Utilization of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Healing

NCT ID: NCT02746848

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-11-30

Brief Summary

For severe ocular surface diseases, such as chemical and thermal injuries, Stevens-Johnson syndrome (SJS), Band Keratopathy, Corneal Dystrophies, Refractive (PRK-LASEK), corneal surgery and others, it is important that short time treatment with minimal side effect should be considered. This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing

Detailed Description

The cornea is the specific anterior part of eye that is essential for normal vision. The corneal surface is comprised of a unique type of non-keratinized epithelial cell. Corneal epithelium contains transient amplifying cells and post mitotic cells. The limbal stem cells (LSC) are located between limbal cornea and conjunctiva which are main source of corneal epithelium healing in eye injuries. For some corneal disease such as chemical and thermal injuries, Corneal Dystrophies and corneal surgery, treatment in short time is important.

AM can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. This biological substrate maintain epithelial progenitor cells within the limbal stem cell niche and facilitate ocular surface epithelial renewal. 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.

Other studies have been reported that processed AM as a liquid has comparable effect to AMT in treatment of corneal epithelial healing.

This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing.

Conditions

Cornea Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with cornea injury

Patients with cornea injury who received healing Amniotic Membrane Extract Eye Drop.

Group Type: EXPERIMENTAL

Amniotic Membrane Extract Eye Drop

Intervention Type: BIOLOGICAL

Amniotic Membrane Extract use as eye drop for patients with corneal injury.

Interventions

Amniotic Membrane Extract Eye Drop

Amniotic Membrane Extract use as eye drop for patients with corneal injury.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patient with corneal epithelium injury

2. Without keratoconus

3. Without cornea scar

4. Without any other lesion of cornea

Exclusion Criteria

1. Lack of timely referral of patients for examinations

2. Simultaneous use of other drugs that cause impairment of the data

3. Previous cornea surgery

4. Dry eye

5. Glaucoma

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Royan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Marzieh Ebrahimi, PhD

Role: STUDY_DIRECTOR

Department of Regenerative Biomedicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.

Khosro Jadidi, MD

Role: STUDY_DIRECTOR

Bina Hospital, Research & Education Center, Tehran, Iran

Fatemeh Doostmohammadi, MD

Role: PRINCIPAL_INVESTIGATOR

Bina Hospital, Research & Education Center, Tehran, Iran

Related Links

http://royaninstitute.org

Related Info

Other Identifiers

Royan-Eye-003

Identifier Type: -

Identifier Source: org_study_id