Submission of Stem Cell Transplant Data to CIBMTR and NMDP

Background:

- In 2005, the United States Congress legislated that outcome data would 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. The Health Services and
Resources Administration (HRSA) awarded the contract for this Stem Cell Therapeutic
Outcomes Database (SCTOD) to the Center for International Blood and Marrow
Transplantation (CIBMTR). The CIBMTR is thus responsible for the administration of this
activity and collection and analysis of the data. The CIBMTR was established in 2004 as
an affiliation between the National Marrow Donor Program (NMDP) and the Medical College
of Wisconsin.

- NCI - ETIB and POB, in order to comply with the SCTOD requirements, will participate in
the CIBMTR Outcomes Data Reporting process for all autologous and related allogeneic
hematopoietic cell therapy recipients and donors. Patients receiving unrelated donor
cell therapies will participate in a separate data collection protocol designed to
satisfy the requirements for participation as an NMDP transplant center as well as the
SCTOD reporting.

Objectives:

- To meet the reporting requirements of the Stem Cell Therapeutic Outcomes Database.

Eligibility:

- All patients receiving autologous or related allogeneic hematopoietic stem cell
transplants will be eligible regardless of age, diagnosis, or disease status.

Design and Modifications from CIBMTR protocol:

- Patients will be consented prior to the start of their pre-transplant conditioning
regimen.

- Related donors will be consented prior to the start of their mobilization or, if no
mobilization, prior to the date of cell collection.

- Patients and donors who do not wish to participate will still have a minimum set of
data submitted, as required by law. However, this data will not be used in research.

- For privacy concerns, the following data will not be collected or reported: Social
Security Number (SSN), Mother's Maiden Name, Country of birth, Median household income,
Education and Occupation. This data may be omitted without affecting compliance with
the SCTOD. All other demographic data collected at NIH will be stored separate from the
research records in a locked cabinet accessible only to those with roles directly
related to reporting the data.

- 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.