Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Myelodysplastic Syndromes Other Hematological Disorders Metabolic Storage Diseases |
Biological: Search individual cord blood banks |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Centralized Cord Blood Registry to Facilitate Allogeneic, Unrelated Donor Umbilical Cord Blood Transplantation |
- Study safety and efficacy for treatment for malignant and non-malignant disorders [ Time Frame: annually ] [ Designated as safety issue: Yes ]
- Study relationship between HLA disparity and survival [ Time Frame: annually ] [ Designated as safety issue: Yes ]
| Enrollment: | 3621 |
| Study Start Date: | January 2000 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: single arm |
Biological: Search individual cord blood banks
Search for HLA compatible cord blood units using the NMDP registry
|
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 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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Pregnancy
Exclusion Criteria:
-
Contacts and Locations| United States, California | |
| StemCyte International Cord Blood Center | |
| Covina, California, United States, 91722 | |
| Children's Hospital of Orange County Cord Blood Bank | |
| Orange, California, United States, 92868 | |
| Ashley Ross Cord Blood Program | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| University of Colorado Cord Blood Bank | |
| Aurora, Colorado, United States, 80218 | |
| Bonfils Cord Blood Service | |
| Denver, Colorado, United States, 80230 | |
| United States, Florida | |
| Lifeforce Cryobanks | |
| Altamonte Springs, Florida, United States, 32701 | |
| Gift of Life Marrow Foundation | |
| Boca Raton, Florida, United States, 33431 | |
| LifeCord | |
| Gainesville, Florida, United States, 32607 | |
| United States, Illinois | |
| ITxM Cord Blood Services | |
| Glenview, Illinois, United States, 60025 | |
| United States, Michigan | |
| J.P. McMarthy Cord Stem Cell Bank | |
| Detroit, Michigan, United States, 48201 | |
| Michigan Community Blood Centers | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Missouri | |
| St. Louis Cord Blood Bank | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| CBS - New Jersey Cord Blood bank | |
| Allendale, New Jersey, United States, 07401 | |
| Coriell - New Jersey Cord Blood Bank | |
| Camden, New Jersey, United States, 08103 | |
| United States, North Carolina | |
| Carolinas Cord Blood Bank | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Cord Blood Center | |
| Cleveland, Ohio, United States, 44128 | |
| United States, Texas | |
| M.D. Anderson Cord Blood Bank | |
| Houston, Texas, United States, 77030 | |
| Texas Cord Blood Bank | |
| San Antonio, Texas, United States, 78201 | |
| United States, Washington | |
| Puget Sound Blood Center | |
| Seattle, Washington, United States, 98104 | |
| Principal Investigator: | John P Miller, M.D., Ph.D. | National Marrow Donor Program |
More Information
No publications provided
| Responsible Party: | National Marrow Donor Program |
| ClinicalTrials.gov Identifier: | NCT00737516 History of Changes |
| Other Study ID Numbers: | T00004 |
| Study First Received: | August 15, 2008 |
| Last Updated: | May 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Marrow Donor Program:
|
Registry Unrelated Umbilical Cord Blood donor Hematopoietic Reconstitution Center for Cord Blood Bone Marrow Transplantation |
Additional relevant MeSH terms:
|
Hematologic Diseases Leukemia Lymphoma Myelodysplastic Syndromes Preleukemia Metabolic Diseases Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Precancerous Conditions |
ClinicalTrials.gov processed this record on June 13, 2013