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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548261
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
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.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
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 Intervention
Healthy Procedure: Donating oral mucosal cells

Study Type: Observational
Study Design: Observational Model: Case-Only

Further study details as provided by National Taiwan University Hospital:

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

Estimated Enrollment: 1
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Health people. Procedure: Donating oral mucosal cells
Donating oral mucosal cells

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01548261


Contacts
Contact: Wei Li Chen, MD, PhD 886-2-23123456 ext 65206 chenweili@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital, department of Ophthalmology Recruiting
Taipei, Taiwan, 100
Contact: Wei Li Chen, MD, PhD    886-2-23123456 ext 65206    chenweili@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital, Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology.
ClinicalTrials.gov Identifier: NCT01548261     History of Changes
Other Study ID Numbers: 201110051RB
First Submitted: March 5, 2012
First Posted: March 8, 2012
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