CTRI/2020/07/026891
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: H178- Other corneal scars and opacities
- Sponsor
- Hyderabad Eye Research Foundation
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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