Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Marrow Donor Program
ClinicalTrials.gov Identifier:
NCT00737516
First received: August 15, 2008
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Leukemia
Lymphoma
Myelodysplastic Syndromes
Biological: HPC, Cord Blood
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Centralized Cord Blood Registry to Facilitate Allogeneic, Unrelated Donor Umbilical Cord Blood Transplantation

Resource links provided by NLM:


Further study details as provided by National Marrow Donor Program:

Primary Outcome Measures:
  • Study safety and efficacy for treatment for malignant and non-malignant disorders [ Time Frame: annually ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Study relationship between HLA disparity and survival [ Time Frame: annually ] [ Designated as safety issue: Yes ]

Enrollment: 3621
Study Start Date: January 2000
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm
HPC, Cord Blood
Biological: HPC, Cord Blood
Search for HLA compatible cord blood units using the NMDP registry

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnancy

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737516

Locations
United States, California
StemCyte International Cord Blood Center
Covina, California, United States, 91722
Children's Hospital of Orange County Cord Blood Bank
Orange, California, United States, 92868
Ashley Ross Cord Blood Program
San Diego, California, United States, 92103
United States, Colorado
University of Colorado Cord Blood Bank
Aurora, Colorado, United States, 80218
Bonfils Cord Blood Service
Denver, Colorado, United States, 80230
United States, Florida
Lifeforce Cryobanks
Altamonte Springs, Florida, United States, 32701
Gift of Life Marrow Foundation
Boca Raton, Florida, United States, 33431
LifeCord
Gainesville, Florida, United States, 32607
United States, Illinois
ITxM Cord Blood Services
Glenview, Illinois, United States, 60025
United States, Michigan
J.P. McMarthy Cord Stem Cell Bank
Detroit, Michigan, United States, 48201
Michigan Community Blood Centers
Grand Rapids, Michigan, United States, 49503
United States, Missouri
St. Louis Cord Blood Bank
St. Louis, Missouri, United States, 63110
United States, New Jersey
CBS - New Jersey Cord Blood bank
Allendale, New Jersey, United States, 07401
Coriell - New Jersey Cord Blood Bank
Camden, New Jersey, United States, 08103
United States, North Carolina
Carolinas Cord Blood Bank
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Cord Blood Center
Cleveland, Ohio, United States, 44128
United States, Texas
M.D. Anderson Cord Blood Bank
Houston, Texas, United States, 77030
Texas Cord Blood Bank
San Antonio, Texas, United States, 78201
United States, Washington
Puget Sound Blood Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
National Marrow Donor Program
Investigators
Principal Investigator: John P Miller, M.D., Ph.D. National Marrow Donor Program
  More Information

No publications provided

Responsible Party: National Marrow Donor Program
ClinicalTrials.gov Identifier: NCT00737516     History of Changes
Other Study ID Numbers: T00004
Study First Received: August 15, 2008
Last Updated: June 12, 2013
Health Authority: United States: Food and Drug Administration

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:
Leukemia
Lymphoma
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on April 17, 2014