Brief Summary
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.
Brief Title
New York Blood Center National Cord Blood Program
Detailed Description
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Leukemia
Lymphoma
Genetic Disease
Severe Aplastic Anemia
Myelodysplasia
Eligibility Criteria
Inclusion Criteria:
* Candidates for bone marrow transplantation
Exclusion Criteria:
\-
* Candidates for bone marrow transplantation
Exclusion Criteria:
\-
Inclusion Criteria
Inclusion Criteria:
* Candidates for bone marrow transplantation
* Candidates for bone marrow transplantation
Gender
All
Gender Based
false
Keywords
Cord blood transplantation
bone marrow transplantation
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT00212407
Org Class
Other
Org Full Name
New York Blood Center
Org Study Id
234
Overall Status
Terminated
Phases
Early Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
New York Blood Center National Cord Blood Program
Primary Outcomes
Outcome Measure
Engraftment
Outcome Time Frame
released prior to 12-1-2012
Outcome Measure
Treatment Related Mortality
Outcome Time Frame
released prior to 12-1-2012
Outcome Measure
Survival
Outcome Time Frame
released prior to 12-1-2012
Secondary Outcomes
Outcome Time Frame
released prior to 12-1-2012
Outcome Measure
Graft vs. Host Disease
Outcome Time Frame
released prior to 12-1-2012
Outcome Measure
Relapse
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ashlesha Dayal
Investigator Email
adayal@montefiore.org
Investigator Phone
Categories Mesh Debug
Cancer --- LEUKEMIA
Blood & Bone Marrow Cancers --- LEUKEMIA
Blood & Bone Marrow Cancers --- ANEMIA, APLASTIC
Cancer --- NEOPLASMS
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- LYMPHATIC DISEASES
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
Blood Disorders --- ANEMIA
Blood & Bone Marrow Cancers --- ANEMIA
Blood & Bone Marrow Cancers --- BONE MARROW FAILURE DISORDERS
Blood & Bone Marrow Cancers --- BONE MARROW DISEASES
Blood & Bone Marrow Cancers --- MYELODYSPLASTIC SYNDROMES
MeSH Terms
LEUKEMIA
LYMPHOMA
GENETIC DISEASES, INBORN
ANEMIA, APLASTIC
ANEMIA, REFRACTORY, WITH EXCESS OF BLASTS
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
CONGENITAL, HEREDITARY, AND NEONATAL DISEASES AND ABNORMALITIES
ANEMIA
BONE MARROW FAILURE DISORDERS
BONE MARROW DISEASES
ANEMIA, REFRACTORY
MYELODYSPLASTIC SYNDROMES
CORD BLOOD STEM CELL TRANSPLANTATION
TRANSPLANTATION
STEM CELL TRANSPLANTATION
CELL TRANSPLANTATION
CELL- AND TISSUE-BASED THERAPY
BIOLOGICAL THERAPY
THERAPEUTICS
SURGICAL PROCEDURES, OPERATIVE