New York Blood Center National Cord Blood Program

Study Overview
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Brief Summary
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Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstitution in patients who would be potential candidates for a bone marrow transplant from an unrelated marrow donor. The outcome of transplantation is obtained to assess cord blood myeloid and platelet engraftment, transplant related mortality, overall survival, graft vs. host disease and, for patients with leukemia, lymphoma or myelodysplasia, relapse.

Detailed Description
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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.

Official Title
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New York Blood Center National Cord Blood Program

Conditions
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Leukemia, Lymphoma, Genetic Disease, Severe Aplastic Anemia, Myelodysplasia

Intervention / Treatment
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* Biological: Umbilical Cord Blood Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates for bone marrow transplantation Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical cord blood unit(s) transplant<br>Transplantation of cryopreserved umbilical cord blood unit(s) | Biological: Umbilical Cord Blood Transplantation<br> <br> * Other names: One or more matched umbilical cord blood units for transplant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engraftment |  | released prior to 12-1-2012 | 
| Treatment Related Mortality |  | released prior to 12-1-2012 | 
| Survival |  | released prior to 12-1-2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft vs. Host Disease |  | released prior to 12-1-2012 | 
| Relapse |  | released prior to 12-1-2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cord blood transplantation, bone marrow transplantation