Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation

Phase 2

Completed

• Conditions: Leukemia; Lymphoma; Myelodysplastic Syndromes

• Registration Number: NCT00737516
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2000-01
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-19
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-06
• Disposition First Submitted: 2013-06-04
• Disposition First Submitted QC: 2013-06-12
• Last Update Submitted: 2013-06-12
• Disposition First Posted: 2013-06-21
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3621

Inclusion Criteria

• Pregnancy

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Study safety and efficacy for treatment for malignant and non-malignant disorders	annually

Secondary Outcome Measures

Name	Time	Method
Study relationship between HLA disparity and survival	annually

Trial Locations

Locations (19)

StemCyte International Cord Blood Center; 🇺🇸 Covina, California, United States

Children's Hospital of Orange County Cord Blood Bank; 🇺🇸 Orange, California, United States

Ashley Ross Cord Blood Program; 🇺🇸 San Diego, California, United States

University of Colorado Cord Blood Bank; 🇺🇸 Aurora, Colorado, United States

Bonfils Cord Blood Service; 🇺🇸 Denver, Colorado, United States

Lifeforce Cryobanks; 🇺🇸 Altamonte Springs, Florida, United States

Gift of Life Marrow Foundation; 🇺🇸 Boca Raton, Florida, United States

LifeCord; 🇺🇸 Gainesville, Florida, United States

ITxM Cord Blood Services; 🇺🇸 Glenview, Illinois, United States

J.P. McMarthy Cord Stem Cell Bank; 🇺🇸 Detroit, Michigan, United States

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