A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant

Inclusion Criteria:

• Allo-HCT recipients

• Age ≥ 4 years-old

• Oral cGvHD with NIH-modified OMRS score ≥ 3 who have failed ≥ 1 line of therapy,including topical corticosteroids..

• No change in systemic immunosuppressive therapy (type or intensity level) within 2weeks prior to enrollment.

• If a patient is currently using another oral topical treatment for mouthlesions/symptoms, patient must be stable on this treatment for ≥2 weeks prior tostudy enrollment. Patient may continue same topical dose/frequency during the studyperiod.

Exclusion Criteria:

• Presence of an active uncontrolled infection. Subjects with a controlled infectionreceiving definitive therapy for 48 hours prior to enrollment are eligible.

• Personal history of mucosal head and neck cancer in the past 5 years.

• Pregnant or breastfeeding.

• The subject or guardian is unable to give informed consent or unable to comply withthe treatment protocol including appropriate supportive care, follow-up, andresearch tests.

• Any serious medical or psychiatric illness that could, in the Investigator'sopinion, potentially interfere with the completion of treatment according to thisprotocol.