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Completed

NCT Number: NCT02649621

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

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).

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amniotic Membrane Extract Eye Drop (AMEED)

Biological

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.

Primary outcomes

  1. Limbal defect size

    Time frame: 12 months

    The measurement of limbal defect size by microscope 12 months after corneal surgery

  2. Corneal epithelial integrity

    Time frame: 12 months

    The measurement of Corneal epithelial integrity by microscope 12 months after corneal surgery

  3. Corneal epithelial stability

    Time frame: 12 months

    The measurement of Corneal epithelial stability by microscope 12 months after corneal surgery

Secondary outcomes

  1. Vascularization

    Time frame: 12 months

    Evaluation the rate of corneal vascularization with microscope 12 months after surgery.

  2. Transparency

    Time frame: 12 months

    Evaluation the transparency with visual tests 12 months after surgery.

  3. Best spectacle corrected visual activity

    Time frame: 12 months

    Evaluation the best spectacle corrected visual activity with visual tests.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 7, 2016
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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