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

Phase 1

Completed

• Conditions: Limbal Stem Cell Deficiency (LSCD)

• Registration Number: NCT02649621
• Lead Sponsor: Royan Institute

Brief Summary

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).

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 Timeline

• Study Start: 2011-08
• Primary Completion: 2012-03
• Study Completion: 2012-08
• Status Verified: 2016-01
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-06
• Last Update Submitted: 2016-01-06
• Study First Posted: 2016-01-07
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Limbal defect size	12 months	The measurement of limbal defect size by microscope 12 months after corneal surgery
Corneal epithelial integrity	12 months	The measurement of Corneal epithelial integrity by microscope 12 months after corneal surgery
Corneal epithelial stability	12 months	The measurement of Corneal epithelial stability by microscope 12 months after corneal surgery

Secondary Outcome Measures

Name	Time	Method
Best spectacle corrected visual activity	12 months	Evaluation the best spectacle corrected visual activity with visual tests.
Transparency	12 months	Evaluation the transparency with visual tests 12 months after surgery.
Vascularization	12 months	Evaluation the rate of corneal vascularization with microscope 12 months after surgery.