The Application of Cultured Cornea Stem Cells in Patients Suffering From Corneal Stem Cell Insufficiency

June 20, 2011 updated by: National Taiwan University Hospital

Phase 1 Study of Cornea Stem Cells Cultured on Amniotic Membrane Transplanted on Patients Suffering From Corneal Stem Cell Insufficiency

Name of the project：The application of cornea stem cells cultured on amniotic membrane in patients suffering from corneal stem cell insufficiency

Purpose: To develop the technique of using ex vivo expansion of autologous limbal stem cell cultured on amniotic membrane for treatment of patients suffering from limbal stem cell insufficiency

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Materials and Methods:

  1. Patients suffering from unilateral limbal stem cell insufficiency will be chosen. Make sure those volunteers understand the benefits and risk factors of the operation.
  2. Prepare human amniotic membrane, and culture the membrane at37°C，5% CO2，95% room air.
  3. One month before transplantation, take 1-2mm2 of limbal tissues from the healthy eye, and culture the limbal tissue on amniotic membrane with 1.5 ml supplemental hormonal epithelial medium (in 5%的 fetal calf serum)
  4. Keep culturing the cells in Dulbecco's modified Eagle's medium/Ham's F12 (1:1 ratio), added with 5 % dimethyl sulfoxide, 2 mg/ml human epidermal growth factor ,5 ug/ml insulin, 0.5 ug/ml hydrocortisone, 50 ug/ml gentamicin, 1.25 ug/ml amphotericin B, 5% autoserum。Two to three weeks later, transplantation will be performed after the cells reaches 2-3 cm2
  5. Remove the abnormal surface tissue on the lesion cornea, transplant the amniotic membrane with cultured limbal stem cells on the denuded cornea. Cover with contact lens after operation, and apply topical antibiotics and steroids.
  6. Postoperatively, observe the patients for one week. After discharge, follow up the patients one week, two week, one month, two months, three months, six months and one year later.
  7. Pictures will be taken and the extent of corneal epithelium regeneration, visual acuity, and complications will be recorded during follow-up visits.
  8. The investigators plan to collect 20 patients from 1 July,2007 to 30, June, 2010

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10047
        • National Taiwan University Hospital, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unilateral limbus defect larger than 180 degrees
  • repeated corneal epithelial ulcer, loss of visual acuity or neovascularization due to limbal stem cell insufficiency
  • no improvement after medical intervention for more than 6 months
  • the patient is willing to receive surgery and postoperative follow up

Exclusion Criteria:

  • bilateral limbus defect
  • limbal stem cell insufficiency does not induce repeated corneal epithelial ulcer, loss of visual acuity or neovascularization
  • corneal neovascularization deeper than 1/2 depth of surface matrix
  • peripheral surface matrix is less than 200um thick
  • no corneal reflex was induced by fiber less than 5mm length measured by Cocet-Bonnet esthesiometer
  • improvement under medication
  • perisurgical follow up less than 6 months
  • unable to be long term followed up postoperatively
  • glaucoma patients underwent glaucoma surgery, under medication, IOP > 21mmHg
  • glaucoma patients underwent glaucoma surgery, under medication, IOP < 21mmHg, optic disc depression > 90%
  • severe incomplete eyelid closure
  • severe dye eye syndrome, Schirmer test 5 min < 3 mm
  • contralateral eye limbus tissue cannot be obtained, or unable to be cultured
  • pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients suffering from unilateral limbal stem cell insufficiency. Remove the abnormal surface tissue on the lesion cornea, transplant the amniotic membrane with cultured limbal stem cells on the denuded cornea. Cover with contact lens after operation, and apply topical antibiotics and steroids.
Procedure: Transplant of cultured limbal stem cells on cornea
Remove the abnormal surface tissue on the lesion cornea, transplant the amniotic membrane with cultured limbal stem cells on the denuded cornea. Cover with contact lens after operation, and apply topical antibiotics and steroids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The extent of corneal epithelium regeneration
Time Frame: one week, two week, one month, two months, three months, six months and one year later
one week, two week, one month, two months, three months, six months and one year later

Secondary Outcome Measures

Outcome Measure
Time Frame
visual acuity
Time Frame: one week, two week, one month, two months, three months, six months and one year later
one week, two week, one month, two months, three months, six months and one year later
complications
Time Frame: one week, two week, one month, two months, three months, six months and one year later
one week, two week, one month, two months, three months, six months and one year later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (Estimate)

June 21, 2011

Study Record Updates

Last Update Posted (Estimate)

June 21, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 32MD02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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