NCT01942421

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 16, 2013

Status Verified

September 1, 2013

Enrollment Period

5.4 years

First QC Date

December 6, 2011

Last Update Submit

September 10, 2013

Conditions

Ocular Surface Disease

Keywords

Limbal deficiencyCultivated limbal transplantationEx vivo limbal transplantationCultivated autologous mucosal epithelial transplantation

Outcome Measures

Primary Outcomes (1)

  • Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery

    Three years

Study Arms (1)

Cultivated mucosal epithelial transplant

EXPERIMENTAL

Cultivated mucosal epithelial transplantaion to limbal deficiency patients

Procedure: Cultivated mucosal epithelial transplantation

Interventions

Cultivated mucosal epithelial transplantationPROCEDURE

cultivated autologous mucosal epithelium, then transplant to limbal stem cell deficiency patients.

Cultivated mucosal epithelial transplant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pinnita Prabhasawat, MD

Bangkok, Thailand, 10300, Thailand

Location

Study Officials

  • Pinnita Prabhasawat, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

December 6, 2011

First Posted

September 16, 2013

Study Start

January 1, 2008

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

September 16, 2013

Record last verified: 2013-09

Locations

TH(1)