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Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency

Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency - Cultivated oral mucosal epithelial cell sheet transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012260
Enrollment
10
Registered
2013-11-11
Start date
2012-12-01
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

Corneal epithelial stem cell deficiency: Patients who have dysfunction of the entire limbus with almost replaced by conjunctival epithelium, neovascularization and corneal scarring tissue.

Interventions

Harvest of the oral mucosal tissue is conducted at the University of Tokyo Hospital. The tissue is transferred to Osaka University Hospital, and oral mucosal cell sheets are produced. The produced s

Sponsors

Department of Ophthalmology, Graduate School of Medicine, The University of Tokyo
Lead Sponsor
Department of Ophthalmology, Osaka University Graduate School of Medicine
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Total limbal stem cell deficiency 2) Entire corneal surface is covered by conjunctival tissue 3) Regardless of gender, and must be over 20 years old when the subjects agree with this project 4) The signed consent is required

Exclusion criteria

Exclusion criteria: 1) Subjects who are pregnant, plan to become pregnant, or are breast-feeding. 2) Subjects who have systemic infections (HBV, HCV, HIV, HTLV-1) 3) Subjects who have extremely severe dry eye 4) Subjects who have extensive oral mucosal scarring and impossible to obtain the oral mucosal tissue. 5) Subjects who are not unsuitable for this project by some complications (judged by the doctor in charge).

Design outcomes

Primary

MeasureTime frame
To evaluate a size of epithelial defect and conjunctivalized corneal surface area in first postoperative year.

Secondary

MeasureTime frame
1. Improved visual acuity 2. Improved corneal opacity 3. Improved corneal neovascularization 4. Expected eye complications 5. All adverse events

Countries

Japan

Contacts

Public ContactTomohiko Usui

Graduate School of Medicine, The University of Tokyo Department of Ophthalmology

tomohiko-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

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