Donating Oral Mucosal Cells for the Study of ex Vivo Culture of Cells Sheets

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01548261
Recruitment Status : Unknown
Verified March 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment
Healthy Procedure: Donating oral mucosal cells

Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Case-Only
Study Start Date : January 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Group/Cohort Intervention/treatment
Health people. Procedure: Donating oral mucosal cells
Donating oral mucosal cells

Biospecimen Retention:   Samples With DNA
Donating oral mucosal cells for the study of ex vivo culture of cells sheets.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Health people.

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01548261

Contact: Wei Li Chen, MD, PhD 886-2-23123456 ext 65206

National Taiwan University Hospital, department of Ophthalmology Recruiting
Taipei, Taiwan, 100
Contact: Wei Li Chen, MD, PhD    886-2-23123456 ext 65206   
Sponsors and Collaborators
National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital, Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology. Identifier: NCT01548261     History of Changes
Other Study ID Numbers: 201110051RB
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by National Taiwan University Hospital:
obtain the oral mucosal tissue from healthy donors