Investigator Initiated Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection

Investigator Initiated Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection - Investigator Initiated Confirmatory Trial of Cultivated Human Corneal Endothelial Cell Injection

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034334

Enrollment

Registered

2018-10-01

Start date

2018-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bullous keratopathy

Interventions

fixed volume of cells

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: BSCVA under 0.5 corneal endothelial cell density unmeasurable or under 500cells per mm^2 corneal thickness over 630 micro meter with corneal epithelial edema

Exclusion criteria

Exclusion criteria: corneal infection pregnant uncontrolable glaucoma uncontrolable diabetes drug hypersensitivity autoimmune disease under another trial treated by cultivated human corneal endothelial cell injection to another eye within 52W cancer patient heart disease difficult-to-prone maintain

Design outcomes

Primary

Measure	Time frame
Corneal Endothelial Cell Density > 1000 cells/mm^2 (24W)	—

Secondary

Measure	Time frame
Corneal Thickness < 630 micro meter and no corneal epithelial edema(24W) Improvement of visual acuity (24W)	—

Countries

Japan

Contacts

Public ContactKojiro Imai

Kyoto Prefectural University of Medicine Department for Medical Innovation and Translational Medical Science

chcec@koto.kpu-m.ac.jp075-251-5308

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026