| CTRI Number |
CTRI/2021/07/035034 [Registered on: 22/07/2021] 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
|
Alginate encapsulated Stem Cell Transplantation study for Corneal diseases. |
|
Scientific Title of Study
|
A proof of concept study to evaluate the clinical study safety and efficacy of Ex-vivo Cultivated Allogeneic Limbal Stromal Stem Cell Transplantation for Treatment of Superficial Corneal Pathologies after Alginate Encapsulation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HERF-SSC-SCP-02, Version 1.0, Dated 25th June 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 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 |
|
| 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, 2nd Floor GPR Building, HERF LV Prasad Eye Institute Kallam 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 |
|
|
Source of Monetary or Material Support
|
| Hyderabad Eye Research Foundation,Kallam Anji Reddy Campus,LV Prasad Eye Institute, LV Prasad Marg Road No.2 Banjara Hills Hyderabad |
|
|
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= 2 |
| Name of Committee |
Approval Status |
| L V Prasad Eye Institute Ethics Comittee |
Approved |
| LV Prasad ICSCR Committee |
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 encapsulated in Alginate |
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 |
| To evaluate the safety of ex-vivo cultivated allogeneic limbal stromal stem cells for the treatment of visually significant superficial corneal stromal scarring and other pathologies including any ocular or systemic adverse effects at the various post-operative time points. |
Day 1, Day 7, Day 30, Day 90, Day 180 and Day 360 and 720 |
|
|
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 |
|
|
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)
|
16/08/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study proposes to investigate the transplantation of ex-vivo cultivated
allogenic limbal stromal stem cells for the treatment of the corneal
pathologies after alginate encapsulation. 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 stromal stem cells to regenerate
healthy, transparent tissue. |