NCT01808495

Brief Summary

The purpose of this study is to investigate the role of nuclear Fibulin-1 (FBLN1) in Human Corneal Fibroblasts under treatment of mitomycin C (MMC).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

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

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 11, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

September 13, 2012

Last Update Submit

August 10, 2015

Conditions

Keywords

Human corneal fibroblastsFibulin-1Nuclear accumulation

Outcome Measures

Primary Outcomes (1)

  • Modification of nuclear Fibulin-1 accumulation in suppressing gene expression

    3 days post mitomycin C treatment

Interventions

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The original cell sources were collected from the donors with more than 20 years old following penetrating keratoplasty. After successfully amplified from the residual corneal rim following penetrating keratoplasty in the previous projects, human corneal fibroblasts (HCFs) were reserved in liquid nitrogen tank and were thawed for this study under in vitro cultivation and application.

You may qualify if:

  • The frozen storage cells in liquid nitrogen were amplified from the residual corneal rim of the donors with more than 20 years old following penetrating keratoplasty.

You may not qualify if:

  • The donors were younger than 20 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Mitomycin

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Tsan-Chi Chen, PhD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Ophthalmology

Study Record Dates

First Submitted

September 13, 2012

First Posted

March 11, 2013

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08