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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02611180
Other study ID # 201405065
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 30, 2015
Est. completion date April 30, 2025

Study information

Verified date March 2024
Source Washington University School of Medicine
Contact Eynav Klechevsky, Ph.D.
Phone 314-286-0897
Email eklechevsky@wustl.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Dendritic cells (DCs) serve as sentries for the immune system. DCs recognize foreign compounds (antigens) in the body, which they internalize and process. When DCs uptake foreign antigens, they migrate to secondary lymphoid organs, where the processed antigens are presented to T cells. Various DC subsets with unique cell lineages, surface protein markers, and tissue localization determinants have been identified. For example, Langerhans cells (LCs) and interstitial dendritic cells (intDCs) are DCs found in stratified epithelia, such as the skin. Though both are expressed in the skin, they differ with respect to their origin and surface protein content and can activate distinct types of immune responses. They may also have different specificities for the capture of antigens and presentation to circulating T cells. To date, it is unknown what role, if any, the different DC populations that reside or repopulate in the skin play in the development and progression of skin graft-versus-host disease (GVHD) following bone marrow transplant.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 18 years of age at enrollment - Willing and able to sign the informed consent - Current diagnosis/suspected diagnosis of acute skin GVHD OR Current diagnosis/suspected diagnosis of chronic skin GVHD Exclusion Criteria: - Known infection with Hepatitis B or C, HTLV, or HIV - Pregnant females

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Skin punch biopsy

Peripheral blood draw


Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dendritic cell characteristics Both GVHD affected and unaffected skin sections will be analyzed by immunostaining and the types of cells and strains of skin microbiota present will be analyzed
The different isolated DCs will be activated by different stimuli and will be characterized by gene (DNA, RNA sequencing or arrays) and multicolor flow cytometry analysis.
Up to 2 years
Primary Antigen specific lymphocyte subset characteristics Both GVHD affected and unaffected skin sections will be analyzed by immunostaining and the types of cells and strains of skin microbiota present will be analyzed
CD4+ and CD8+ T cells or other lymphocyte populations will be isolated from peripheral blood by fluorescence activated cell sorting. The DC subsets purified from the skin tissue will be used to stimulate these T cell populations. This will be followed by thorough characterization of the charged T cell populations by a variety of methods. These will include assays to measure proliferation, gene array analysis cytokine secretion and other functions of the charged T cells.
Up to 2 years
Primary Genes and skin microbiota that correlate with dendritic cell function Up to 2 years
Primary Potential treatment targets as measured by deep sequencing or microarray analysis Up to 2 years
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