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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00681642
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Epithelial Wound Healing

Study Design

• Study Type: Observational
• Actual Enrollment: 7 participants
• 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
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1 Corneal epithelial tissue with wound cultured in human autoserum
2 Corneal epithelial tissue with wound cultured in umbilical cord serum

Outcome Measures

Primary Outcome Measures

1. Cell proliferation [1 week]

Secondary Outcome Measures

1. Cell migration [1 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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.

• ClinicalTrials.gov Identifier: NCT00681642
• Other Study ID Numbers: 200702037R
• First Posted: May 21, 2008
• Last Update Posted: Jan 10, 2011
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Corneal epithelial wound; Human autoserum; Cord blood
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Jan 10, 2011