Severe Ocular Surface DamagePhase 2/3NCT01237600
Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction
A Phase 2/3 study testing Cultivated limbal transplantation in people with Severe Ocular Surface Damage and Limbal Deficiency, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to elucidate the appropriate condition of developing cultivated corneal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated corneal epithelial stem cell in the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Ocular Surface Damage, Limbal Deficiency
- What is being tested?
- Cultivated limbal transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2008to Nov 2011
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral/Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology result
Who cannot join
- Age under 18
- Active ocular infection, Severe dry eye, Uncontrolled glaucoma
- Immunocompromised host
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to elucidate the appropriate condition of developing cultivated corneal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated corneal epithelial stem cell in the patients.
Read the detailed description
Ocular surface damage caused by severe ocular surface diseases, particularly thermal and chemical burn or Stevens-Johnson syndrome result in corneal epithelial defect, corneal vascularization, corneal conjunctivalization and loss of transparency. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications.
- Conditions
- Severe Ocular Surface Damage, Limbal Deficiency
- Being tested
- Cultivated limbal transplantation
- Keywords
- Ocular surface damage, Limbal deficiency, Cultivated corneal epithelial stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultivated limbal transplantationProcedure or surgery
Cultivated corneal epithelial stem cell transplantation. Autograft, Living related allograft, and Cadaveric allograft
| Study group | Role | What they receive |
|---|---|---|
| Cultivated limbal transplantation | Experimental | Not described Receives: Procedure: Cultivated limbal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface status (signs of limbal deficiency and immunopathological markers)
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startJan 2008
- Primary completionApr 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Ocular Surface DamageStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinnita Prabhasawat, Mahidol University
- Investigators
- Pinnita Prabhasawat, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237600
- Sponsor's protocol ID
- 447/2550(EC2)
- Status last verified
- Dec 2011
- First submitted
- 8 Nov 2010
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction
- ClinicalTrials.gov ID
- NCT01237600
- Acronym / sponsor ID
- 447/2550(EC2)
- Conditions
- Severe Ocular Surface Damage, Limbal Deficiency
- Keywords
- Ocular surface damage, Limbal deficiency, Cultivated corneal epithelial stem cell transplantation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 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.
The purpose of this study is to elucidate the appropriate condition of developing cultivated corneal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated corneal epithelial stem cell in the patients.
Detailed description
Ocular surface damage caused by severe ocular surface diseases, particularly thermal and chemical burn or Stevens-Johnson syndrome result in corneal epithelial defect, corneal vascularization, corneal conjunctivalization and loss of transparency. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cultivated limbal transplantation | Experimental | Procedure: Cultivated limbal transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral/Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology result
Key exclusion criteria (4 listed)
- Age under 18
- Active ocular infection, Severe dry eye, Uncontrolled glaucoma
- Immunocompromised host
- 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 |
|---|---|---|
| Cultivated limbal transplantationCultivated corneal epithelial stem cell transplantation. Autograft, Living related allograft, and Cadaveric allograft | Procedure or surgery | Cultivated limbal transplantation |
Primary outcome
Ocular surface status (signs of limbal deficiency and immunopathological markers)
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2011.
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.
Pinnita Prabhasawat, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cultivated limbal transplantation in people with Severe Ocular Surface Damage and Limbal Deficiency, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 7 Dec 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 Thailand. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ocular surface status (signs of limbal deficiency and immunopathological markers) (time frame: Three years). 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 7 Dec 2011.