New York Blood Center National Cord Blood Program

New York Blood Center National Cord Blood Program
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by New York Blood Center.   Recruitment status was  Recruiting

First Received on September 13, 2005.  
No Changes Posted
Sponsor: New York Blood Center
Information provided by: New York Blood Center
ClinicalTrials.gov Identifier: NCT00212407
  Purpose

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
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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: New York Blood Center National Cord Blood Program

Resource links provided by NLM:

Further study details as provided by New York Blood Center:

Primary Outcome Measures:

  • Engraftment
  • Treatment Related Mortality
  • Survival

Secondary Outcome Measures:

  • Graft vs. Host Disease
  • Relapse

Estimated Enrollment: 5000
Study Start Date: February 1993

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidates for bone marrow transplantation

Exclusion Criteria:

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212407

Contacts
Contact: Pablo Rubinstein, M.D. 212-570-3230 prubinstein@nybloodcenter.org
Contact: Cladd E Stevens, M.D. 3212-570-3230 cstevens@nybloodcenter.org

Locations
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.            
Sponsors and Collaborators
New York Blood Center
Investigators
Principal Investigator: Pablo Rubinstein, M.D. New York Blood Center
  More Information

Additional Information:

No publications provided

ClinicalTrials.gov Identifier: NCT00212407    
History of Changes
Other Study ID Numbers: 234
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by New York Blood Center:

Cord blood transplantation
bone marrow transplantation

Additional relevant MeSH terms:

Anemia
Anemia, Aplastic
Genetic Diseases, Inborn
Leukemia
Lymphoma
Myelodysplastic Syndromes
Preleukemia
Hematologic Diseases
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on August 21, 2012

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