New York Blood Center National Cord Blood Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00212407
Recruitment Status : Terminated (Study NCT01656603 supersedes this study; FDA IND 6637)
First Posted : September 21, 2005
Last Update Posted : November 2, 2018
Information provided by (Responsible Party):
New York Blood Center

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.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Genetic Disease Severe Aplastic Anemia Myelodysplasia Biological: Umbilical Cord Blood Transplantation Early Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 4476 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Engraftment [ Time Frame: released prior to 12-1-2012 ]
  2. Treatment Related Mortality [ Time Frame: released prior to 12-1-2012 ]
  3. Survival [ Time Frame: released prior to 12-1-2012 ]

Secondary Outcome Measures :
  1. Graft vs. Host Disease [ Time Frame: released prior to 12-1-2012 ]
  2. Relapse [ Time Frame: released prior to 12-1-2012 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Candidates for bone marrow transplantation

Exclusion Criteria:

Information from the National Library of Medicine

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 identifier (NCT number): NCT00212407

United States, New York
New York Blood Center
New York, New York, United States, 10021
Sponsors and Collaborators
New York Blood Center
Principal Investigator: Pablo Rubinstein, M.D. New York Blood Center

Additional Information:
Responsible Party: New York Blood Center Identifier: NCT00212407     History of Changes
Other Study ID Numbers: 234
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018

Keywords provided by New York Blood Center:
Cord blood transplantation
bone marrow transplantation

Additional relevant MeSH terms:
Anemia, Aplastic
Genetic Diseases, Inborn
Myelodysplastic Syndromes
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions