provides cord blood units for research: units that will not be used for transplantation are made available to many scientists and institutions for important basic research on cord blood stem and immune cells. For any questions or additional information, please contact us at email@example.com or firstname.lastname@example.org.
This Website attempts to provide accurate and timely information about cord blood transplants and public donations, as well as about technical aspects of our Program's operations. Patients and families considering a possible transplant must be told that other than cord blood units licensed by FDA, all units must be distributed as investigational products. They 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. You can use the new SiteMap to help navigate the site.