| CTRI Number |
CTRI/2020/07/026891 [Registered on: 29/07/2020] Trial Registered Prospectively |
| Last Modified On: |
25/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Stem Cell Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of Limbal Stromal Stem Cell for its safety and efficacy for treatment of corneal injuries |
|
Scientific Title of Study
|
A proof of concept study to evaluate the clinical safety and efficacy of Ex-vivo Cultivated Allogeneic Limbal Stem Cell Transplantation for Treatment of Superficial Corneal Pathologies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HERF-SSC-SCP-01, Version 2.0 , Dated 23rd April 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayan Basu |
| Designation |
Director |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Centre of Ocular Regeneration COREHyderabad Eye Research FoundationLV Prasad Eye InstituteKallam Anji Reddy Campus,LV Prasad Eye Institute, LV Prasad Marg Road No.2 Banjara Hills Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
sayanbasu@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVivek Singh |
| Designation |
Scientist |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Centre of Ocular Regeneration, Hyderabad Eye Research FoundationLV Prasad Eye InstituteKallam Anji Reddy Campus,LV Prasad Eye Institute, LV Prasad Marg Road No.2 Banjara Hills Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102286 |
| Fax |
|
| Email |
viveksingh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayan Basu |
| Designation |
Director |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Centre of Ocular Regeneration COREHyderabad Eye Research FoundationLV Prasad Eye InstituteKallam Anji Reddy Campus,LV Prasad Eye Institute, LV Prasad Marg Road No.2 Banjara Hills Hyderabad
Centre of Ocular Regeneration COREHyderabad Eye Research FoundationLV Prasad Eye InstituteKallam Anji Reddy Campus,LV Prasad Eye Institute, LV Prasad Marg Road No.2 Banjara Hills Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
sayanbasu@lvpei.org |
|
|
Source of Monetary or Material Support
|
| Hyderabad Research Foundation |
|
|
Primary Sponsor
|
| Name |
Hyderabad Eye Research Foundation |
| Address |
Hyderabad Eye Research Foundation L V Prasad Eye Institute, Kallam Anji Reddy Campus Road No. 2, L V Prasad Marg, Banjara Hills, Hyderabad 500034 Telangana State, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sayan Basu |
LV Prasad Eye Institute |
Centre of Ocular Regeneration COREHyderabad Eye Research FoundationLV Prasad Eye InstituteKallam Anji Reddy Campus,LV Prasad Eye Institute, LV Prasad Marg Road No.2 Banjara Hills Hyderabad
Hyderabad
TELANGANA |
9989479969
sayanbasu@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, L. V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H178||Other corneal scars and opacities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ex-vivo cultivated limbal stromal stem cells |
0.5 million stromal stem cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female participants who are ≥18 and ≤ 60 years of age.
2. Patients having unilateral superficial corneal pathologies (defined as involving the anterior 200µM of the corneal stroma on ASOCT imaging)
3. Corneal burns, ulcers and scars
4. No prior history of corneal transplantation
5. No ongoing and other active ocular pathology
6. Candidate for stem cell transplant
7. No severe pathological and psychological conditions that might interfere with the patient’s participation in the study
8. Able to provide written and audio-visual informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice |
|
| ExclusionCriteria |
| Details |
1. Bilateral corneal disease,
2. Corneal scars with limbal dysfunction (clinically defined as absent limbal palisades or conjunctivalization of the cornea)
3. Ocular surface disease including dry eye disease (defined as a Schirmer’s test of less than 10mm at 5 minutes),
4. Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation,
5. Children (<18 years of age),
6. Less than 3 months after documented clinical resolution of acute disease
7. Inability/refusal to give written informed consent
8. Undergo any of the anterior segment imaging tests.
9. Patient should have not participated in another clinical study within 30 days of their enrolment on this study.
10. History or evidence of cardiac disease: congestive heart failure; New York Heart Association (NYHA) class 2 or greater (see Appendix 6); 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.
11. Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential
12. Reproductive age patients not practicing effective and adequate birth control measures
13. Previous participation in this study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary outcome measure of this study is to note any ocular or systemic adverse effects of this intervention at the various post-operative time points |
Day 1, Day 7, Day 30, Day 90, Day 180 and Day 360 and 720 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome measures are visual improvement and change in the density and appearance of the corneal scarring and other pathologies after treatment |
Day 1, Day 7, Day 30, Day 90, Day 180 and Day 360 and 720 Days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 1 |
|
Date of First Enrollment (India)
|
05/10/2020 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
SayanBasu, Andrew J. Hertsenberg, Martha L. Funderburgh, Michael K. Burrow, Mary M. Mann, Yiqin Du, Kira L. Lathrop, Fatima N. Syed-Picard, Sheila M. Adams, David E. Birk, James L. Funderburgh., Human limbal biopsy–derived stromal stem cells prevent corneal scarring., Science Translational Medicine 10 December 2014 Vol 6 Issue 266 266ra172 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study proposes to investigate the transplantation of ex-vivo cultivated allogenic limbal stromal cells for the treatment of the corneal pathologies. The limbus is an ideal source as the stem cells are numerous and located very superficially in the tissue (17). Pre-clinical work suggests human corneal stromal stem cells can be isolated from the cadaveric tissues, cultivated in conditions suitable for cell based therapy and used to prevent fibrosis in a murine model of corneal stromal scarring. Further, these cells are able to successfully engraft, differentiate, and mediate wound healing in the corneal stroma such that the tissue remains healthy, free of fibrotic tissue, and optically transparent. The clinical implications of these findings are substantial in that it represents the potential to lessen the burden on donor tissue necessary for corneal allografts by using cultured cells to regenerate tissue. We foresee the ability of a clinician to and grow and expand the cells in number and after surgically removing the scar tissue from the wounded eye, apply the cultured limbal stem cells to regenerate healthy, transparent tissue. |