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Corneal Epithelial Wound Healing Difference Between Human Autoserum and Cord Blood Serum

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681642
First Posted: May 21, 2008
Last Update Posted: January 10, 2011
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:
National Taiwan University Hospital
  Purpose
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.

Condition
Corneal Epithelial Wound Healing

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phase 1 Study of Comparison of the Effects on Promoting Corneal Epithelial Wound Healing Between Human Autoserum and Cord Blood Serum—in Vitro Cell Culture Experiment

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Cell proliferation [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Cell migration [ Time Frame: 1 week ]

Enrollment: 7
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Corneal epithelial tissue with wound cultured in human autoserum
2
Corneal epithelial tissue with wound cultured in umbilical cord serum

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy pregnant women underwent smooth cesarean section during labor Healthy blood donor
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • The retained placenta and umbilical cord were not complete
  • Individual with anemia or other hematologic disorder unsuitable for blood donation
  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): NCT00681642


Locations
Taiwan
National Taiwan University Hospital, department of Ophthalmology
Taipei, Taiwan, 10047
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wei-Li Chen, MD, PhD National Taiwan University Hospital, department of Ophthalmology
  More Information

Publications:
del Castillo JM, de la Casa JM, Sardiña RC, Fernández RM, Feijoo JG, Gómez AC, Rodero MM, Sánchez JG. Treatment of recurrent corneal erosions using autologous serum. Cornea. 2002 Nov;21(8):781-3.
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.
Geerling G, Maclennan S, Hartwig D. Autologous serum eye drops for ocular surface disorders. Br J Ophthalmol. 2004 Nov;88(11):1467-74. Review.
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.
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.
Tsubota K, Goto E, Fujita H, Ono M, Inoue H, Saito I, Shimmura S. Treatment of dry eye by autologous serum application in Sjögren's syndrome. Br J Ophthalmol. 1999 Apr;83(4):390-5.
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.
Tsubota K, Higuchi A. Serum application for the treatment of ocular surface disorders. Int Ophthalmol Clin. 2000 Fall;40(4):113-22. Review.
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.
Tsubota K, Shimazaki J. Surgical treatment of children blinded by Stevens-Johnson syndrome. Am J Ophthalmol. 1999 Nov;128(5):573-81.
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.
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.
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.

Responsible Party: Wei-Li Chen, MD, PhD, Assistant Professor, National Taiwan University Hospital, department of Ophthalmology
ClinicalTrials.gov Identifier: NCT00681642     History of Changes
Other Study ID Numbers: 200702037R
First Submitted: May 19, 2008
First Posted: May 21, 2008
Last Update Posted: January 10, 2011
Last Verified: December 2010

Keywords provided by National Taiwan University Hospital:
Corneal epithelial wound
Human autoserum
Cord blood

Additional relevant MeSH terms:
Wounds and Injuries


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