NCT06952114

A Study of Stem Cells Lenses in the coGVHD Subjects

A Single Dose Phase I Study to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Stem Cells Lenses in the Chronic Ocular Graft-versus-Host Disease Subjects

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Guangdong ProCapZoom Biosciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Ocular Graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	Stem Cells Lenses	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.

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-12-30
• Completion: 2026-02-28
• First posted: 2025-04-30
• Last updated: 2025-05-08