Comparison of Epitheliotrophic Ability Between Human Serum and Commercialized Human Platelet- Cell and Animal Model Clinical Trial
Official title:
The Effect of Platelet Lysate on Corneal Epithelial Wound healing---the Collection of Human Serum From Volunteers
"Poor corneal epithelialization problem" can be found in a lot of ocular surface disorders,
including limbal insufficiency, dry eye, chemical burn and neurotrophic disorders. Delayed
corneal epithelialization under any circumstances can lead to corneal infection, corneal
melting, corneal opacity, pain or blurred vision. It is thus important to develop
pharmacological methods to promote corneal epithelial wound healing in those patients.
Previously, various epitheliotrophic growth factors, autologous serum, cord blood serum,
etc. have been proved to be effective in promoting corneal epithelial wound healing.
However, those topical agents have the drawbacks including the difficulties during
preparation, expensive price, non-standardized quality and the risk of contamination during
preparation. It will be clinically important to find other blood derivatives which are
effective, convenient for use, stable in quality and being cheap.
During the recent few years, various" platelet related blood derivatives" have been proved
to contain a lot of epitheliotrophic growth factors, and can promote wound healing. Among
those products, "platelet lysate" has the benefits of being commercially available. It can
avoid the complicated producing procedure, and has stable quality. Although platelet lysate
has been widely used in various medical fields, especially in culturing mesenchymal stem
cells, its potential in promoting corneal epithelial wound healing has not been proven. The
purpose of this project is to explore the possibility of using platelet lysate to treat
patients with poor corneal epithelialization problem, and compare its epitheliotrophic
ability with other blood derivatives. The cultured human corneal epithelial cell line will
be used for all experiments, and will be cultured with media containing different blood
products: (1) control group without blood derivatives, (2) fetal bovine serum, (3) human
serum, (4) platelet lysate commercial product—UltraGro, (5)platelet lysate commercial
product---PlatMax. MTS assay will be used to measure proliferation ability. "Scratch-induced
directional wounding assay" and "Boyden chamber chemotaxis assa" will be used to measure
cell migration. Scanning electron microscopy, transmission electron microscopy,
transepithelial electric resistance (TEER) and immunohistochemistry with junctional proteins
will be used to measure cellular differentiation. Through these experiments, the
investigator aim to understand whether platelet lysate can replace other blood derivatives,
and be used for treating patients with corneal epithelialization problem.
Beside, current medications in dry eye are all manufactured, transported and used in the
form of liquid form. However, it is more disturbing in transporting, commercializing,
storing and the limitation of expiration date for current medications compared with powder
form medications. Therefore, improving the convenience of utilizing and storage without at
the expense of the efficacy of blood-derivatives has become a critical issue. Our study also
aimed at trying to produce platelet-related derivatives (including platelet lysate) and
human serum into the form of dry powder and resuspended it with preservative-free artificial
tears. The investigator would compare the epitheliotrophic ability of the liquid form of
blood derivatives and the powder form of blood derivatives.
Since human serum is needed for comparison , the investigator proposed this IRB to collect
human serum from healthy volunteers。
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 50 Years |
Eligibility |
- Healthy volunteer control without ocular surface disease or prior ophthalmic surgery
history - Healthy volunteer without any other systemic disease taking longterm medication |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The purpose of this project is to collect the human serum as a control group, | The purpose of this project is to collect the human serum as a control group, and to explore the possibility of using "platelet lysate" to treat patients with poor corneal epithelialization problem, and compare its epitheliotrophic ability with other blood derivatives. Besides, the investigator would also compared the efficacy of dry powder of platelet lysate and other blood derivatives. The cultured human corneal epithelial cell line will be used for all experiments, and will be cultured with media containing different blood products: control group without blood derivatives, fetal bovine serum, human peripheral blood serum platelet lysate commercial product—UltraGro platelet lysate commercial product---PlatMax. the dry powder of human peripheral blood serum resuspended with artificial tear The investigator will evaluate the effects of these blood derivatives. |
1 year | No |