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Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation
This study is currently recruiting participants.
Verified by National Marrow Donor Program, August 2008
First Received: August 15, 2008   Last Updated: August 18, 2008   History of Changes
Sponsor: National Marrow Donor Program
Information provided by: National Marrow Donor Program
ClinicalTrials.gov Identifier: NCT00737516
  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
Other Hematological Disorders
Metabolic Storage Diseases
Other: Search individual cord blood banks
Phase II

Study Type: Interventional
Study Design: Open Label, Uncontrolled, Single Group Assignment
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 ]

Estimated Enrollment: 400000
Study Start Date: January 2000
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single arm: Experimental Other: Search individual cord blood banks
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 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 Recruiting
Covina, California, United States, 91722
Contact: Robert Chow, M.D., A.M.     626-646-2488        
Principal Investigator: Lawrence Petz, M.D.            
Children's Hospital of Orange County Cord Blood Bank Recruiting
Orange, California, United States, 92868
Contact: Azita Nourani, M.S.     714-289-4154        
Principal Investigator: Leonard Sender, M.D.            
Ashley Ross Cord Blood Program Active, not recruiting
San Diego, California, United States, 92103
United States, Colorado
University of Colorado Cord Blood Bank Recruiting
Aurora, Colorado, United States, 80218
Contact: Stephanie Warnell, B.S., CHS     303-724-1317        
Principal Investigator: Brian Freed, Ph.D., DABHI            
Bonfils Cord Blood Service Active, not recruiting
Denver, Colorado, United States, 80230
United States, Florida
Cryobanks, International, Inc. Recruiting
Altamonte Springs, Florida, United States, 32701
Contact: Donald Hudspeth     407-834-8333        
Principal Investigator: John R Edwards, M.D.            
LifeCord Recruiting
Gainesville, Florida, United States, 32607
Contact: Katherine S. Tanner, M.S.W.     352-224-1737        
Principal Investigator: John R Wingard, M.D.            
Gift of Life Marrow Foundation Recruiting
Boca Raton, Florida, United States, 33431
Contact: Jay Feinberg, B.A., Lh.D.     800-962-7769        
Principal Investigator: Michael W Schuster, M.D.            
United States, Illinois
ITxM Cord Blood Services Recruiting
Glenview, Illinois, United States, 60025
Contact: Angela Sorensen, RN, BSN     800-486-0680 ext 7965        
Principal Investigator: Joseph E Kiss, M.D.            
United States, Michigan
J.P. McMarthy Cord Stem Cell Bank Recruiting
Detroit, Michigan, United States, 48201
Contact: Suanne Dorr, MBA, MT, SC     313-576-8863        
Principal Investigator: Voravit Ratanatharathorn, M.D., FACP            
United States, Missouri
St. Louis Cord Blood Bank Recruiting
St. Louis, Missouri, United States, 63110
Contact: Donna M Regan, MT(ASCP)SBB     314-268-2787        
Principal Investigator: William Ferguson, M.D.            
United States, New Jersey
CBS - New Jersey Cord Blood bank Recruiting
Allendale, New Jersey, United States, 07401
Contact: Roger Mrowiec, Ph.D.     201-251-3964        
Principal Investigator: David E Sharp, M.D.            
Coriell - New Jersey Cord Blood Bank Recruiting
Camden, New Jersey, United States, 08103
Contact: Donna Altamuro     856-757-9695        
Principal Investigator: David E Sharp, M.D.            
United States, North Carolina
Carolinas Cord Blood Bank Recruiting
Durham, North Carolina, United States, 27710
Contact: Lettie Moore, A.S.     919-668-1100        
Principal Investigator: Joanne Kurtzberg, M.D.            
United States, Texas
M.D. Anderson Cord Blood Bank Recruiting
Houston, Texas, United States, 77030
Contact: Tara K Sadeghi     713-792-4605        
Principal Investigator: Elizabeth J Shpall, M.D.            
Texas Cord Blood Bank Recruiting
San Antonio, Texas, United States, 78201
Contact: Mary Beth Fisk, AMT,CTBS,CQA     800-292-5534 ext 1865        
Principal Investigator: Rachel-Louise Beddard, M.D.            
United States, Washington
Puget Sound Blood Center Recruiting
Seattle, Washington, United States, 98104
Contact: Douglas D Mora     206-292-2535        
Sub-Investigator: Thomas H Price, M.D.            
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 Center for Cord Blood ( John P. Miller, M.D., Ph.D., Vice President & Sr. Medical Director Donor Medical Services )
Study ID Numbers: T00004
Study First Received: August 15, 2008
Last Updated: August 18, 2008
ClinicalTrials.gov Identifier: NCT00737516     History of Changes
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:
Disease
Neoplasms by Histologic Type
Immunoproliferative Disorders
Precancerous Conditions
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Leukemia
Lymphatic Diseases
Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Lymphoproliferative Disorders
Bone Marrow Diseases
Lymphoma

ClinicalTrials.gov processed this record on November 20, 2009