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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-UMIN000006745
Enrollment
10
Registered
2011-11-28
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

Interventions

Harvest of the oral mucosal tissue is conducted at the central operation room or the operation room of the outpatient unit of department of ophthalmology in Tohoku University Hospital. The safety of h

Sponsors

Department of Ophthalmology, Tohoku University Graduate School of Medicine
Lead Sponsor

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

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 ContactShunji Yokokura

Tohoku University Graduate School of Medicine Department of Ophthalmology

yokokura@oph.med.tohoku.ac.jp+81-22-717-7294

Outcome results

None listed

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