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

Corneal Epithelial Wound Healing Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681642
• Other study ID #: 200702037R
• Status: Completed
• Phase: N/A
• First received: May 19, 2008
• Last updated: January 6, 2011
• Start date: March 2007
• Est. completion date: March 2008

Study information

• Verified date: December 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthTaiwan: Institutional Review BoardTaiwan: National Bureau of Controlled Drugs
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Corneal Epithelial Wound Healing

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, department of Ophthalmology	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (13)

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. — View Citation

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. — View Citation

Geerling G, Maclennan S, Hartwig D. Autologous serum eye drops for ocular surface disorders. Br J Ophthalmol. 2004 Nov;88(11):1467-74. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Tsubota K, Higuchi A. Serum application for the treatment of ocular surface disorders. Int Ophthalmol Clin. 2000 Fall;40(4):113-22. Review. — View Citation

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. — View Citation

Tsubota K, Shimazaki J. Surgical treatment of children blinded by Stevens-Johnson syndrome. Am J Ophthalmol. 1999 Nov;128(5):573-81. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell proliferation		1 week	No
Secondary	Cell migration		1 week	No