NCT01237600

CompletedPhase 2/3

Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocul...

Mahidol University Source

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Other study identifiers

Sponsor study identifier

447/2550(EC2)

Study Type

interventional

Actual enrollment (reported)

19

Locations

1 country

Sites

1

Timeline

Study Start

January 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2011

Actual (reported)

Study Completion

November 2011

Actual (reported)

Brief Summary

The purpose of this study is to elucidate the appropriate condition of developing cultivated corneal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated corneal epithelial stem cell in the patients.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 19 participants
Study completion date: November 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 8, 2010
Actual (reported)
First Posted
November 9, 2010
Actual (reported)
Primary Completion
April 2011
Actual (reported)
Study Completion
November 2011
Actual (reported)

Last Updated: December 7, 2011
Status Verified: December 2011
Last Update Submitted: December 5, 2011

Conditions

Limbal Deficiency Severe Ocular Surface Damage

Keywords

Ocular surface damageLimbal deficiencyCultivated corneal epithelial stem cell transplantation

Outcome Measures

Primary Outcomes (1)

Ocular surface status (signs of limbal deficiency and immunopathological markers)
Three years

Study Arms (1)

Cultivated limbal transplantation

EXPERIMENTAL

Procedure: Cultivated limbal transplantation

Interventions

Cultivated limbal transplantationProcedure

Cultivated corneal epithelial stem cell transplantation. Autograft, Living related allograft, and Cadaveric allograft

Cultivated limbal transplantation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Mahidol University
Otherlead

Study Sites (1)

Pinnita Prabhasawat, MD

Bangkok, 10300, Thailand

Study Officials

Pinnita Prabhasawat, MD
Mahidol University
PRINCIPAL INVESTIGATOR

Enrollment

19 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 9, 2010

Study Start

January 2008

Date type not reported

This date has not been verified as actual or estimated.

Age under 18

Active ocular infection, Severe dry eye, Uncontrolled glaucoma

Immunocompromised host

Pregnancy

Contact the study team to confirm eligibility.

Primary Completion

April 2011

Actual (reported)

Study Completion

November 2011

Actual (reported)

Last Updated

December 7, 2011

Record last verified: 2011-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01237600
Data provider: ClinicalTrials.gov
Source updated: 2011-12-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:11 UTC

Locations

TH(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Cultivated limbal transplantation

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations