Ocular Surface Reconstruction With Cultivated Autologus M... | NCT01942421

Studies
Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation

NCT01942421

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Sep 16, 2013Estimated

Enrollment

20Estimated

Phase

Phase 2Phase 3

Conditions

Ocular Surface Disease

Interventions

Cultivated mucosal epithelial transplantation

Countries

Thailand

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

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jun 2013Actual

Completion Date

Dec 2013Estimated

First Submitted Date

Dec 6, 2011

First Submission Date that Met QC Criteria

Sep 10, 2013

First Posted Date

Sep 16, 2013Estimated

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

Sep 10, 2013

Last Update Posted Date

Sep 16, 2013Estimated

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

The purpose of this study is to elucidate the appropriate condition of developing cultivated autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients.

Detailed Description

Ocular surface damage caused by severe ocular surface diseases. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications. Ocular surface reconstruction with cultivated autologous mucosal epithelial transplantation is served to improve the surgical results of ocular surface reconstruction and decrease the use of immunosuppressive medications

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cultivated mucosal epithelial transplant	Experimental	Cultivated mucosal epithelial transplantaion to limbal deficiency patients	Procedure: Cultivated mucosal epithelial transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cultivated mucosal epithelial transplantation	Procedure	cultivated autologous mucosal epithelium, then transplant to limbal stem cell deficiency patients.	Cultivated mucosal epithelial transplant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery		Three years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology

Exclusion Criteria:

Age under 18
Active ocular infection, Severe dry eye, Uncontrolled glaucoma
Immunocompromised host
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pinnita Prabhasawat, MD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pinnita Prabhasawat, MD		Bangkok	Thailand	10300	Thailand