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
Sponsor study identifier
observational
7
1 country
1
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)Study Completion
March 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
March 2008
Actual (reported)March 2008
Actual (reported)May 19, 2008
Actual (reported)May 21, 2008
Actual (reported)Cell proliferation
1 week
Cell migration
1 week
Corneal epithelial tissue with wound cultured in human autoserum
Corneal epithelial tissue with wound cultured in umbilical cord serum
Healthy pregnant women underwent smooth cesarean section during labor Healthy blood donor
National Taiwan University Hospital, department of Ophthalmology
Taipei, 10047, Taiwan
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.
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.
Wei-Li Chen, MD, PhD
National Taiwan University Hospital, department of Ophthalmology
7 participants (actual enrollment reported by the registry).
First Submitted
May 19, 2008
First Posted
May 21, 2008
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Cross-linked CMC and Silk Proteins in Corneal Re-epithelization
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
March 2008
Actual (reported)Study Completion
March 2008
Actual (reported)Last Updated
January 10, 2011
Record last verified: 2010-12
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