Brief Title
New York Blood Center National Cord Blood Program
Official Title
New York Blood Center National Cord Blood Program
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.
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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Engraftment
Secondary Outcome
Graft vs. Host Disease
Condition
Leukemia
Intervention
Umbilical Cord Blood Transplantation
Study Arms / Comparison Groups
Umbilical cord blood unit(s) transplant
Description: Transplantation of cryopreserved umbilical cord blood unit(s)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
4476
Start Date
February 1993
Completion Date
November 10, 2011
Primary Completion Date
November 10, 2011
Eligibility Criteria
Inclusion Criteria:
- Candidates for bone marrow transplantation
Exclusion Criteria:
-
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Pablo Rubinstein, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00212407
Organization ID
234
Responsible Party
Sponsor
Study Sponsor
New York Blood Center
Study Sponsor
Pablo Rubinstein, M.D., Principal Investigator, New York Blood Center
Verification Date
October 2018