Corneal Epithelium Repair and Therapy Using Autologous Limbal Stem Cell Transplantation

Summary

Corneal disease is a leading cause of blindness in the world. A shortage of corneal donor tissue has prevented many patients from regaining vision. Additionally, refractive error such as myopia is a major cause of impaired visual function worldwide. Although refractive error is correctable by procedures that modify the refractive power of the cornea, these procedures often weaken corneal integrity and have risk of complications. This study aims to evaluate the safety and efficacy of corneal surface epithelium repair and regeneration in the treatment of corneal surface diseases and refractive error using autologous limbal stem cell transplantation.

Conditions

• Corneal Disease
• Pterygium
• Myopia
• Hyperopia

Interventions

PROCEDURE

LSCs and amniotic membrane (Modified Technique)

Limbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following removal of scar tissue due to chemical injury or pterygium. The contact lens will then be covered with amniotic membrane to secure it in place. The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched.

PROCEDURE

Amniotic membrane only (Traditional Technique)

Amniotic membrane alone will be used to cover the corneal surface, after removal of scar tissue from a chemical injury or pterygium.

PROCEDURE

PRK, LSCs, and amniotic membrane (Modified Technique)

Limbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following photo-refractive keratectomy (PRK). The contact lens will then be covered with amniotic membrane to secure it in place. The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched.

PROCEDURE

PRK only (Traditional Technique)

PRK alone will be performed.

DRUG

Levofloxacin

DRUG

Betamethasone

DRUG

Limbal stem cells (LSCs)

Sponsors & Collaborators

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Yizhi Liu, MD, PhD · Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2014-06-30

Completion

2014-09-30

Countries

• China

Study Locations