Corneal Epithelial Wound Healing Difference Between Human Autoserum and Cord Blood Serum - Full Text View

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00681642

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, 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

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

Cell proliferation [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cell migration [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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. No abstract available.

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, 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. 2004 Jun;18(6):609-14.

Responsible Party:	National Taiwan University Hospital, department of Ophthalmology ( Wei-Li Chen, MD, PhD, Assistant Professor )
Study ID Numbers:	200702037R
Study First Received:	May 19, 2008
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00681642
Health Authority:	Taiwan: Department of Health; Taiwan: Institutional Review Board; Taiwan: National Bureau of Controlled Drugs

Keywords provided by National Taiwan University Hospital:

Corneal epithelial wound
Human autoserum
Cord blood

ClinicalTrials.gov processed this record on January 14, 2009