Clinical trial NCT02649621: The Improvement of Limbal Stem Cell Deficiency (LSCD) in Unilateral Stem Cell Damage by Amniotic Membrane Extract Eye Drop (AMEED)
Official title: The Effect of in Vivo Cultured Limbal Stem Cells in the Treatment of Unilateral Corneal Stem Cell Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Limbal Stem Cell Deficiency (LSCD)
Keywords: Limbal Stem Cell Deficiency Amniotic Membrane Extract Eye Drop in vivo cultivation
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2016-01-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Limbal defect size
timeFrame: 12 months
measure: Corneal epithelial integrity
timeFrame: 12 months
measure: Corneal epithelial stability
timeFrame: 12 months
Secondary outcomes:
measure: Vascularization
timeFrame: 12 months
measure: Transparency
timeFrame: 12 months
measure: Best spectacle corrected visual activity
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Department of Regenerative Biomedicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
name: Marzieh Ebrahimi, PhD
role: STUDY_DIRECTOR
affiliation: Labafi Nejad Eye Research Center, Tehran, Iran
name: Alireza Baradaran, MD
role: STUDY_DIRECTOR
affiliation: Labafi Nejad Eye Research Center, Tehran, Iran
name: Mitra Akbari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Stem Cells and Developmental Biology at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
name: Niloufar Shayan, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Stem Cells and Developmental Biology at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
name: Maryam Momeni, MSc
role: PRINCIPAL_INVESTIGATOR
References: