New York Blood Center National Cord Blood Program

This study is currently recruiting participants.
Verified April 2014 by New York Blood Center
Sponsor:
Information provided by (Responsible Party):
New York Blood Center
ClinicalTrials.gov Identifier:
NCT00212407
First received: September 13, 2005
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Leukemia
Lymphoma
Genetic Disease
Severe Aplastic Anemia
Myelodysplasia
Biological: Umbilical Cord Blood Transplantation
Phase 0

Study Type: Interventional
Study Design: 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 [ Time Frame: released prior to 12-1-2012 ] [ Designated as safety issue: No ]
  • Treatment Related Mortality [ Time Frame: released prior to 12-1-2012 ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: released prior to 12-1-2012 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Graft vs. Host Disease [ Time Frame: released prior to 12-1-2012 ] [ Designated as safety issue: Yes ]
  • Relapse [ Time Frame: released prior to 12-1-2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5000
Study Start Date: February 1993
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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: Andromachi Scaradavou, M.D. 718-706-5207 ascaradavou@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: Andromachi Scaradavou, M.D.    708-706-5207    ascaradavou@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

Responsible Party: New York Blood Center
ClinicalTrials.gov Identifier: NCT00212407     History of Changes
Other Study ID Numbers: 234
Study First Received: September 13, 2005
Last Updated: April 7, 2014
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:
Genetic Diseases, Inborn
Anemia
Anemia, Aplastic
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 April 16, 2014