Corneal UlcerNCT01244776
Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer
A study testing acellular corneal matrix in people with Corneal Ulcer, run by Shaanxi Aierfu Activtissue Engineering at 1 site in China.
Trial summary
This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Corneal Ulcer
- What is being tested?
- acellular corneal matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Jul 2012
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 75 yrs.
- Corneal ulcer.
- Informed consent.
Who cannot join
- Corneal perforation.
- Other ocular diseases.
- The presence of systemic connective tissue diseases
- Severe allergic constitution
- Pregnancy
- The presence of chronic disease, such as significant cardiovascular illness
- The patients who received clinical experiments for other medicine or medical devices within 3 months prior to the transplantation.
- Any patient that is not suitable for recruitment, in the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Liuhe Zhou
About this study
This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.
Read the detailed description
Infections, chemical injury, and other diseases result in acute or chronic corneal ulcer, which may damage corneal stroma and may lead to permanent corneal scars and blindness. Corneal transplantation is standard method for corneal ulcer, but severe shortage of donor corneas limits its application. Acellular porcine corneal matrix is similar to the native cornea, especially with the biological property and microstructure. Recently, this matrix has been proved to be safe when transplanted to animal subjects and will not be rejected by the recipient. In animal lamellar keratoplasty experiments, acellular corneal matrix showed that they can integrate into the corneal wound bed and help reconstruction of the lamellar integrity of corneal stroma. This study will investigate its healing effect on human corneal ulcer. It will provide a potential corneal substitute for this disease.
- Conditions
- Corneal Ulcer
- Being tested
- acellular corneal matrix
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acellular corneal matrixDevice
Also called ACM
Efficacy of acellular corneal matrix to restore stroma integrity and treat corneal ulcer after lamellar keratoplasty.
| Study group | Role | What they receive |
|---|---|---|
| Acellular corneal matrix | Experimental | Not described Receives: Device: acellular corneal matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rejection evaluation
Measured: 30 days following transplantation
Secondary outcomes (1)
Corneal wound healing
Measured: 90 days following transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal UlcerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Aierfu Activtissue Engineering
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen AiNear Cornea Engineering Company Limited, Air Force Military Medical University, China, Engineering Technology Center for Tissue Engineering of Xi'an, Beijing Tongren Hospital, West China Hospital, Henan Provincial People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Southwest Hospital, China
- Investigators
- Liuhe Zhou, M.D., Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244776
- Sponsor's protocol ID
- TEC 01
- Status last verified
- May 2011
- First submitted
- 18 Nov 2010
- Last updated
- 6 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer
- ClinicalTrials.gov ID
- NCT01244776
- Acronym / sponsor ID
- TEC 01
- Conditions
- Corneal Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shaanxi Aierfu Activtissue EngineeringIndustry (pharma, biotech, devices)
- Collaborators
- Shenzhen AiNear Cornea Engineering Company Limited, Air Force Military Medical University, China, Engineering Technology Center for Tissue Engineering of Xi'an, Beijing Tongren Hospital, West China Hospital, Henan Provincial People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Southwest Hospital, China
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 19 Nov 2010 (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.
This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.
Detailed description
Infections, chemical injury, and other diseases result in acute or chronic corneal ulcer, which may damage corneal stroma and may lead to permanent corneal scars and blindness. Corneal transplantation is standard method for corneal ulcer, but severe shortage of donor corneas limits its application. Acellular porcine corneal matrix is similar to the native cornea, especially with the biological property and microstructure. Recently, this matrix has been proved to be safe when transplanted to animal subjects and will not be rejected by the recipient. In animal lamellar keratoplasty experiments, acellular corneal matrix showed that they can integrate into the corneal wound bed and help reconstruction of the lamellar integrity of corneal stroma. This study will investigate its healing effect on human corneal ulcer. It will provide a potential corneal substitute for this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acellular corneal matrix | Experimental | Device: acellular corneal matrix |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 75 yrs.
- Corneal ulcer.
- Informed consent.
Key exclusion criteria (8 listed)
- Corneal perforation.
- Other ocular diseases.
- The presence of systemic connective tissue diseases
- Severe allergic constitution
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acellular corneal matrixAlso: ACMEfficacy of acellular corneal matrix to restore stroma integrity and treat corneal ulcer after lamellar keratoplasty. | Device | Acellular corneal matrix |
Primary outcome
Rejection evaluation
Time frame: 30 days following transplantation
1 secondary outcome
Corneal wound healing
Time frame: 90 days following transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2011.
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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.
Liuhe Zhou, M.D. principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acellular corneal matrix in people with Corneal Ulcer, run by Shaanxi Aierfu Activtissue Engineering at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. 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 2011. 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 China. 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 Yongbo Lu (86-29-84776153, yongerbo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rejection evaluation (time frame: 30 days following transplantation). 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 2011.