Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737516
• Other study ID #: T00004
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2008
• Last updated: June 12, 2013
• Start date: January 2000
• Est. completion date: October 2011

Study information

• Verified date: June 2013
• Source: National Marrow Donor Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3621
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnancy

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Biological:
• HPC, Cord Blood
Search for HLA compatible cord blood units using the NMDP registry

Locations

Country	Name	City	State
United States	CBS - New Jersey Cord Blood bank	Allendale	New Jersey
United States	Lifeforce Cryobanks	Altamonte Springs	Florida
United States	University of Colorado Cord Blood Bank	Aurora	Colorado
United States	Gift of Life Marrow Foundation	Boca Raton	Florida
United States	Coriell - New Jersey Cord Blood Bank	Camden	New Jersey
United States	Cleveland Cord Blood Center	Cleveland	Ohio
United States	StemCyte International Cord Blood Center	Covina	California
United States	Bonfils Cord Blood Service	Denver	Colorado
United States	J.P. McMarthy Cord Stem Cell Bank	Detroit	Michigan
United States	Carolinas Cord Blood Bank	Durham	North Carolina
United States	LifeCord	Gainesville	Florida
United States	ITxM Cord Blood Services	Glenview	Illinois
United States	Michigan Community Blood Centers	Grand Rapids	Michigan
United States	M.D. Anderson Cord Blood Bank	Houston	Texas
United States	Children's Hospital of Orange County Cord Blood Bank	Orange	California
United States	Texas Cord Blood Bank	San Antonio	Texas
United States	Ashley Ross Cord Blood Program	San Diego	California
United States	Puget Sound Blood Center	Seattle	Washington
United States	St. Louis Cord Blood Bank	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Marrow Donor Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study safety and efficacy for treatment for malignant and non-malignant disorders		annually	Yes
Secondary	Study relationship between HLA disparity and survival		annually	Yes