CIBMTR Research Database

August 7, 2025 updated by: Center for International Blood and Marrow Transplant Research

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

99999999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55413
        • Recruiting
        • Center for International Blood and Marrow Transplant Research
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Recipients and Donors that are involved with stem cell transplantation, other cellular therapies, and gene therapies.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Comprehensive Source of Observational Data to assess Stem Cell Transplant
Time Frame: Anually - on average

A primary outcome is to have a comprehensive source of stem cell transplant data that can be used to assess topics such as:

  • Recipient Recover time
  • How recovery after transplant and other cellular therapies can be improved
  • Long term outcomes after transplantation and other cellular therapies
  • How well donors recover from collection procedure
Anually - on average

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Comprehensive Source of Data for Marrow Toxic Injuries
Time Frame: anually- on average
In the event of a radiation exposure accident, the NMDP has a radiation injury treatment network, whose purpose is to collect data to understand the outcomes of patients treated under these circumstances. Any patient who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Treatment Network (RITN) is eligible to participate in the Research Database.
anually- on average
Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (17-CMS-SCD)
Time Frame: annually - on average

This protocol supports data collection for a sub study titled 17-CMS-SCD, an observational study to compare survival of patients 15 to 50 years of age with sickle cell disease who receive allogeneic transplantation compared to those receiving standard of care treatments.

  • To provide a mechanism to Medicare Beneficiaries with sickle cell disease for claims coverage for allogenic hematopoietic cell transplant.
  • To provide data requested by Medicare under its coverage with evidence development (CED) process to make payment on claims for HCT using the existing research observational database for the CIBMTR
annually - on average
Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage (10CMSMDS-1)
Time Frame: annually - on average

This protocol supports data collection for a sub-study titled 10-CMSMDS-1 with objective to prospectively examine outcomes of allogenic hematopoietic cell transplant in adults >= 65 years of age with myelodysplastic syndrome to determine whether their outcomes are similar to those in younger patients.

  • To provide a mechanism for Medicare Beneficiaries with myelodysplastic syndrome for claims coverage for allogenic hematopoietic cell transplant
  • To provide data requested by Medicare under its CED to make payment on claims for HCT using the existing research observational database of the CIBMTR"
annually - on average

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients with Medicare Coverage
Time Frame: annually - on average

This study is the main protocol for the following two sub studies. Details for these sub-studies are found under separate NCT numbers.

  • Multiple Myeloma Medicare Study (NCT03127761): 17-CMS-MM
  • Myelofibrosis Medicare Study (NCT02934477): 16-CMS-MF
annually - on average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for International Blood and Marrow Transplant Research

Investigators

  • Principal Investigator: Patricia Steinert, PhD, MBA, Center for International Blood and Marrow Transplant Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Estimated)

July 1, 2050

Study Completion (Estimated)

July 1, 2050

Study Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

July 19, 2010

First Posted (Estimated)

July 20, 2010

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMDP IRB-2002-0063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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