CIBMTR Research Database

Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies.

A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries.

Objectives:

To learn more about what makes stem cell transplants and cellular therapies work well such as:

• Determine how well recipients recover from their transplants or cellular therapy;
• Determine how recovery after a transplant or cellular therapy can be improved;
• Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy;
• Determine how access to transplant or cellular therapy for different groups of patients can be improved;
• Determine how well donors recover from the collection procedures.

Eligibility to Participate in the Research Database

Recipient Eligibility Criteria:

• Any recipient of an unrelated or related donor or autologous HSC transplant in a CIBMTR center is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children.

Individual with Marrow Toxic Injury Eligibility Criteria:

• Any individual who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Transplant Network (RITN) is eligible to participate in the Research Database. This includes adults with and without decision making capacity, and children. Eligible individuals may have received supportive care only, growth factor support, HSC transplant or other appropriate medical treatment for marrow toxic injury. Treatments applied are at the discretion of the care facility, and are not determined by the NMDP or CIBMTR.

Unrelated Donor Eligibility Criteria:

• All donors registered on the NMDP Registry who have been requested to donate a product for a recipient are eligible to participate in the Research Database.
• All maternal cord blood donors are enrolled in the NMDP Cord Blood Bank Investigational New Drug (IND) protocol, and sign an informed consent document specific to that protocol. Data collected as part of the Cord Blood Bank protocol are included in the Research Database.