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

May 1, 2023 updated by: Center for International Blood and Marrow Transplant Research

The primary purpose of the Research Sample Repository is to make blood samples available for research studies related to histocompatibility and hematopoietic cell transplantation (HCT) or other cellular therapy.

Representatives of participating centers and investigators or research groups may request access to research samples contained in the Research Sample Repository for the purpose of conducting research including:

  • investigating molecular explanations for histocompatibility or clinical outcomes through analysis of genomic, epigenetic, or other biomolecular data
  • evaluating the factors that affect transplant or cellular therapy outcome
  • studying the distribution of HLA tissue types in different populations
  • studying the success of transplantation, cellular therapies or supportive care in the management of marrow toxic injuries
  • performing de-linked (anonymous) research

Study Overview

Status

Recruiting

Conditions

Detailed Description

Research samples will be accepted from the following four categories:

  • Hematopoietic Cell or other Cellular Therapy Donors
  • Cord Blood Units
  • Hematopoietic Cell Transplantation or other Cellular Therapy Recipients
  • Patients with Marrow Toxic Injury

Study Type

Observational

Enrollment (Anticipated)

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
      • New Brighton, Minnesota, United States, 55112
        • Recruiting
        • NMDP Biorepository
        • Contact:

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 a stem cell transplantation process

Description

Eligibility to participate in the Research Sample Repository Protocol:

Hematopoietic Cell (HC) or Other Cellular Therapy Donors

  • Donors are eligible to participate in the Research Sample Repository if they have donated or are scheduled to donate HCs or cellular therapy products to an allogeneic recipient either by a marrow harvest or by apheresis. This includes adults with and without decision making capacity and children.
  • All donors registered on the National Marrow Donor Program (NMDP) Registry, regardless of whether they have been requested to donate a product for a patient, are eligible to participate in the Research Sample Repository.

Cord Blood Units (CBUs)

  • Testable material from CBUs (Specimens) infused at treatment centers covered under the C. W. Bill Young Transplantation Program are eligible for inclusion in the Research Sample Repository. Material may be submitted by participating treatment centers, centralized laboratories and Cord Blood Banks.

Hematopoietic Cell Transplantation or Other Cellular Therapy Recipients

  • All U.S. recipients of allogeneic or autologous HC transplants or cellular therapies are eligible to participate in the Research Sample Repository. This includes adults with and without decision making capacity and children.

Patients with Marrow Toxic Injury

  • 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 Sample Repository. This includes adults with and without decision-making capacity and children.
  • Eligible patients may have received support care only, growth factor support, hematopoietic stem cell transplant or other appropriate medical treatment for marrow toxic injury

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To make blood samples available for research studies related to histocompatibility and HCT or other cellular therapy
Time Frame: pre-HCT (recipient) or pre-donation (donor)
pre-HCT (recipient) or pre-donation (donor)

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: Stephen Spellman, NMDP Be The Match/CIBMTR

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.

Helpful Links

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 (Actual)

July 1, 1991

Primary Completion (Anticipated)

July 1, 2030

Study Completion (Anticipated)

July 1, 2030

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMDP IRB-1991-0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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