NCT01548261

Brief Summary

Cultivated oral mucosal epithelial sheets on amniotic membrane have been reported to have good clinical results in treating patients with ocular surface disorders in both human and animal studies. However, such technique has not been well established in this hospital. The main purpose of this study is to obtain the discarded oral mucosal tissue from healthy donors who volunteer to donate their oral mucosa from buccal area. The obtained oral mucosal tissue will be cultured under different types (co-culture with or without 3T3 cells)。Inverted light microscopy, electron microscopy and immunostaining with K3/K12, K14, Ki67, P63, connexin 43, and involucrin will be preformed to test the effects of foreskin cell line co-culture system on cell condition. The investigators plan to start the study from Jan. 1st, 2011 to Dec. 31th, 2015. Thirty patients will be enrolled.

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
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

3.9 years

First QC Date

March 5, 2012

Last Update Submit

March 7, 2012

Conditions

Keywords

obtain the oral mucosal tissue from healthy donors

Study Arms (1)

Health people.

Procedure: Donating oral mucosal cells

Interventions

Donating oral mucosal cells

Health people.

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Health people.

You may qualify if:

  • The age 20 to 55 year-old healthy contributor.
  • does not have disease of the oral cavity.

You may not qualify if:

  • In the past had the oral mucosa disease, wound cicatrization bad, or hemoglutination condition not good medical history. Sickness must stop using above any anti-hemoglutination medicine one week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, department of Ophthalmology

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Donating oral mucosal cells for the study of ex vivo culture of cells sheets.

Central Study Contacts

Wei Li Chen, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology.

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 8, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations