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Sponsored by: |
New York Blood Center |
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Information provided by: | New York Blood Center |
ClinicalTrials.gov Identifier: | NCT00212407 |
Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstition 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.
Condition | Intervention |
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Leukemia Lymphoma Genetic Disease Severe Aplastic Anemia Myelodysplasia |
Procedure: Umbilical Cord Blood Hematopoietic Stem Cell Transplantation Procedure: Umbilical Cord Blood Transplantation |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | New York Blood Center National Cord Blood Program |
Estimated Enrollment: | 5000 |
Study Start Date: | February 1993 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
-
Contact: Pablo Rubinstein, M.D. | 212-570-3230 | prubinstein@nybloodcenter.org |
Contact: Cladd E Stevens, M.D. | 3212-570-3230 | cstevens@nybloodcenter.org |
United States, New York | |
New York Blood Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Pablo Rubinstein, M.D. 212-570-3230 prubinstein@nybloodcenter.org | |
Contact: Cladd E Stevens, M.D. 212-570-3230 cstevens@nybloodcenter.org | |
Principal Investigator: Pablo Rubinstein, M.D. |
Principal Investigator: | Pablo Rubinstein, M.D. | New York Blood Center |
Study ID Numbers: | 234 |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00212407 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Cord blood transplantation bone marrow transplantation |
Myelodysplastic syndromes Neural Tube Defects Immunoproliferative Disorders Precancerous Conditions Nervous System Malformations Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Anemia Leukemia |
Lymphatic Diseases Preleukemia Anemia, Aplastic Neural tube defect, folate-sensitive Aplastic anemia Congenital Abnormalities Bone Marrow Diseases Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Nervous System Diseases |