NCT00681642

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
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
Last Updated

January 10, 2011

Status Verified

December 1, 2010

Enrollment Period

1 year

First QC Date

May 19, 2008

Last Update Submit

January 6, 2011

Conditions

Keywords

Corneal epithelial woundHuman autoserumCord blood

Outcome Measures

Primary Outcomes (1)

  • Cell proliferation

    1 week

Secondary Outcomes (1)

  • Cell migration

    1 week

Study Arms (2)

1

Corneal epithelial tissue with wound cultured in human autoserum

2

Corneal epithelial tissue with wound cultured in umbilical cord serum

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy pregnant women underwent smooth cesarean section during labor Healthy blood donor

You may qualify if:

  • Healthy pregnant women
  • Cesarean section for labor
  • Complete placenta with umbilical cord retained
  • Healthy individual

You may not qualify if:

  • The retained placenta and umbilical cord were not complete
  • Individual with anemia or other hematologic disorder unsuitable for blood donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, department of Ophthalmology

Taipei, 10047, Taiwan

Location

Related Publications (13)

  • del Castillo JM, de la Casa JM, Sardina RC, Fernandez RM, Feijoo JG, Gomez AC, Rodero MM, Sanchez JG. Treatment of recurrent corneal erosions using autologous serum. Cornea. 2002 Nov;21(8):781-3. doi: 10.1097/00003226-200211000-00010.

    PMID: 12410036BACKGROUND
  • Fox RI, Chan R, Michelson JB, Belmont JB, Michelson PE. Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca. Arthritis Rheum. 1984 Apr;27(4):459-61. doi: 10.1002/art.1780270415. No abstract available.

    PMID: 6712760BACKGROUND
  • Geerling G, Maclennan S, Hartwig D. Autologous serum eye drops for ocular surface disorders. Br J Ophthalmol. 2004 Nov;88(11):1467-74. doi: 10.1136/bjo.2004.044347.

    PMID: 15489495BACKGROUND
  • Goto E, Shimmura S, Shimazaki J, Tsubota K. Treatment of superior limbic keratoconjunctivitis by application of autologous serum. Cornea. 2001 Nov;20(8):807-10. doi: 10.1097/00003226-200111000-00006.

    PMID: 11685056BACKGROUND
  • Poon AC, Geerling G, Dart JK, Fraenkel GE, Daniels JT. Autologous serum eyedrops for dry eyes and epithelial defects: clinical and in vitro toxicity studies. Br J Ophthalmol. 2001 Oct;85(10):1188-97. doi: 10.1136/bjo.85.10.1188.

    PMID: 11567963BACKGROUND
  • Tsubota K, Goto E, Fujita H, Ono M, Inoue H, Saito I, Shimmura S. Treatment of dry eye by autologous serum application in Sjogren's syndrome. Br J Ophthalmol. 1999 Apr;83(4):390-5. doi: 10.1136/bjo.83.4.390.

    PMID: 10434857BACKGROUND
  • Tsubota K, Goto E, Shimmura S, Shimazaki J. Treatment of persistent corneal epithelial defect by autologous serum application. Ophthalmology. 1999 Oct;106(10):1984-9. doi: 10.1016/S0161-6420(99)90412-8.

    PMID: 10519596BACKGROUND
  • Tsubota K, Higuchi A. Serum application for the treatment of ocular surface disorders. Int Ophthalmol Clin. 2000 Fall;40(4):113-22. doi: 10.1097/00004397-200010000-00009. No abstract available.

    PMID: 11064861BACKGROUND
  • Tsubota K, Satake Y, Ohyama M, Toda I, Takano Y, Ono M, Shinozaki N, Shimazaki J. Surgical reconstruction of the ocular surface in advanced ocular cicatricial pemphigoid and Stevens-Johnson syndrome. Am J Ophthalmol. 1996 Jul;122(1):38-52. doi: 10.1016/s0002-9394(14)71962-2.

    PMID: 8659597BACKGROUND
  • Tsubota K, Shimazaki J. Surgical treatment of children blinded by Stevens-Johnson syndrome. Am J Ophthalmol. 1999 Nov;128(5):573-81. doi: 10.1016/s0002-9394(99)00224-x.

    PMID: 10577524BACKGROUND
  • Yoon KC, Heo H, Jeong IY, Park YG. Therapeutic effect of umbilical cord serum eyedrops for persistent corneal epithelial defect. Korean J Ophthalmol. 2005 Sep;19(3):174-8. doi: 10.3341/kjo.2005.19.3.174.

    PMID: 16209277BACKGROUND
  • Yoon KC, Im SK, Park YG, Jung YD, Yang SY, Choi J. Application of umbilical cord serum eyedrops for the treatment of dry eye syndrome. Cornea. 2006 Apr;25(3):268-72. doi: 10.1097/01.ico.0000183484.85636.b6.

    PMID: 16633024BACKGROUND
  • Young AL, Cheng AC, Ng HK, Cheng LL, Leung GY, Lam DS. The use of autologous serum tears in persistent corneal epithelial defects. Eye (Lond). 2004 Jun;18(6):609-14. doi: 10.1038/sj.eye.6700721.

    PMID: 15184926BACKGROUND

Study Officials

  • Wei-Li Chen, MD, PhD

    National Taiwan University Hospital, department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

March 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

January 10, 2011

Record last verified: 2010-12

Locations