Clinical trial NCT00737516: Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation
Official title: A Centralized Cord Blood Registry to Facilitate Allogeneic, Unrelated Donor Umbilical Cord Blood Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Lymphoma
Myelodysplastic Syndromes
Keywords: Registry
Unrelated Umbilical Cord Blood donor
Hematopoietic Reconstitution
Center for Cord Blood
Bone Marrow Transplantation
Lead sponsor: National Marrow Donor Program
Sponsor class: OTHER
First posted: 2008-08-19
Enrollment: 3621
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: Inclusion Criteria:

* Pregnancy

Exclusion Criteria:

-

Primary outcomes:
measure: Study safety and efficacy for treatment for malignant and non-malignant disorders
timeFrame: annually
Secondary outcomes:
measure: Study relationship between HLA disparity and survival
timeFrame: annually
Other outcomes:
Locations:
city: Covina
country: United States
facility: StemCyte International Cord Blood Center
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County Cord Blood Bank
state: California
city: San Diego
country: United States
facility: Ashley Ross Cord Blood Program
state: California
city: Aurora
country: United States
facility: University of Colorado Cord Blood Bank
state: Colorado
city: Denver
country: United States
facility: Bonfils Cord Blood Service
state: Colorado
city: Altamonte Springs
country: United States
facility: Lifeforce Cryobanks
state: Florida
city: Boca Raton
country: United States
facility: Gift of Life Marrow Foundation
state: Florida
city: Gainesville
country: United States
facility: LifeCord
state: Florida
city: Glenview
country: United States
facility: ITxM Cord Blood Services
state: Illinois
city: Detroit
country: United States
facility: J.P. McMarthy Cord Stem Cell Bank
state: Michigan
city: Grand Rapids
country: United States
facility: Michigan Community Blood Centers
state: Michigan
city: St. Louis
country: United States
facility: St. Louis Cord Blood Bank
state: Missouri
city: Allendale
country: United States
facility: CBS - New Jersey Cord Blood bank
state: New Jersey
city: Camden
country: United States
facility: Coriell - New Jersey Cord Blood Bank
state: New Jersey
city: Durham
country: United States
facility: Carolinas Cord Blood Bank
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Cord Blood Center
state: Ohio
city: Houston
country: United States
facility: M.D. Anderson Cord Blood Bank
state: Texas
city: San Antonio
country: United States
facility: Texas Cord Blood Bank
state: Texas
city: Seattle
country: United States
facility: Puget Sound Blood Center
state: Washington
Study officials:
affiliation: National Marrow Donor Program
name: John P Miller, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: