Comparison of Epitheliotrophic Ability Between Human Serum and Commercialized Human Platelet- Cell and Animal ModelNCT02720146
The Effect of Platelet Lysate on Corneal Epithelial Wound healing---the Collection of Human Serum From Volunteers
An observational study of Comparison of Epitheliotrophic Ability Between Human Serum and Commercialized Human Platelet- Cell and Animal Model, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
"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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparison of Epitheliotrophic Ability Between Human Serum and Commercialized Human Platelet- Cell and Animal Model
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Acquired whole blood for human serum used for wound healing array
- Healthy volunteer control without ocular surface disease or prior ophthalmic surgery history
- Healthy volunteer without any other systemic disease taking longterm medication
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Taipei
Wei-Li Chen, 886-972651537, chenweili@ntu.edu.tw
About this study
"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.
Read more
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。
- Keywords
- Dry eye
- Medical subject headings
- Disease Models, Animal, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Artificital tear | The epitheliotrophic ability in cell and animal model | |
| Human peripheral serum | The epitheliotrophic ability in cell and animal model | |
| Human platelet lysate | The epitheliotrophic ability in cell and animal model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of Epitheliotrophic Ability Between Human Serum and Commercialized Human Platelet- Cell and Animal ModelStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Chen, Principal investigator, National Taiwan University, Ophthalmologic Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720146
- Sponsor's protocol ID
- 201510123RINB
- Status last verified
- May 2016
- First submitted
- 21 Mar 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet Lysate on Corneal Epithelial Wound healing---the Collection of Human Serum From Volunteers
- ClinicalTrials.gov ID
- NCT02720146
- Acronym / sponsor ID
- 201510123RINB
- Keywords
- Dry eye
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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。
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Artificital tear | – | –The epitheliotrophic ability in cell and animal model |
| Human peripheral serum | – | –The epitheliotrophic ability in cell and animal model |
| Human platelet lysate | – | –The epitheliotrophic ability in cell and animal model |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Acquired whole blood for human serum used for wound healing array
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The purpose of this project is to collect the human serum as a control group,
Time frame: 1 year
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: 1. control group without blood derivatives, 2. fetal bovine serum, 3. human peripheral blood serum 4. platelet lysate commercial product-UltraGro 5. platelet lysate commercial product---PlatMax. 6. the dry powder of human peripheral blood serum resuspended with artificial tear The investigator will evaluate the effects of these blood derivatives.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Li Chen principal investigator
National Taiwan University, Ophthalmologic Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comparison of Epitheliotrophic Ability Between Human Serum and Commercialized Human Platelet- Cell and Animal Model, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 建融 黃 (886-958834977, b95401068@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The purpose of this project is to collect the human serum as a control group, (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.