Corneal Epithelial Wound Healing Difference Between Human Autoserum and Cord Blood Serum
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
1 other identifier
observational
7
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2007
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedJanuary 10, 2011
December 1, 2010
1 year
May 19, 2008
January 6, 2011
Conditions
Keywords
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
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
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: 12410036BACKGROUNDFox 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: 6712760BACKGROUNDGeerling 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: 15489495BACKGROUNDGoto 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: 11685056BACKGROUNDPoon 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: 11567963BACKGROUNDTsubota 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: 10434857BACKGROUNDTsubota 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: 10519596BACKGROUNDTsubota 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: 11064861BACKGROUNDTsubota 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: 8659597BACKGROUNDTsubota 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: 10577524BACKGROUNDYoon 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: 16209277BACKGROUNDYoon 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: 16633024BACKGROUNDYoung 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
- PRINCIPAL INVESTIGATOR
Wei-Li Chen, MD, PhD
National Taiwan University Hospital, department of Ophthalmology
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