Acute Graft-versus-host DiseaseNCT02611180
Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease
An observational study of Acute Graft-versus-host Disease and Acute GVHD, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft-versus-host Disease, Acute GVHD, Chronic Graft-versus-host Disease
- What is being tested?
- Skin punch biopsy and Peripheral blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2015to 30 Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with current or suspected acute or chronic GVHD of the skin
Who may be able to join
- 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
Who cannot join
- Known infection with Hepatitis B or C, HTLV, or HIV
- Pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Analysis of Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease
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.
- Conditions
- Acute Graft-versus-host Disease, Acute GVHD, Chronic Graft-versus-host Disease, Chronic GVHD
- Being tested
- Skin punch biopsy, Peripheral blood draw
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin punch biopsyProcedure or surgery
Peripheral blood drawProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Acute skin GVHD | * When clinically indicated, patients will undergo a skin biopsy to confirm a suspected diagnosis of acute or chronic GVHD, or to assess the status of their previously diagnosed acute or chronic GVHD. After the necessary samples are obtained for optimal medical care of the patient, two 6 mm punch biopsies (or four 4 mm punch biopsies) will be performed for research purposes, one (or two) of the affected area and one (or two) of a non-affected area (normal skin).
* Patients who have clinical resolution of their acute or chronic GVHD will undergo one additional 6 mm punch biopsy (or two additional 4 mm punch biopsies) of the previously affected area. This additional biopsy should occur within 10 cm of the previous affected area sample.
* With each skin biopsy, peripheral blood will be obtained by venipuncture or cannulation of an indwelling venous access device.
* Two optional skin biopsies. One on day 5-7 of treatment and one on day 28 from the start of treatment. Receives: Procedure: Skin punch biopsy; Procedure: Peripheral blood draw | |
| Arm 2: Chronic skin GVHD | * When clinically indicated, patients will undergo a skin biopsy to confirm a suspected diagnosis of acute or chronic GVHD, or to assess the status of their previously diagnosed acute or chronic GVHD. After the necessary samples are obtained for optimal medical care of the patient, two 6 mm punch biopsies (or four 4 mm punch biopsies) will be performed for research purposes, one (or two) of the affected area and one (or two) of a non-affected area (normal skin).
* Patients who have clinical resolution of their acute or chronic GVHD will undergo one additional 6 mm punch biopsy (or two additional 4 mm punch biopsies) of the previously affected area. This additional biopsy should occur within 10 cm of the previous affected area sample.
* With each skin biopsy, peripheral blood will be obtained by venipuncture or cannulation of an indwelling venous access device.
* Two optional skin biopsies. One on day 5-7 of treatment and one on day 28 from the start of treatment. Receives: Procedure: Skin punch biopsy; Procedure: Peripheral blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
Genes and skin microbiota that correlate with dendritic cell function
Measured: Up to 2 years
Potential treatment targets as measured by deep sequencing or microarray analysis
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start30 Apr 2015
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft-versus-host DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eynav Klechevsky, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611180
- Sponsor's protocol ID
- 201405065
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2015
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No