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

This study has been terminated.
(We didn't use this tech in patient.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01377311
First Posted: June 21, 2011
Last Update Posted: June 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose

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


Condition Intervention Phase
Unilateral Limbal Stem Cell Insufficiency Procedure: Transplant of cultured limbal stem cells on cornea Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Cornea Stem Cells Cultured on Amniotic Membrane Transplanted on Patients Suffering From Corneal Stem Cell Insufficiency

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The extent of corneal epithelium regeneration [ Time Frame: one week, two week, one month, two months, three months, six months and one year later ]

Secondary Outcome Measures:
  • visual acuity [ Time Frame: 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 ]

Enrollment: 0
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377311


Locations
Taiwan
National Taiwan University Hospital, department of Ophthalmology
Taipei, Taiwan, 10047
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wei-Li Chen, MD, PhD National Taiwan University Hospital, department of Ophthalmology
  More Information

Responsible Party: Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01377311     History of Changes
Other Study ID Numbers: 32MD02
First Submitted: April 21, 2011
First Posted: June 21, 2011
Last Update Posted: June 21, 2011
Last Verified: June 2011

Keywords provided by National Taiwan University Hospital:
limbal stem cell
amniotic membrane
ex vivo expansion of autologous limbal stem cell
unilateral limbal stem cell insufficiency