Porcine Corneal XenographPhase 1XKFPCNCT01443559
Xenogenic Keratoplasty From Porcine Cornea
A Phase 1 study testing Xenogenic cornea and homogenic cornea in people with Porcine Corneal Xenograph, run by Xiamen University at 1 site in China.
Trial summary
Acellular porcine cornea is a valid substitution for human cornea because of its similar biological structure, corneal superficial curvature and good histocompatibility toward human. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Porcine Corneal Xenograph
- What is being tested?
- Xenogenic cornea and homogenic cornea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Dec 2015
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with severe infectious corneal ulcer
- The ulcers can not be controlled with existing antibiotics eye drops or medicine after 1 week treatment
- The infected corneas have risks of penetrating
- The depth of ulcers are less than 400um
- The bridge of the ulcers is away from corneal limbal more than 1mm
- Patients aged 18 or older
- Patients able and willing to sign the informed consent form
Who cannot join
- Patients with severe infectious corneal ulcer in stable stage
- Patients with corneal ulcers after viruses infection, such as herpes simplex virus
- Patients with corneal ulcers from non-infectious factors, such as toxicity, burn or immunological inflammation
- The ulcers are not cover pupil zone and will not result in visional defect in future
- The depth of ulcer is less than 50um
- Patients has history of keratoplasty surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Xiamen University Affiliated Xiamen Eye Center
Xiamen, Fujian, 361005
About this study
Official title: Phase I Study of Xenogenic Keratoplasty From Porcine Cornea in the Treatment of Infectious Corneal Ulcer
Acellular porcine cornea is a valid substitution for human cornea because of its similar biological structure, corneal superficial curvature and good histocompatibility toward human. Facing the lack of human cornea donor, it is hypothesised that using acellular lamellar porcine cornea as an alternative of lamellar human cornea to treat infectious corneal ulcer.
Read the detailed description
Acellular porcine cornea eligibility criteria:
- fresh porcine cornea,
- porcine cornea keeping transparent without scar, neovascularization or corneal ulcer,
- porcine cornea keeping integrative corneal epithelium and endothelium,
- acellular porcine cornea keeping transparent.
- Conditions
- Porcine Corneal Xenograph
- Being tested
- Xenogenic cornea, homogenic cornea
- Keywords
- Xenogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenogenic corneaGenetic
lamellar acellular xenogenic corneas were sterilised by radiation
homogenic corneaGenetic
homogenic corneas were sterilised by radiation
| Study group | Role | What they receive |
|---|---|---|
| Xenogenic cornea | Experimental | Not described Receives: Genetic: Xenogenic cornea |
| human cornea | Active comparator | Not described Receives: Genetic: homogenic cornea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rejection in three months after keratoplasty
- Rate of epithelium rejection Epithelial rejection performances: 1.1 epithelium edema, OR 1.2 epithelium opacity, OR 1.3 epithelial rejection line.
- Rate of stroma rejection Stroma rejection performances: 2.1 stroma edema, OR 2.2 stroma opacity, OR 2.3 suture loosing.
Measured: three months after lamellar keratoplasty
Secondary outcomes (1)
Density of regenerative sub-epithelial nerve plex, stromal nerve and stromal keratocytes in vivo confocal microscopy
Shapes and location:
- Sub-epithelial nerve plex is in the depth between 35um to 65um shaping like white thin line with branches in vivo confocal microscopy.
- Sromal nerve is in the stromal layer(about 70um to 500um) shaping like white thick trunk with branches in vivo confocal microscopy.
- Stromal keratocytes is in the stromal layer like white rod-shape in vivo confocal microscopy.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: there was not enough patients recruited in this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Porcine Corneal XenographStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zuguo Liu, Xiamen University
- Investigators
- Zuguo Liu, PhD, Study director, Eye Institute of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443559
- Sponsor's protocol ID
- EIXM-XKFPC-20110901
- Acronym
- XKFPC
- Status last verified
- Jul 2015
- First submitted
- 19 Sep 2011
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Xenogenic Keratoplasty From Porcine Cornea in the Treatment of Infectious Corneal Ulcer
- ClinicalTrials.gov ID
- NCT01443559
- Acronym / sponsor ID
- XKFPC / EIXM-XKFPC-20110901
- Conditions
- Porcine Corneal Xenograph
- Keywords
- Xenogenic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: there was not enough patients recruited in this study
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 Sep 2011 (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.
Acellular porcine cornea is a valid substitution for human cornea because of its similar biological structure, corneal superficial curvature and good histocompatibility toward human. Facing the lack of human cornea donor, it is hypothesised that using acellular lamellar porcine cornea as an alternative of lamellar human cornea to treat infectious corneal ulcer.
Detailed description
Acellular porcine cornea eligibility criteria:
- fresh porcine cornea,
- porcine cornea keeping transparent without scar, neovascularization or corneal ulcer,
- porcine cornea keeping integrative corneal epithelium and endothelium,
- acellular porcine cornea keeping transparent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenogenic cornea | Experimental | Genetic: Xenogenic cornea |
| human cornea | Active comparator | Genetic: homogenic cornea |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with severe infectious corneal ulcer
- The ulcers can not be controlled with existing antibiotics eye drops or medicine after 1 week treatment
- The infected corneas have risks of penetrating
- The depth of ulcers are less than 400um
- The bridge of the ulcers is away from corneal limbal more than 1mm
Key exclusion criteria (6 listed)
- Patients with severe infectious corneal ulcer in stable stage
- Patients with corneal ulcers after viruses infection, such as herpes simplex virus
- Patients with corneal ulcers from non-infectious factors, such as toxicity, burn or immunological inflammation
- The ulcers are not cover pupil zone and will not result in visional defect in future
- The depth of ulcer is less than 50um
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 |
|---|---|---|
| Xenogenic cornealamellar acellular xenogenic corneas were sterilised by radiation | Genetic | Xenogenic cornea |
| homogenic corneahomogenic corneas were sterilised by radiation | Genetic | human cornea |
Primary outcome
Rate of rejection in three months after keratoplasty
Time frame: three months after lamellar keratoplasty
1. Rate of epithelium rejection Epithelial rejection performances: 1.1 epithelium edema, OR 1.2 epithelium opacity, OR 1.3 epithelial rejection line. 2. Rate of stroma rejection Stroma rejection performances: 2.1 stroma edema, OR 2.2 stroma opacity, OR 2.3 suture loosing.
1 secondary outcome
Density of regenerative sub-epithelial nerve plex, stromal nerve and stromal keratocytes in vivo confocal microscopy
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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.
Zuguo Liu, PhD study director
Eye Institute of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xenogenic cornea and homogenic cornea in people with Porcine Corneal Xenograph, run by Xiamen University 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 7 inclusion and 6 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: paused, as of the sponsor's last update on 17 Jul 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of rejection in three months after keratoplasty (time frame: three months after lamellar keratoplasty). 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 17 Jul 2015.