Graft-versus-host Disease Associated Myelosuppression

July 7, 2016 updated by: Technische Universität Dresden

Functional Profiling of the Hematopoietic Stem Cell Niche in Graft Versus Host Disease Mediated Bone Marrow Insufficiency

The objective is to measure the frequency, functionality and phenotype of bone marrow-derived mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be monitored at the same time. These results will be correlated with the extent of cytopenia and clinical graft-versus-host disease grading.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

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

  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden
        • Contact:
          • Malte von Bonin, MD

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with AML/MDS receiving an allogeneic hematopoietic stem cell transplantation

Description

Inclusion Criteria:

  • age >18
  • acute myeloid leukemia
  • myelodysplastic syndrome
  • hematopoietic stem cell transplantation

Exclusion Criteria:

  • not willing to take part

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
Changes in the amount of mesenchymal stromal cells after allogeneic hematopoietic stem cell transplantation
Time Frame: up to 1 year after allogeneic hematopoietic stem cell transplantation
up to 1 year after allogeneic hematopoietic stem cell transplantation

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Malte von Bonin, MD, Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden

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

April 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bone marrow GvHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Graft vs Host Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe