Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation

June 12, 2013 updated by: National Marrow Donor Program

A Centralized Cord Blood Registry to Facilitate Allogeneic, Unrelated Donor Umbilical Cord Blood Transplantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3621

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnancy

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: single arm
HPC, Cord Blood
Biological: HPC, Cord Blood
Search for HLA compatible cord blood units using the NMDP registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study safety and efficacy for treatment for malignant and non-malignant disorders
Time Frame: annually
annually

Secondary Outcome Measures

Outcome Measure
Time Frame
Study relationship between HLA disparity and survival
Time Frame: annually
annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Marrow Donor Program

Investigators

  • Principal Investigator: John P Miller, M.D., Ph.D., National Marrow Donor Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 18, 2008

First Posted (ESTIMATE)

August 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 12, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T00004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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