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

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The Washington University

Status

Enrolling

Conditions

Chronic GVHD
Acute GVHD
Chronic Graft-versus-host Disease
Acute Graft-versus-host Disease

Treatments

Procedure: Skin punch biopsy
Procedure: Peripheral blood draw

Study type

Observational

Funder types

Other

Identifiers

NCT02611180
201405065

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Arm 1: Acute skin GVHD
Description:
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.
Treatment:
Procedure: Peripheral blood draw
Procedure: Skin punch biopsy
Arm 2: Chronic skin GVHD
Description:
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.
Treatment:
Procedure: Peripheral blood draw
Procedure: Skin punch biopsy

Trial contacts and locations

1

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Central trial contact

Caroline Bumb; Eynav Klechevsky, Ph.D.

Data sourced from clinicaltrials.gov

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