About this trial
The purpose of this study is to find out whether photobiomodulation/PBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral Graft-Versus-Host Disease/GVHD.
Eligibility criteria
Qualifiers
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 2 weeks prior to enrollment.
Disqualifiers
Presence of an active uncontrolled infection. Subjects with a controlled infection receiving 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 with the treatment protocol including appropriate supportive care, follow-up, and research tests.
Trial design
Treatments tested in this trial
- Photobiomodulation Therapy
- Placebo sham device