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-UMIN000012264

Enrollment

Registered

2013-11-11

Start date

2013-03-12

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

Bilateral corneal epithelial stem cell deficiency: Patients with severe intractable ocular surface disease who have dysfunction of the entire limbus with totally replaced by conjunctival epithelium, neovascularization and corneal scarring tissue. (*Corneal epithelial stem cell deficiency: It is possible to make the diagnosis by using slit lamp microscopy showing loss of the palisades of Vogt (POV) and a conjunctivalized corneal surface which also can be seen by characteristic fluorescein stainin

Interventions

Harvest of the oral mucosal tissue is conducted at the operation room in Ehime University Hospital. The tissue is transferred to Osaka University Hospital, and oral mucosal cell sheets are produced. T

then graft survival and stabilization of epithelial cells are attained.

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

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

Secondary

Measure	Time 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 ContactAtsushi Shiraishi

Ehime University Graduate School of Medicine Department of Ophthalmology

shiraia@m.ehime-u.ac.jp+819011730885

Outcome results

None listed

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