This study is a single dose, Phase I study to evaluate the safety, tolerability, and preliminary effectiveness of Stem cells Lenses in the coGVHD Subjects. Three subject's enrollments are Expected. Each subject will wear Stem cells Lenses loaded for four consecutive days. After a 4-day treatment period, a 14-day follow-up observation period will be conducted to monitor for potential adverse events. This study aims to treat patients with chronic ocular graft-versus-host-disease. Currently, there are no approved drugs for the treatment of coGVHD. Three conventional treatments currently available-systemic administrations, topical treatments, and surgical therapies-have various limitations. allo-HSCT involves the transplantation of hematopoietic stem cells from a healthy donor to a recipient with malignant blood diseases such as leukemia to regenerate the hematopoietic and immune systems. A logical strategy for treating the condition directly would involve the administration of UCMSCs. Using UCMSCs to locally modulate donor T cells and prevent them from attacking the ocular surface tissues of the recipient would be a viable approach to the etiological treatment of coGVHD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Each subject will wear Stem Cells Lenses for four consecutive days. After a 4-day treatment period, a 14-day follow-up observation period will be conducted to monitor for potential adverse events.
Adverse events
Incidence and severity of AEs from subjects receiving administration to Day 18 post-administration
Time frame: during the treatment period and within 14 days after treament
Corneal fluorescein staining scores
Changes in corneal fluorescein staining scores
Time frame: From baseline to Day 4 and Day 18 post-administration
Ocular surface disease
Changes in ocular surface disease index scores
Time frame: From baseline to Day 4 and Day 18 post-administration
Schirmer's test
Changes in Schirmer's test
Time frame: From baseline to Day 4 and Day 18 post-administration
Tear osmolarity
Changes in tear osmolarity
Time frame: From baseline to Day 4 and Day 18 post-administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.