Examining the efficacy of limbal stem cells grown on amniotic membrane as a treatment for limbal stem cell deficiency mediated blindness

Autologous Cultivated Limbal Stem Cell Transplantation on Amniotic Membrane Scaffold to Achieve Corneal Surface Repair and Visual Rehabilitation. - nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/081002

Enrollment

Registered

2025-02-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: H188- Other specified disorders of cornea

Interventions

Intervention1: Autologous epithelial stem cells of limbus cultivated on human amniotic membrane.: Fragments of autologous limbus biopsies(~1mm) will be used to produce confluent layer of epithelial st

Eligibility

Inclusion criteria

Inclusion criteria: Unilateral limbal stem cell deficiency caused due to 1. ocular burns, 2. chemical injury, 3. injury due to UV radiation, 4. Ocular surface squamous neoplasia, 5. recurrent pterygium, 6. mild cases of Stevens-Johnson syndrome 7. Mucous membrane pemphigoid

Exclusion criteria

Exclusion criteria: 1. patients with bilateral corneal disease, 2. Ocular surface disease including dry eye disease, defined as a Schirmer s test of less than 10mm at 5 minutes, 3. h/o prior history of corneal transplantation 4. h/o ongoing and other active ocular pathology 5. h/o severe pathological and psychological conditions that might interfere with the patient s participation in the clinical trial 6. Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation, 7. Inability/refusal to give written informed consent 8. History or evidence of cardiac disease: congestive heart failure, active coronary artery disease, unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization. 9. Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential

Design outcomes

Primary

Measure	Time frame
Possible corneal re-epithelialization in the patients suffering from Limbal stem cell deficiency Timepoint: Day1 Day7 Day15 Day 30 Day 60 Day 90 Day 180 Day 360	—

Secondary

Measure	Time frame
Improvements in the visual acuity due to possible corneal re-epithelialization. After successful completion of proposed clinical trial, a centre for limbal stem cell transplantation at KS Hegde Charitable Hospital, NITTE (DU) can be established to treat LSCD patients of Karnataka and neighbouring districts of Kerala Timepoint: Day 15 Day30 Day60 Day 90 Day180 Day360	—

Countries

India

Contacts

Public ContactDr Vaishakha S Shetty

K.S.Hegde Medical Academy

praveenkumarshetty@nitte.edu.in8971465632

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026