Donating Oral Mucosal Cells for the Study of ex Vivo Culture of Cells Sheets
1 other identifier
observational
1
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2012
Longer than P75 for all trials
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
March 5, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 8, 2012
March 1, 2012
3.9 years
March 5, 2012
March 7, 2012
Conditions
Keywords
Study Arms (1)
Health people.
Interventions
Eligibility Criteria
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
Biospecimen
Donating oral mucosal cells for the study of ex vivo culture of cells sheets.
Central Study Contacts
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