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System development of cultivated oral mucosal epithelial transplantation for limbal stem cell deficiency in Thailand

System development of cultivated oral mucosal epithelial transplantation for limbal stem cell deficiency in Thailand

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190927004
Enrollment
10
Registered
2019-09-27
Start date
2019-09-26
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

cultivated oral mucosal epithelial transplantation for limbal stem cell deficiency
Experimental Procedure/Surgery
cultivated oral mucosal epithelial transplantation

Sponsors

National Science and Technology Development Agency
Lead Sponsor

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

MeasureTime 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

Secondary

MeasureTime frame
N/A N/A N/A

Contacts

Public ContactPinnita Prabhasawat

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

pinnita.pra@mahidol.ed+6624198037

Outcome results

None listed

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