Development of Corneal-Endothelial Regenerative Medicine Involving Cultivated Human Corneal Endothelial Cell Injectio

Phase 2

Recruiting

• Conditions: Bullous Keratopathy; Cornea Endothelial dysfunction

• Registration Number: JPRN-jRCTa050190118
• Lead Sponsor: Shigeru Kinoshita

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

BSCVA under 0.5
corneal endothelial cell density unmesurable or under 500cells per mm2
Corneal thickness over 630 micro meter with corneal epithelial edema

Exclusion Criteria

corneal infection
pregnant
bleeding tendency
mental disability
uncontrolable glaucoma
uncontrolable diabetes
autoimmune disease
cancer patient
heart disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corneal Endothelial Cell Density > 500 cells/mm^2 (24W)

Secondary Outcome Measures

Name	Time	Method
Corneal Endothelial Cell Density > 500 cells/mm^2 (52W, 104W)<br>Corneal Thickness < 630 micro meter and no corneal epithelial edema (24W, 52W, 104W)<br>Improvement of visual acuity (24W, 52W, 104W)<br>Improvement of VFQ-25 (24W)