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| Sponsor: | National Marrow Donor Program |
|---|---|
| Information provided by: | National Marrow Donor Program |
| ClinicalTrials.gov Identifier: | NCT00737516 |
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 |
Other: Search individual cord blood banks |
Phase II |
| 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 |
| Estimated Enrollment: | 400000 |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: single arm |
Other: Search individual cord blood banks
Search for HLA compatible cord blood units using the NMDP registry
|
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:
Exclusion Criteria:
-
Contacts and Locations| United States, California | |
| StemCyte International Cord Blood Center | Recruiting |
| Covina, California, United States, 91722 | |
| Contact: Robert Chow, M.D., A.M. 626-646-2488 | |
| Principal Investigator: Lawrence Petz, M.D. | |
| Children's Hospital of Orange County Cord Blood Bank | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Azita Nourani, M.S. 714-289-4154 | |
| Principal Investigator: Leonard Sender, M.D. | |
| Ashley Ross Cord Blood Program | Active, not recruiting |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| University of Colorado Cord Blood Bank | Recruiting |
| Aurora, Colorado, United States, 80218 | |
| Contact: Stephanie Warnell, B.S., CHS 303-724-1317 | |
| Principal Investigator: Ralph R Quinones, M.D. | |
| Bonfils Cord Blood Service | Active, not recruiting |
| Denver, Colorado, United States, 80230 | |
| United States, Florida | |
| Lifeforce Cryobanks | Recruiting |
| Altamonte Springs, Florida, United States, 32701 | |
| Contact: Donald Hudspeth 407-834-8333 | |
| Principal Investigator: John R Edwards, M.D. | |
| Gift of Life Marrow Foundation | Recruiting |
| Boca Raton, Florida, United States, 33431 | |
| Contact: Jay Feinberg, B.A., Lh.D. 800-962-7769 | |
| Principal Investigator: Michael W Schuster, M.D. | |
| LifeCord | Recruiting |
| Gainesville, Florida, United States, 32607 | |
| Contact: Kristy M Unold, MT(ASCP)SBB 352-224-1756 | |
| Principal Investigator: John R Wingard, M.D. | |
| United States, Illinois | |
| ITxM Cord Blood Services | Recruiting |
| Glenview, Illinois, United States, 60025 | |
| Contact: Tony Donofrio, B.S. 847-299-7511 | |
| Principal Investigator: Joseph E Kiss, M.D. | |
| United States, Michigan | |
| J.P. McMarthy Cord Stem Cell Bank | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Suanne Dorr, MBA, MT, SC 313-576-8863 | |
| Principal Investigator: Voravit Ratanatharathorn, M.D., FACP | |
| Michigan Community Blood Centers | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Mary Burroughs 616-233-8598 | |
| Principal Investigator: Lee Ann Weitekamp, M.D. | |
| United States, Missouri | |
| St. Louis Cord Blood Bank | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Donna M Regan, MT(ASCP)SBB 314-268-2787 | |
| Principal Investigator: William V Miller, M.D. | |
| United States, New Jersey | |
| CBS - New Jersey Cord Blood bank | Recruiting |
| Allendale, New Jersey, United States, 07401 | |
| Contact: Roger Mrowiec, Ph.D. 201-251-3964 | |
| Principal Investigator: David E Sharp, M.D. | |
| Coriell - New Jersey Cord Blood Bank | Recruiting |
| Camden, New Jersey, United States, 08103 | |
| Contact: Donna Altamuro 856-757-9695 | |
| Principal Investigator: David E Sharp, M.D. | |
| United States, North Carolina | |
| Carolinas Cord Blood Bank | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Lettie Moore, A.S. 919-668-1100 | |
| Principal Investigator: Joanne Kurtzberg, M.D. | |
| United States, Ohio | |
| Cleveland Cord Blood Center | Recruiting |
| Cleveland, Ohio, United States, 44128 | |
| Contact: Steven Foster 216-378-3031 | |
| Principal Investigator: Mary Laughlin, M.D. | |
| United States, Texas | |
| M.D. Anderson Cord Blood Bank | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Tara K Sadeghi 713-792-4605 | |
| Principal Investigator: Elizabeth J Shpall, M.D. | |
| Texas Cord Blood Bank | Recruiting |
| San Antonio, Texas, United States, 78201 | |
| Contact: Mary Beth Fisk, AMT,CTBS,CQA 800-292-5534 ext 1865 | |
| Principal Investigator: Rachel-Louise Beddard, M.D. | |
| United States, Washington | |
| Puget Sound Blood Center | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Jess Oh, M.S. 206-292-1896 | |
| Principal Investigator: Thomas H Price, M.D. | |
| Principal Investigator: | John P Miller, M.D., Ph.D. | National Marrow Donor Program |
More Information
| Responsible Party: | John P. Miller, M.D., Ph.D., Vice President & Sr. Medical Director Donor Medical Services, National Marrow Donor Program Center for Cord Blood |
| ClinicalTrials.gov Identifier: | NCT00737516 History of Changes |
| Other Study ID Numbers: | T00004 |
| Study First Received: | August 15, 2008 |
| Last Updated: | July 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Registry Unrelated Umbilical Cord Blood donor Hematopoietic Reconstitution Center for Cord Blood Bone Marrow Transplantation |
|
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 |