The Improvement of Limbal Stem Cell Deficiency (LSCD) in Unilateral Stem Cell Damage by Amniotic Membrane Extract Eye Drop (AMEED)
Condition: Limbal Stem Cell Deficiency (LSCD)
MeSH terms: Limbal Stem Cell Deficiency
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Amniotic Membrane Extract Eye Drop (AMEED)
Intervention type(s): Biological
Intervention description(s): 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.
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Limbal Stem Cell Deficiency Amniotic Membrane Extract Eye Drop in vivo cultivation