New York Blood Center National Cord Blood Program
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|ClinicalTrials.gov Identifier: NCT00212407|
Recruitment Status : Terminated (Study NCT01656603 supersedes this study; FDA IND 6637)
First Posted : September 21, 2005
Last Update Posted : November 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Genetic Disease Severe Aplastic Anemia Myelodysplasia||Biological: Umbilical Cord Blood Transplantation||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4476 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||New York Blood Center National Cord Blood Program|
|Study Start Date :||February 1993|
|Actual Primary Completion Date :||November 10, 2011|
|Actual Study Completion Date :||November 10, 2011|
Experimental: Umbilical cord blood unit(s) transplant
Transplantation of cryopreserved umbilical cord blood unit(s)
Biological: Umbilical Cord Blood Transplantation
Other Name: One or more matched umbilical cord blood units for transplant
- Engraftment [ Time Frame: released prior to 12-1-2012 ]
- Treatment Related Mortality [ Time Frame: released prior to 12-1-2012 ]
- Survival [ Time Frame: released prior to 12-1-2012 ]
- Graft vs. Host Disease [ Time Frame: released prior to 12-1-2012 ]
- Relapse [ Time Frame: released prior to 12-1-2012 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212407
|United States, New York|
|New York Blood Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Pablo Rubinstein, M.D.||New York Blood Center|