The Application of Cultured Cornea Stem Cells in Patients... | NCT01377311

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

NCT01377311

Sponsor

National Taiwan University Hospital

Status

Terminated

Last Update Posted

Jun 21, 2011Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Unilateral Limbal Stem Cell Insufficiency

Interventions

Transplant of cultured limbal stem cells on cornea

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We didn't use this tech in patient.

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Apr 21, 2011

First Submission Date that Met QC Criteria

Jun 20, 2011

First Posted Date

Jun 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2011

Last Update Posted Date

Jun 21, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Materials and Methods:

Patients suffering from unilateral limbal stem cell insufficiency will be chosen. Make sure those volunteers understand the benefits and risk factors of the operation.
Prepare human amniotic membrane, and culture the membrane at37°C，5% CO2，95% room air.
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)
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
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.
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.
Pictures 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 20 patients from 1 July,2007 to 30, June, 2010

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transplant of cultured limbal stem cells on cornea	Procedure	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei-Li Chen, MD, PhD	National Taiwan University Hospital, department of Ophthalmology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital, department of Ophthalmology		Taipei		10047	Taiwan