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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02568527
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : August 9, 2018
Wellcome Trust
University of Sheffield
Information provided by (Responsible Party):
Virender S Sangwan, MBBS, MS, L.V. Prasad Eye Institute

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Limbal Stem Cell Deficiency Device: PLGA scaffold Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : July 2018

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 Name: Purasorb PDLG 5004

Primary Outcome Measures :
  1. Corneal Edema using Pachymetry [ Time Frame: 12 months ]
    At Baseline and at Month 12

  2. Intraocular Pressure by Standard Applanation Tonometry [ Time Frame: 12 months ]
    At Baseline and at Month 12

  3. Ocular Pain [ Time Frame: 12 months ]
    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)

  4. Schirmer's test (5 minute) without anesthesia [ Time Frame: 12 months ]
  5. Clinical Laboratory Adverse Events [ Time Frame: 12 months ]
  6. Vital Signs [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Regeneration of Stable Ocular Surface measured by Slit lamp Biomicroscopy Examination and Slit Lamp Photography [ Time Frame: 12 months ]
  2. Best Corrected Visual Acuity by Snellen Chart [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02568527

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LV Prasad Eye Institute
Hyderabad, Andhra Pradesh, India, 500034
Sponsors and Collaborators
Virender S Sangwan, MBBS, MS
Wellcome Trust
University of Sheffield
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Principal Investigator: Virender S Sangwan, MBBS MS LV Prasad Eye Institute
Study Director: Sayan Basu, MBBS MS LV Prasad Eye Institute
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Responsible Party: Virender S Sangwan, MBBS, MS, Director, Center for Ocular Regeneration (CORE), L.V. Prasad Eye Institute Identifier: NCT02568527    
Other Study ID Numbers: LVPEI-2012-11
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Virender S Sangwan, MBBS, MS, L.V. Prasad Eye Institute:
Donor Human Amniotic Membrane (hAM)