Development of simple limbal epithelial transplantation for treatment of limbal stem cell deficiency in Thailand

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20170609001

Enrollment

Registered

2017-06-09

Start date

2017-02-03

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Limbal stem cell deficiency limbal stem cell deficiency (LSCD)

Interventions

A small limbal donor is cut into multiple pieces and placed on the recipient surface prepared with human amniotic membrane to support in vivo expansion of epithelial cells. After transplantation&#44

limbal stem cells are able to survive and regenerate epithelium on an amniotic membrane&#44

restoring the entire corneal surface.

Experimental Procedure/Surgery

Simple limbal epithelial transplantation

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with unilateral or bilateral limbal stem cell deficiency (LSCD) from chemical or thermal burns, chronic keratitis, multiple corneal surgeries, and prolonged use of eye drops 2. Patients with clinical signs of LSCD at least 180 degrees of the corneal circumference 3. Patients diagnosed with LSCD by impression cytology

Exclusion criteria

Exclusion criteria: 1. Patients aged below 18 years 2. Patients with severe dry eye (Schirmer's test = 0 mm) 3. Patients with uncontrollable glaucoma 4. HIV-infected patients 5. Patients with hepatitis C virus infection 6. Patients with ongoing ocular infection 7. Patients with contraindications of ocular surgery or general anesthesia 8. Patients with pregnancy 9. Patients unable to follow-up 10. Patients with non-compliance, physically or mentally Additional exclusion criteria for allo-SLET patients 1. Patients with contraindications of immunosuppressive agents or sterioids e.g. uncontrollable diabetes mellitus, ongoing systemic infection, hepatic failure, renal failure, etc. 2. Patients allergic to immunosuppressive agents or steroids

Design outcomes

Primary

Measure	Time frame
Ocular surface status pre-op, post-op at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 mo signs of limbal deficiency, impression cytology, and in vivo confocal microscopy,Ocular surface status Three years signs of limbal deficiency, impression cytology, and in vivo confocal microscopy	—

Secondary

Measure	Time frame
N/A N/A N/A	—

Contacts

Public ContactPinnita Prabhasawat

Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University

pinnita.pra@mahidol.edu+6624198037

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026