Transdermal Patch to Monitor Inflammatory Biomarkers of GVHD

Acute skin graft versus host disease is a significant complication following allogeneic stem
cell transplant. To date, there are no specific dermal biomarkers that predict or define the
onset of acute skin graft versus host disease. The primary objective of this study is to
observe the changes in the inflammatory environment of the skin during the process of acute
and chronic skin graft versus host disease. This will be accomplished by using a
non-invasive transdermal patch called D-Squame to analyze inflammatory cytokines and key
epidermal proteins. Patients will be enrolled prior to receiving a stem cell transplant and
followed weekly after stem cell infusion until day 99. If acute skin graft versus host
disease develops, they will be followed weekly until resolution of acute graft versus host
disease or development of chronic graft versus host disease, whichever occurs first.
Patients with a diagnosis of chronic skin graft versus host disease will be enrolled and
followed weekly until 4 weeks, irrespective of clinical course. In addition, healthy
controls will be enrolled and used as comparators. The relevance of this study is to provide
a better understanding of the local inflammatory environment induced by acute or chronic
skin graft versus host disease. This is likely to enable the investigators to define a
biomarker panel that predicts the onset of acute graft versus host disease rapidly and
non-invasively.

Inclusion criteria for patients who may develop acute graft versus host disease:

- All patients undergoing an allogeneic hematopoietic stem cell transplant at CCHMC.

- All conditioning regimens are eligible.

Exclusion criteria for patients who may develop acute graft versus host disease:

• Pre-existing skin conditions like, but not limited to epidermolysis bullosa, psoriasis,
acne, or cellulitis.

Inclusion criteria for patients who have chronic graft versus host disease:

- Bone marrow transplant performed at CCHMC or an outside institution.

- Diagnosis of chronic skin graft versus host disease.

Exclusion criteria for patients who have chronic graft versus host disease:

• Bone marrow transplant performed for epidermolysis bullosa.

Inclusion criteria for controls:

- Healthy volunteers.

- Age matched to the patients with existing acute skin graft versus host disease.

Exclusion criteria for controls:

• Pre-existing dermatologic conditions. (E.g. eczema, psoriasis, acne etc.)