New York Blood Center's National Cord Blood Program is the first and largest public cord blood bank in the world. We collect, process, test and store cord blood units that are donated to us for any patient who might need a transplant. And, as of November 2011, the National Cord Blood Program is the first cord blood bank to have a licensed cord blood product, HEMACORD(TM) (hematopoietic progenitor cells, cord blood). (Press release: FDA, PR Newswire).
To date, over 60,000 mothers have donated their baby's cord blood to New York Blood Center's National Cord Blood Program. Donors have come from a wide variety of 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 transplant for nearly all patients.
Cord blood recipients include children and adult patients suffering from life-threatening illnesses who need a "stem cell" transplant from an unrelated donor to provide them with healthy hematopoietic cells. There have been more than 30,000 cord blood transplants throughout the world so far. In the United States, one half of all pediatric and one fifth of adult stem cell transplants from unrelated donors are now performed with cord blood. New York Blood Center's National Cord Blood Program has provided cord blood units for transplantation to over 4,500 recipients so far, about one sixth of all cord blood transplants from unrelated donors. Most patients have been affected by leukemia, lymphoma, severe aplastic anemia, and other lethal diseases of the blood or immune system or certain inherited metabolic diseases.
The Food and Drug Administration (FDA) 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 this status, 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. 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(TM), were approved on November 10th, 2011. This is the first time ever that the FDA has licensed a stem cell product.
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(TM) products are). The unlicensed cord blood units are considered "investigational" products. These cord blood units can be used for human transplantation, 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.
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.
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