Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation

Sponsor

National Marrow Donor Program (Other)

Overall Status

Completed

CT.gov ID

NCT00737516

Collaborator

(none)

3,621

Enrollment

Locations

Arm

141

Duration (Months)

190.6

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma Myelodysplastic Syndromes	Biological: HPC, Cord Blood	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

3621 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: single arm

HPC, Cord Blood

Biological: HPC, Cord Blood

Search for HLA compatible cord blood units using the NMDP registry

Outcome Measures

Primary Outcome Measures

Study safety and efficacy for treatment for malignant and non-malignant disorders [annually]

Secondary Outcome Measures

Study relationship between HLA disparity and survival [annually]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Pregnancy

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	StemCyte International Cord Blood Center	Covina	California	United States	91722
2	Children's Hospital of Orange County Cord Blood Bank	Orange	California	United States	92868
3	Ashley Ross Cord Blood Program	San Diego	California	United States	92103
4	University of Colorado Cord Blood Bank	Aurora	Colorado	United States	80218
5	Bonfils Cord Blood Service	Denver	Colorado	United States	80230
6	Lifeforce Cryobanks	Altamonte Springs	Florida	United States	32701
7	Gift of Life Marrow Foundation	Boca Raton	Florida	United States	33431
8	LifeCord	Gainesville	Florida	United States	32607
9	ITxM Cord Blood Services	Glenview	Illinois	United States	60025
10	J.P. McMarthy Cord Stem Cell Bank	Detroit	Michigan	United States	48201
11	Michigan Community Blood Centers	Grand Rapids	Michigan	United States	49503
12	St. Louis Cord Blood Bank	St. Louis	Missouri	United States	63110
13	CBS - New Jersey Cord Blood bank	Allendale	New Jersey	United States	07401
14	Coriell - New Jersey Cord Blood Bank	Camden	New Jersey	United States	08103
15	Carolinas Cord Blood Bank	Durham	North Carolina	United States	27710
16	Cleveland Cord Blood Center	Cleveland	Ohio	United States	44128
17	M.D. Anderson Cord Blood Bank	Houston	Texas	United States	77030
18	Texas Cord Blood Bank	San Antonio	Texas	United States	78201
19	Puget Sound Blood Center	Seattle	Washington	United States	98104