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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

Other trials in Taiwan

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 groups in NCT02720146
Study groupRoleWhat they receive
Artificital tearThe epitheliotrophic ability in cell and animal model
Human peripheral serumThe epitheliotrophic ability in cell and animal model
Human platelet lysateThe epitheliotrophic ability in cell and animal model

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

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)
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

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.

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