The Improvement of Limbal Epithelial Culture Technique by Using Collagenase to Isolate Limbal Stem Cells

July 24, 2014 updated by: National Taiwan University Hospital

The Improvement of Limbal Epithelial Culture Technique for the Treatment of Unilateral Limbal Insufficiency by Using Collagenase to Isolate Limbal Stem Cells

Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment of patients suffering from unilateral limbal stem cell insufficiency based on the concept of "limbal stem cells need special cell-cell contact and cell-extracellular matrix interaction to support their survival".

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients suffering from unilateral limbal stem cell insufficiency and understand the benefits and risk factors of the operation will be enrolled in this clinical trial. Two weeks before transplantation, the investigators first take 1-2 mm2 of limbal tissues from the healthy eye, digest the tissue with collagenase, and get an epithelial cell cluster. The cell cluster will be cultured on amniotic membrane with SHEM medium which contains Dulbecco's modified Eagle's medium/F12 (1:1), 5% dimethyl sulfoxide, 10 ng/ml human epidermal growth factor, 5μg/ml insulin, 0.5 μg/ml hydrocortisone, 1 nM cholera toxin, 50μg/ml gentamicin, 1.25μg/ml amphotericin B. Seven to ten days later after successful culture, transplantation will be performed after the cells reaches 1.5-2 cm2 compact confluent epithelial sheets without evidence of contamination. During the operation, lamellar keratectomy will be performed to remove the abnormal corneal neovascularization and scar tissue. The cultivated epithelial sheets will be transplanted to denuded corneal surface with fibrin glue and suture technique. The patients are planed to be admitted for 2 weeks. After discharge, follow up of the patients will be performed on one week, two week, one month, two months, three months, six months and one year later. Pictures of external eyes will be taken and the extent of corneal epithelium regeneration, visual acuity, and complications will be recorded during follow-up visits. The investigators plan to collect 10 patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • Wei-Li Chen

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: between 18-70 years old.
  2. Lesion eye should have limbal insufficiency more than 180 degrees.
  3. Lesion eye should have recurrent corneal erosions, corneal neovascularisation and poor vision caused by limbal insufficiency.
  4. The symptoms should be more than 1/2 year, and have no possibility of improvement by medical treatment.
  5. The patients will to received the operation and the long term post- operative follow-up.
  6. The patients are not infected by AIDS, hepatitis B/C , and willing to received the associated examinations.
  7. The patients does not plan to be pregnant from the day of cell culture and transplantation for 1 year. They also agree to receive the pregnant test.
  8. The condition of cell culture from the 1st to the clinical trial is successful.

Exclusion Criteria:

  1. Bilateral limbal insufficiency.
  2. No recurrent corneal erosion, corneal neovascularisation or poor vision was found due to limbal insufficiency. If corneal neovascularisation was found deeper than the anterior 1/2 of corneal stroma, or corneal thickness was less than 200 um evaluated by anterior segment OCT and ultrasound pachymetry, the patients should be excluded from the operation criteria. If corneal thickness becomes thicker, the patients can be enrolled for operation.
  3. About corneal sedation, if the value checked by Cocet-Bonnet esthesiometer is less than 5 mm, the patients should be excluded from operation.
  4. The condition can be improved by medication, or resolve spontaneously.
  5. Post-operative follow up is less than 1/2 year
  6. The patient can't receive long term postoperative follow up
  7. No light perception, or can be expected to have very poor prognosis
  8. If the intraocular pressure was more than 21 mmHg under necessary glaucoma surgery and anti-glaucoma medication, or optic disc cupping was more than 90%, or visual field was found to have severe defects, the patients were excluded from the clinical trial.
  9. Severe lagophthalmos or trichiasis, and does not received blepharoplasty.
  10. Severe dry eye syndrome. Those patients with schirmer's test result less than 1 mm should be excluded.
  11. If the cells in the first part of the clinical trial can't be successfully cultivated, the patients should be excluded. If the patients insisted to received further treatment, they can be enrolled 3 months later.
  12. Pregnancy

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: limbal stem cells
Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment of patients suffering from unilateral limbal stem cell insufficiency based on the concept of "limbal stem cells need special cell-cell contact and cell-extracellular matrix interaction to support their survival"
Procedure: collagenase
Cultured limbal stem cells transplantation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment.
Time Frame: 12 months
Nine to twelve days later after successful culture, transplantation will be performed after the cells diameter reaches 1.5-2.0 cm compact confluent epithelial sheets without evidence of contamination.
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201007032D

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