Alginate encapsulated Stem Cell Transplantation study for Corneal diseases.

Phase 1

• Conditions: Health Condition 1: H178- Other corneal scars and opacities

• Registration Number: CTRI/2021/07/035034
• Lead Sponsor: Hyderabad Eye Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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 patientâ??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

Exclusion Criteria

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 Schirmerâ??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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.Timepoint: Day 1, Day 7, Day 30, Day 90, Day 180 and Day 360 and 720

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measures are visual improvement and change in the density and appearance of the corneal scarring and other pathologies after treatment.Timepoint: Day 1, Day 7, Day 30, Day 90, Day 180 and Day 360 and 720