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

Primary Purpose

Alkaline Chemical Burn Of Cornea And Conjunctival Sac, Acid Chemical Burn Of Cornea And Conjunctival Sac, Benign Mucous Membrane Pemphigoid With Ocular Involvement

Status

Unknown status

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

collagenase

About this trial

This is an interventional treatment trial for Alkaline Chemical Burn Of Cornea And Conjunctival Sac

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Bilateral limbal insufficiency.
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.
About corneal sedation, if the value checked by Cocet-Bonnet esthesiometer is less than 5 mm, the patients should be excluded from operation.
The condition can be improved by medication, or resolve spontaneously.
Post-operative follow up is less than 1/2 year
The patient can't receive long term postoperative follow up
No light perception, or can be expected to have very poor prognosis
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.
Severe lagophthalmos or trichiasis, and does not received blepharoplasty.
Severe dry eye syndrome. Those patients with schirmer's test result less than 1 mm should be excluded.
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.
Pregnancy

Sites / Locations

Wei-Li ChenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

limbal stem cells

Arm Description

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"

Outcomes

Primary Outcome Measures

Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02202642

First Posted

April 21, 2011

Last Updated

July 24, 2014

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02202642

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alkaline Chemical Burn Of Cornea And Conjunctival Sac, Acid Chemical Burn Of Cornea And Conjunctival Sac, Benign Mucous Membrane Pemphigoid With Ocular Involvement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

limbal stem cells

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

collagenase

Intervention Description

Cultured limbal stem cells transplantation

Primary Outcome Measure Information:

Title

Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment.

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: between 18-70 years old. Lesion eye should have limbal insufficiency more than 180 degrees. Lesion eye should have recurrent corneal erosions, corneal neovascularisation and poor vision caused by limbal insufficiency. The symptoms should be more than 1/2 year, and have no possibility of improvement by medical treatment. The patients will to received the operation and the long term post- operative follow-up. The patients are not infected by AIDS, hepatitis B/C , and willing to received the associated examinations. 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. The condition of cell culture from the 1st to the clinical trial is successful. Exclusion Criteria: Bilateral limbal insufficiency. 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. About corneal sedation, if the value checked by Cocet-Bonnet esthesiometer is less than 5 mm, the patients should be excluded from operation. The condition can be improved by medication, or resolve spontaneously. Post-operative follow up is less than 1/2 year The patient can't receive long term postoperative follow up No light perception, or can be expected to have very poor prognosis 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. Severe lagophthalmos or trichiasis, and does not received blepharoplasty. Severe dry eye syndrome. Those patients with schirmer's test result less than 1 mm should be excluded. 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. Pregnancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Li Chen, MD, PhD

Phone

886-2-23123456

Ext

5206

chenweili@ntu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Li Chen, MD, PhD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wei-Li Chen

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

12. IPD Sharing Statement

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

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