The Improvement of Limbal Stem Cell Deficiency (LSCD) in Unilateral Stem Cell Damage by Amniotic Membrane Extract Eye Drop (AMEED)

January 6, 2016 updated by: Royan Institute

The Effect of in Vivo Cultured Limbal Stem Cells in the Treatment of Unilateral Corneal Stem Cell Damage

Corneal epithelial cells and limbal stem cells (LSC) are located in the limbus basal epithelium that are necessary for repair of corneal. About patients with deficient or absence of this area has been proposed various treatments such as limbal stem cell transplantation.

This study is a prospective clinical trial to compare the improvement of limbal stem cell deficiency (LSCD) in vivo by using of Amniotic Membrane Extract Eye Drop (AMEED).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The cornea is the eye anterior portion which its refractive power and transparent is essential for normal vision.

The damaged cornea surface can reduce vision and leads to blindness, ultimately. Corneal epithelial and some times, limbal stem cell (LSC) are involved in corneal injuries. Limbal stem cells (LSC) are necessary for repair and reconstruction of corneal that reduction of these cells occurs by various causes including congenital causes, eye inflammatory diseases and burns. For cornea stem cell damages or limbal stem cell deficiency (LSCD), cornea becomes conjunctivalization. LSCD may involve one eye (unilateral) or two eyes (bilateral).

Due to autologous transplantation problems in patients with unilateral LSCD and recent successes to resolve this problem, it seems that transplantation of cultured corneal stem cells on amniotic membrane is other way in treatment of unilateral LSCD. It is called ex vivo.

Amniotic membrane can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. It is well accepted that amniotic membrane transplantation (AMT) as a temporary patch normally dissolves within 2 weeks. Consequent reapplication of membrane is difficult for the patient. On the other hand, in ex vivo, corneal tissue from healthy eye must be transported to laboratory for cell culture on AM that is required equipment. There is, also, a risk of cell infection and transmission that is very important issue. However, in infected cells, re-biopsy of the healthy eye is required that is uncomfortable and difficult for the patient. Other studies have been reported that amniotic membrane extract (AME) has same characteristics and features.

We previously have reported an effective potential of AMEED in limbal stem cell proliferation in vitro and also rabbit corneal epithelium healing in vivo.

This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) on in vivo cultured limbal stem cells in the treatment of unilateral corneal stem cell damage.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with unilateral chemical burn (grade III to up); estimation of chemical burns amount and classification was according to Dua.
  • Without Age limitation

Exclusion Criteria:

  • Lack of timely referral of patients for examinations
  • Simultaneous use of other drugs that cause impairment of the data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amniotic Membrane Extract Eye Drop recipient
patients with limbal stem cell Deficiency who receive amniotic membrane transplantation and amniotic membrane extract eye drop as eye drop.
Biological: Amniotic Membrane Extract Eye Drop (AMEED)
Use of use Amniotic Membrane Extract Eye Drop (AMEED) on in vivo cultured limbal stem cells in the treatment of unilateral corneal stem cell damage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limbal defect size
Time Frame: 12 months
The measurement of limbal defect size by microscope 12 months after corneal surgery
12 months
Corneal epithelial integrity
Time Frame: 12 months
The measurement of Corneal epithelial integrity by microscope 12 months after corneal surgery
12 months
Corneal epithelial stability
Time Frame: 12 months
The measurement of Corneal epithelial stability by microscope 12 months after corneal surgery
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascularization
Time Frame: 12 months
Evaluation the rate of corneal vascularization with microscope 12 months after surgery.
12 months
Transparency
Time Frame: 12 months
Evaluation the transparency with visual tests 12 months after surgery.
12 months
Best spectacle corrected visual activity
Time Frame: 12 months
Evaluation the best spectacle corrected visual activity with visual tests.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Study Director: Marzieh Ebrahimi, PhD, Department of Regenerative Biomedicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
  • Study Director: Alireza Baradaran, MD, Labafi Nejad Eye Research Center, Tehran, Iran
  • Principal Investigator: Mitra Akbari, MD, Labafi Nejad Eye Research Center, Tehran, Iran
  • Principal Investigator: Niloufar Shayan, MSc, Department of Stem Cells and Developmental Biology at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
  • Principal Investigator: Maryam Momeni, MSc, Department of Stem Cells and Developmental Biology at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Estimate)

January 7, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Eye-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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