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

Overseen By Caroline Bumb

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Hepatitis B, Hepatitis C, HTLV, HIV, pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eynav Klechevsky, Ph.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo skin biopsies and peripheral blood collection for research purposes, with optional additional biopsies on day 5-7 and day 28

4 weeks

Multiple visits for biopsies and blood collection

Follow-up

Participants are monitored for dendritic cell and lymphocyte characteristics in skin and blood samples

Up to 2 years

Treatment Details

Interventions

• Dendritic Cells

Participant Groups

Group I: Arm 2: Chronic skin GVHD Experimental Treatment 2 Interventions

* 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.

Group II: Arm 1: Acute skin GVHD Experimental Treatment 2 Interventions

* 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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+