The goals of this core are to provide all projects and the other cores with centralized leadership, administrative. Cord Blood Bank and clinical research support. The Administrative component will be responsible for integrating all components of the program project grant (PO1) and overseeing progress, so that the research objectives are being met. It will provide assistance to each project and core leader with budgetary issues and will oversee the overall fiscal and budgetary management of the program. This Core will also coordinate oversight of the PO1 by convening meetings of the Internal and External Advisory Boards and implementing their recommendations. The goals of the clinical research component of this core are to provide all projects with clinical trial support in collaboration with Core B and provide an infrastructure of personnel and services that will adequately support such research. Core services will be provided in regulatory affairs, study coordination, quality assurance and control and data safety monitoring. The Regulatory Affairs component collaborates with investigators to develop and submit all required regulatory documents, including submissions to the IRB, IBC, FDA, and NIH/OBA and annual reports. This core has extensive experience with IND submission and currently supports over 45 IND studies. The Quality Control program will ensure that standard operating procedures for protocol development, conduct of clinical trials, data collection and management of clinical trials are accurately defined and being followed. The Quality Assurance program will undertake audits after the first patient is enrolled on a study and then randomly to ensure that the studies are being conducted according to Good Clinical Practices. The MD Anderson Cord Blood Bank is committed to providing cord blood units for pre-clinical peer-reviewed research to advance the field of cord blood transplantation, and will provide all the cord blood units needed to execute the studies proposed in the projects. In this PO1 we have developed strategic approaches to overcome the limitations of cord blood transplantation and will rely on testing potential solutions in carefully designed preclinical models and then translating the results to the clinic.

Public Health Relevance

Cord Blood has emerged as an important source of stem cells for patients lacking HLA-matched donors. However, the major disadvantage of cord blood is the low stem and progenitor cell dose resulting in delayed engraftment and immune reconstitution. In this P01 we have developed strategic approaches to overcome the limitations of cord blood transplantation. This Core will provide cord blood units, administrative and clinical research support to achieve the goals of this PO1.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Program Projects (P01)
Project #
4P01CA148600-06
Application #
9340312
Study Section
Special Emphasis Panel (ZCA1)
Program Officer
Merritt, William D
Project Start
2011-09-22
Project End
2017-08-31
Budget Start
2016-09-01
Budget End
2017-08-31
Support Year
6
Fiscal Year
2016
Total Cost
Indirect Cost
Name
University of Texas MD Anderson Cancer Center
Department
Type
DUNS #
800772139
City
Houston
State
TX
Country
United States
Zip Code
77030
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