Protocol for A Research Sample Repository for Allogeneic Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

Clinical Trial Details

The purpose of storing a blood sample from donors and their recipients in the NMDP/CIBMTR Research Sample Repository is to provide cells and plasma (the liquid portion of blood) for the NMDP/CIBMTR Research Sample Repository. By studying the cells and plasma of donors and recipients, researchers may learn more about improving the tissue matching between unrelated donors and their recipients. Increasing knowledge about tissue matching could result in the improved long-term survival of bone marrow and stem cell transplant recipients. Although the exact study for which your sample may be used is not known at this time, the following are types of studies in which your sample may be included. Studies to:

Improve the understanding of tissue matching for unrelated donors and recipients;
Determine and evaluate the factors that affect transplant outcome and cellular therapy outcome;
Study the distribution of HLA tissue types in different populations; e.g., to study tissue typing differences between different racial ethnic populations to help develop methods to improve tissue matching between donors and recipients.

In addition, investigators may conduct research studies with stored blood samples that have had all identifiers removed. In these studies, there will be no way for the sample to be linked to you. CIBMTR may allow investigators to use these anonymous samples for many other kinds of studies. Any research project may be proposed for anonymous research; such as studies that look for the presence of traits linked to other diseases, like diabetes.

All research studies using these blood samples must first be approved by a group of scientists within the CIBMTR as well as the Repository Oversight Committee. The proposed study will also be reviewed to make sure the research is consistent with the types of studies described above.

Key Eligibility:

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.

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.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Ashlee N. Torres, RN
(212) 746-7117
ant9105@med.cornell.edu

Primary Investigator(s)

Tsiporah B Shore, MD (UES)

Protocol ID(s)

Weill Cornell Medicine IRB #:

0211005881

ClinicalTrials.gov:

NCT01166009

Status

Open to Enrollment

Age Group

Adult

Disease

Cancer

Bone Marrow Transplant

Hematologic Malignancies

Solid Tumors