New York Blood Center National Cord Blood Program
Umbilical cord blood donated to the New York Blood Center’s National Cord Blood Program is
collect, tested, processed, cryoprotected and frozen in liquid nitrogen for possible future
transplantation to anyone who needs it. The Program has operated under a FDA IND exemption
since 1996 and is licensed as a tissue bank by the New York State Department of Health.
Candidates for transplant are patients who disease requires bone marrow transplantation but
who do not have a suitable related bone marrow donor. Most patients are those with high
risk of refractory leukemia, lymphoma, myelodysplasia, severe aplastic anemia and certain
genetic hematologic, immunologic and metabolic diseases.
Patients are treated at bone marrow transplant centers in the United States and in other
countries with active marrow transplant programs. Because the NYBC Program operates under
IND, patients must sign an informed consent for cord blood transplantation.
Transplant centers report on the transplant procedure (including immediate complications)
and on transplant outcome at 3, 6 and 12 months post-transplant and annually thereafter.
Data report to the New York Blood Center includes information about the patient’s disease
and pre-transplant conditioning regimen and post-transplant endpoints, primarily myeloid and
platelet engraftment, transplant related mortality, overall survival, acute and chronic
graft vs. host disease, relapse and other post-transplant complications such as infectious
disease. The outcome data is used to assess safety and efficacy and will be used to apply
for a license from the FDA.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pablo Rubinstein, M.D.
New York Blood Center
United States: Food and Drug Administration
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