NCT00598299

Brief Summary

Human serum eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing. Umbilical cord serum is also proven to be effective in treatment of dry eye and persistent corneal epithelial defects. However, there are limited studies comparing the corneal epithelial wound healing promoting effects between these two blood derived products. The purpose of this study is to test the corneal epithelial wound healing promoting effects between auto serum and human cord blood serum. Primary cultured bovine corneal epithelial cells were used as the model to investigate wound healing, cell proliferation and migration by means of scratch corneal wound healing assay evaluation, MTS assay and Boyden chamber migration assay in response to human serum and umbilical cord serum. The concentrations of EGF, TGF-β1, and fibronectin were also compared between human serum and umbilical cord serum with ELISA kits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 21, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

November 4, 2008

Status Verified

October 1, 2008

First QC Date

January 10, 2008

Last Update Submit

November 2, 2008

Conditions

Eye Injuries

Keywords

corneal epithelium

Study Arms (2)

A

Healthy adult serum

Procedure: venous punctureOther: obtain serum from perripheral blood or cord blood

B

cord blood serum

Procedure: venous punctureOther: obtain serum from perripheral blood or cord blood

Interventions

venous puncturePROCEDURE

venous puncture

AB
obtain serum from perripheral blood or cord bloodOTHER

obtain serum from perripheral blood or cord blood

AB

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

heahty adult volunteers and donated cord blood

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • unhealthy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Eye Injuries

Condition Hierarchy (Ancestors)

Facial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesEye DiseasesWounds and Injuries

Study Officials

  • Fung-Rong Hu, MD

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 21, 2008

Study Start

April 1, 2007

Study Completion

April 1, 2008

Last Updated

November 4, 2008

Record last verified: 2008-10

Locations

TW(1)