Limbal stem cell deficiency (LSCD) is a condition characterized by the loss or dysfunction of limbal stem cells, leading to chronic corneal epithelial defects, inflammation, and corneal opacity. The use of mesenchymal stem cells (MSCs) has emerged as a potential therapeutic option for managing LSCD. MSC therapy has been shown to reduce inflammation, promote normal angiogenesis on the ocular surface, and stimulate the regeneration of epithelial cells. Additionally, MSCs have been found to increas
Conditions
Interventions
Participants will receive a single subconjunctival injection of mesenchymal stem cells (MSCs) at a volume of 0.5 mL administered at the site of conjunctival fibrosis or adjacent to the corneal lesion
Experimental Drug
Subconjunctival Mesenchymal Stem Cell Injection
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age more than 18 years 2. Patients diagnosed with limbal stem cell deficiency (LSCD) in one or both eyes, caused by various etiologies such as chemical or thermal burns, Stevens-Johnson syndrome (SJS), chronic keratitis, graft-versus-host disease, severe allergic conjunctivitis and keratitis, multiple ocular surgeries, advanced pterygium leading to stem cell loss, or long-term use of topical medications, as well as idiopathic LSCD. The study will be conducted on the eye with more severe disease. 3. Patients presenting with clinical signs of total LSCD (involvement of 180 degrees or more of the corneal circumference), or with corneal neovascularization and conjunctivalization, or with persistent epithelial defects unresponsive to standard medical treatment. 4. Corneal confocal microscopy findings consistent with LSCD, showing conjunctival epithelial ingrowth into the central cornea or absence of normal corneal epithelium. 5. Impression cytology findings consistent with LSCD, confirmed by immunofluorescence assay (IFA) staining, demonstrating conjunctival epithelial cells replacing corneal epithelial cells on the corneal surface, or absence of corneal epithelial characteristics in the central cornea.
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrolled glaucoma despite medical treatment. 2. Patients with acquired immunodeficiency syndrome (AIDS). 3. Patients with hepatitis C virus infection. 4. Patients with active ocular infections. 5. Patients with severe systemic diseases that contraindicate ocular surgery, such as serious cardiac or pulmonary conditions. 6. Pregnant patients. 7. Patients who are unable to attend follow-up visits. 8. Patients unable to cooperate with treatment due to psychological or physical impairment. 9. Patients with allergies to local anesthetics or corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity (VA) Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, Month 12 Best corrected visual acuity measured using a Snellen chart and converted to LogMAR | — |
Secondary
| Measure | Time frame |
|---|---|
| Corneal thickness Baseline, Month 1, Month 3, Month 6, Month 9, Month 12 Corneal thickness measured using anterior segment optical coherence tomography (CASIA),In vivo confocal microscopy Baseline, Month 3, Month 6, Month 9, Month 12 Assessment of corneal cellular morphology and inflammatory cell density using in vivo confocal microscopy,Complete epithelialization Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, Month 12 Measurement of corneal epithelial defect using fluorescein staining assessed with slit lamp examination,Quality of life Baseline, Month 1, Month 12 Quality of life evaluated using the VFQ-25 questionnaire,Intraocular pressure Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, Month 9, Month 12 Intraocular pressure measured using tonometry,Cornea clarity Baseline, Month 1, Month 3, Month 6, Month 9, Month 12 Corneal clarity assessed using Pentacam ,Corneal neovascularization Baseline, Month 1, Month 3, Month 6, Month 9, Month 12 Evaluation of corneal neovascularization using slit lamp photography and anterior segment imaging,Impression cytology with immunofluorescence (ICIF) Baseline, Month 3, Month 6, Month 9, Month 12 Quantification of corneal and conjunctival epithelial cells using impression cytology combined with immunofluorescence assay | — |
Countries
Thailand
Contacts
Public ContactChareenun Chirapapaisan
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed