Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease

Chronic Graft-versus-host Disease Clinical Trial

Official title:

Analysis of Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02611180
• Other study ID #: 201405065
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Graft-versus-host Disease
• Acute GVHD
• Bronchiolitis Obliterans Syndrome
• Chronic Graft-versus-host Disease
• Chronic GVHD
• Graft vs Host Disease

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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine