Protocol for a Research Database for HCT, Other Cellular Therapies and Marrow Toxic Injuries

Last updated: N/A
Sponsor: Medical College of Wisconsin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Marrow Transplant

Anemia

Treatment

N/A

Clinical Study ID

NCT02401009
01166009
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary goal of the CIBMTR Research Program is to improve the safety and effectiveness of hematopoietic cell (HC) transplantation for both donors and recipients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any recipient of an unrelated or related donor or autologous HC transplant (includescells collected from peripheral blood, bone marrow or cord blood) or any recipient ofcellular therapy in a CIBMTR center is eligible to participate in the ResearchDatabase. This includes adults with and without decision making capacity, andchildren.

  • Individual with Marrow Toxic Injury Eligibility Criteria

  • In the event of a radiation exposure accident, the National Marrow Donor Program (NMDP) has a radiation injury treatment network, whose purpose is to collect data tounderstand the outcomes of patients treated under these circumstances.

  • Any individual who is treated for a marrow toxic injury at a center participating inthe NMDP's Radiation Injury Treatment Network (RITN) is eligible to participate in theResearch Database.

  • This includes adults with and without decision making capacity, and children.

  • Eligible individuals may have received supportive care only, growth factor support, HCtransplant or other appropriate medical treatment for marrow toxic injury.

  • Treatments applied are at the discretion of the care facility, and are not determinedby the NMDP or CIBMTR.

  • Unrelated Donor Eligibility Criteria

  • All donors registered on the NMDP Registry who have been requested to donate a productfor a recipient are eligible to participate in the Research Database.

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 390000
Study Start date:
January 01, 1972
Estimated Completion Date:
July 31, 2022

Study Description

The Research Database contains demographic and clinical data on allogeneic related and unrelated donor and autologous HC transplants. Data are also collected on unrelated donors and their donation experiences. The data contained in the research databases are observational data. The Center for International Blood and Marrow Transplant Research (CIBMTR) does not determine which therapies are used for patients, but rather collects information regarding therapies as they are applied by transplant centers.

Secondary goals of the CIBMTR Research Program are to understand uses of hematopoietic cells for regenerative medicine or immune-based therapy, including for malignancy or infection, and to improve treatments and outcomes for those individuals who have been exposed to radiation or other chemicals that are toxic to marrow. In these cases, exposure data, organ injury data, treatment data, and outcomes data are collected.

Connect with a study center

  • Center for International Blood and Marrow Transplant Research

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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