Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in LSCD Patients

Study to Evaluate Safety & Efficacy of PLGA Scaffold to Regenerate Limbal Epithelial Cells Using Autologous Limbal Grafts by SLET (Simple Limbal Epithelial Transplant) Procedure in Patients Having Total Unilateral LSCD

The purpose of this clinical study is to undertake a pilot safety and efficacy study of a synthetic biodegradable membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure

Study Overview

• Status: Completed
• Conditions: Limbal Stem Cell Deficiency
• Intervention / Treatment: Device: PLGA scaffold

Detailed Description

This study will involve the used of a synthetic biodegradable Poly Lactide-co-Glycolic Acid (PLGA) biodegradable, synthetic carrier membrane (PLGA) membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure.

This has the potential to simplify the current procedure and make it safer and accessible to more surgeons and eventually benefit more patients. The use of PLGA membrane, in place of hAM for limbal transplants, is a novel technique and has a lot of promise and potential, which will potentially benefit patients at large and significantly bring down costs for the limbal transplants while reducing the disease transmission risks of using human donor tissue.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500034
      • LV Prasad Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female participants who are ≥18 years of age.

2. Patients having a confirmed diagnosis of total LSCD as confirmed by any one or all of the following:

   • In-growth of conjunctival epithelium over the cornea (conjunctivalization),
   • 360o absence of limbal Palisades of Vogt,
   • A fine stippled appearance on fluorescein staining,
   • Persistent or recurrent corneal epithelial defects
   • Superficial vascularization,
   • Dull and irregular corneal epithelium.
3. Participants having unilateral limbal stem cell deficiency due to chemical injury
4. No prior history of limbal transplantation
5. No ongoing and other active ocular pathology
6. No severe pathological and psychological conditions that might interfere with the patients participation in the study
7. Able to provide written 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 LSCD
2. LSCD due to autoimmune disorders and partial LSCD
3. Having other ongoing ocular pathologies and acute ocular inflammation
4. Previous neoplastic/cancer disease
5. Severe dry eyes confirmed by Schirmer's test
6. Acute systemic infections
7. Prior history of limbal transplantation surgery or multiple surgeries in the limbal region
8. Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study results.
9. Any uncontrolled, inter-current illness that in the opinion of the Investigator may interfere with study evaluation.
10. Participants with uncontrolled diabetes will be excluded from the study
11. 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.
12. Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential
13. Reproductive age patients not practicing effective and adequate birth control measures
14. Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study.

15. Previous participation in this study

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLGA Scaffold; Poly Lactide-co-Glycolic Acid (PLGA) 50:50	Device: PLGA scaffold; Poly-Lactic-co-Glycolic Acid (50:50) biodegradable, synthetic scaffold; Other Names: Purasorb PDLG 5004

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Edema using Pachymetry	At Baseline and at Month 12	12 months
Intraocular Pressure by Standard Applanation Tonometry	At Baseline and at Month 12	12 months
Ocular Pain	Magnitude of pain will assessed as patient reported outcome using Visual Analogue Scale (VAS) in a scale of 1 to 10 (Wong-Baker Faces Pain Rating Scale)	12 months
Schirmer's test (5 minute) without anesthesia		12 months
Clinical Laboratory Adverse Events		12 months
Vital Signs		12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Regeneration of Stable Ocular Surface measured by Slit lamp Biomicroscopy Examination and Slit Lamp Photography	12 months
Best Corrected Visual Acuity by Snellen Chart	12 months

Collaborators and Investigators

• Sponsor: Virender S Sangwan, MBBS, MS
• Collaborators: University of Sheffield; Wellcome Trust
• Investigators: Principal Investigator: Virender S Sangwan, MBBS MS, LV Prasad Eye Institute; Study Director: Sayan Basu, MBBS MS, LV Prasad Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: October 3, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: LSCD; SLET; Donor Human Amniotic Membrane (hAM); PLGA
• Other Study ID Numbers: LVPEI-2012-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No