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-UMIN000005400

Enrollment

Registered

2011-04-08

Start date

2011-05-01

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

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 of the out patient unit of department of ophthalmology or medical center for translational research in Osaka University Hospital.

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 At least one eye have to fully meet the criteria

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 impossibile to obtain the oral mucosal tissue. 5) Subjects whose performance status is scored over 3 points. 6) Subjects who are not unsuitable for this project by some complications (judged by the docter 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 ContactTakeshi Soma

Osaka University Graduate School of Medicine Department of Ophthalmology

soma@ophthal.med.osaka-u.ac.jp+81-6-6879-3456

Outcome results

None listed

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