| CTRI Number |
CTRI/2025/02/081002 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Stem Cell Therapy
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Examining the efficacy of limbal stem cells grown on amniotic membrane as a treatment for limbal stem cell deficiency mediated blindness |
|
Scientific Title of Study
|
Autologous Cultivated Limbal Stem Cell Transplantation on Amniotic Membrane Scaffold to Achieve Corneal Surface Repair and Visual Rehabilitation. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishakha S Shetty |
| Designation |
Senior Resident |
| Affiliation |
K.S Hegde Medical Academy |
| Address |
Dr. Vaishakha S. Shetty,
Senior Resident,
Department of Ophthalmology,
KS Hegde Charitable Hospital,
Deralakatte, Mangaluru, Karnataka-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8971924271 |
| Fax |
|
| Email |
vaishakha.shetty@nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveenkumar Shetty |
| Designation |
Professor, Director (R&D) |
| Affiliation |
K.S.Hegde Medical Academy |
| Address |
Dr. Praveenkumar Shetty, Professor, Director (R&D).
6th floor, University Enclave, Medical Science Complexes, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8971465632 |
| Fax |
|
| Email |
praveenkumarshetty@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishakha S Shetty |
| Designation |
Senior Resident |
| Affiliation |
K.S.Hegde Medical Academy |
| Address |
Dr. Vaishakha S. Shetty,
Senior Resident,
Department of Ophthalmology,
KS Hegde Charitable Hospital,
Deralakatte, Mangaluru, Karnataka-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8971924271 |
| Fax |
|
| Email |
vaishakha.shetty@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| KS Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka-575018 |
|
|
Primary Sponsor
|
| Name |
DrVaishakhaSShetty |
| Address |
Dr. Vaishakha S. Shetty,
Senior Resident,
Department of Ophthalmology,
KS Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka-575018
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Praveenkumar Shetty |
Dr Praveenkumar Shetty Professor Director (R&D)
6th floor University Enclave
Medical Science Complexes
Nitte Deemed to be University
Deralakatte Mangaluru
Karnataka 575018
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaishakha S Shetty |
KS Hegde Charitable Hospital, Deralakatte |
Department of Ophthalmology,
KS Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka-575018.
Dakshina Kannada
KARNATAKA |
8971924271
vaishakha.shetty@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee of Nitte Deemed to be University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H188||Other specified disorders of cornea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 stem cells of limbus in in vitro conditions. Next, the in vitro grown epithelial stem cells of limbus will be trypsinized and re-seeded on denuded human amniotic membrane to obtain a confluent monolayer of limbal stem cells on amniotic membrane. The resulting amniotic membrane will be transplanted on the cornea of patients suffering from unilateral limbal stem cell deficiency. This is intended to be one time intervention which should provide better visual acuity due to corneal re-epithelization. So the duration of intervention which is by suturing the amniotic membrane on damaged eye it could be 60 min of procedure. |
| Comparator Agent |
na |
na |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Possible corneal re-epithelialization in the patients suffering from Limbal stem cell deficiency
|
Day1
Day7
Day15
Day 30
Day 60
Day 90
Day 180
Day 360 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
Day 15
Day30
Day60
Day 90
Day180
Day360 |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [praveenkumarshetty@nitte.edu.in].
- For how long will this data be available start date provided 01-12-2026 and end date provided 27-11-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The clinical trial is a non-randomized non-blinded, single centre interventional study to assess the efficacy of autologous limbal stem cells (LSC) expanded on decellularized human amniotic membrane (HAM) as a dual transplant to cure unilateral limbal stem cell deficiency (LSCD). LSCD is an extremely debilitating eye disorder which is painful and cause blinding. In the proposed clinical trial, decellularized human amniotic membrane (HAM) will be used as surrogate niche for ex-vivo expansion of LSC and the same will be transplanted on LSCD patients. We expect that treated patients will show corneal re-epithelialization, the primary outcome of our clinical trial. As a secondary outcome, there will be improved visual acuity and improved quality of life of in LSCD patients. Additionally, 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. |