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Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation

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.
 
ClinicalTrials.gov Identifier: NCT00737516
Recruitment Status : Completed
First Posted : August 19, 2008
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
National Marrow Donor Program

Brief Summary:
The National Marrow Donor Program (NMDP) has established a system for registering, matching, and tracking unrelated donor cord blood units (CBUs) and transplant outcomes. Study subjects are donors who enroll through collaborating cord blood banks. This study creates uniform collection, screening, testing and storage requirements for cord blood units. The purpose of standardization is to improve efficiency in the selection of cord blood units for transplantation.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Myelodysplastic Syndromes Biological: HPC, Cord Blood Phase 2

Detailed Description:
The NMDP Cord Blood registry is organized as a network of member cord blood banks and transplant centers whose interactions are managed by the NMDP's Center for Cord Blood. Banks agree to comply with uniform collection, screening, testing and storage requirements. Upon approval of membership, cord blood banks submit detailed information on each stored CBU for registration into a proprietary computer system. A transplant center, working on behalf of potential recipients, submits search requests to the NMDP and receives electronic reports detailing potentially suitable CBUs. From these reports, the transplant center selects a CBU(s) for further testing, which includes at a minimum confirmation of the CBUs Human Leukocyte Antigen (HLA) typing data. Upon final selection of the desired CBU for transplantation, arrangements are made for timely shipment of the unit to the transplant center. Following transplantation, recipient outcome data are submitted by the transplant center for addition to the study database.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3621 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Centralized Cord Blood Registry to Facilitate Allogeneic, Unrelated Donor Umbilical Cord Blood Transplantation
Study Start Date : January 2000
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single arm
HPC, Cord Blood
Biological: HPC, Cord Blood
Search for HLA compatible cord blood units using the NMDP registry




Primary Outcome Measures :
  1. Study safety and efficacy for treatment for malignant and non-malignant disorders [ Time Frame: annually ]

Secondary Outcome Measures :
  1. Study relationship between HLA disparity and survival [ Time Frame: annually ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnancy

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 ClinicalTrials.gov identifier (NCT number): NCT00737516


Locations
Show Show 19 study locations
Sponsors and Collaborators
National Marrow Donor Program
Investigators
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Principal Investigator: John P Miller, M.D., Ph.D. National Marrow Donor Program
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Responsible Party: National Marrow Donor Program
ClinicalTrials.gov Identifier: NCT00737516    
Other Study ID Numbers: T00004
First Posted: August 19, 2008    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by National Marrow Donor Program:
Registry
Unrelated Umbilical Cord Blood donor
Hematopoietic Reconstitution
Center for Cord Blood
Bone Marrow Transplantation
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases