Stem Cell Therapeutics Outcomes Database (SCTOD)

• Stem Cell Therapeutic Outcomes Database: What Does It All Mean? (PDF)
• Frequently Asked Questions (FAQs) - coming soon.

What is meant by the Program?

In December 2005, President Bush signed legislation that authorized the C. W. Bill Young Cell Transplantation Program (the Program) as a new structure to support unrelated donor transplantation in the U.S. The Program continues the adult unrelated donor registry, but places a new focus on umbilical cord blood cells (CBU) for use in transplantation and cellular therapy. The five key components of the Program are:

• National Cord Blood Inventory (NCBI) to collect high quality CBU
• Bone Marrow Coordinating Center (BMCC) to manage the adult unrelated donor registry
• Cord Blood Coordinating Center (CBCC) to manage the NCBI search and distribution of CBU
• Office of Patient Advocacy/Single Point of Access for health care professionals and patients
• Stem Cell Therapeutic Outcomes Database (SCTOD) to collect outcomes data

Who is involved?

All Contracts are awarded and overseen by the Health Services and Resources Administration (HRSA).

• Initial contracts for the NCBI were awarded to six US Cord Blood Banks.
• The Coordinating Center and Single Point of Access contracts were awarded to the National Marrow Donor Program.
• The SCTOD Contract was awarded to the Center for International Blood and Marrow Transplant Research (CIBMTR).

Can you explain the SCTOD?

Congress has legislated that outcomes data must be collected on all patients "who have been recipients of a stem cell therapeutics product (including bone marrow, cord blood, or other such product) from a donor." This includes all allogeneic transplants, both related and unrelated, where either the donor or the recipient resides in the U.S. The CIBMTR, as recipient of the SCTOD Contract, is responsible for the administration of this activity and the collection and analysis of the data.

What are the new challenges for the CIBMTR?

Important aspects of the Program requiring changes in practice and procedure are:

• Development of new systems to collect data electronically;
• Enhanced efforts to develop a standard dataset of clinical hematopoietic stem cell transplant data;
• New requirements for U.S. centers to report outcomes data for all allogeneic transplantations;
• Development of a related donor recipient research sample repository;
• Systems to make more data publicly available;
• Broadened reporting of U.S. transplant center-specific survival rates to include outcome of related donor transplants;
• Data collection on uses of hematopoietic stem cells for new therapeutic applications (e.g., regenerative medicine).

How does this affect the CIBMTR and the NMDP?

Collaborative efforts will allow CIBMTR and NMDP to meet the new challenges and requirements dictated by the Program. The two campuses are strategically adjusting internal procedures to implement the new contracts, including collecting data on a harmonized paper form and electronic data collection system. Once developed, the new Program will offer new research opportunities to the transplant community and streamline data collection. A combined continuous process improvement (CPI) and audit program is also in development.

When does this become effective?

The law was passed on December 19, 2005. The SCTOD Contract was activated on September 27, 2006. CIBMTR is undertaking an educational initiative starting with the 2007 BMT Tandem Meeting and continuing over a long "ramp-up" period of time. CIBMTR expects to launch the harmonized form and the new electronic data collection system simultaneously in July 2007.

Where can I learn more information about the Stem Cell Therapeutic Outcomes Database?

Articles about the SCTOD and the C. W. Bill Young Program can be found in the December 2006 CIBMTR Newsletter and the November 1, 2006 ASBMT eNews. 2007 BMT Tandem Meeting SCTOD Web Presentations may be viewed online at http://www.asbmt.org/News/Outcomes.

MORE INFORMATION TO FOLLOW