Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myelodysplastic Syndromes, Leukemia, Lymphoma

Intervention / Treatment
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* Biological: HPC, Cord Blood


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnancy Exclusion Criteria: -
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>HPC, Cord Blood | Biological: HPC, Cord Blood<br>* Search for HLA compatible cord blood units using the NMDP registry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study safety and efficacy for treatment for malignant and non-malignant disorders |  | annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study relationship between HLA disparity and survival |  | annually | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry, Unrelated Umbilical Cord Blood donor, Hematopoietic Reconstitution, Center for Cord Blood, Bone Marrow Transplantation