Ocular Surface DiseasePhase 2/3NCT01942421
Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation
A Phase 2/3 study testing Cultivated mucosal epithelial transplantation in people with Ocular Surface Disease, 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 autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Surface Disease
- What is being tested?
- Cultivated mucosal epithelial transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2008to Dec 2013
- 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
- Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology
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
Official title: Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation.
The purpose of this study is to elucidate the appropriate condition of developing cultivated autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients.
Read the detailed description
Ocular surface damage caused by severe ocular surface diseases. 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. Ocular surface reconstruction with cultivated autologous mucosal epithelial transplantation is served to improve the surgical results of ocular surface reconstruction and decrease the use of immunosuppressive medications
- Conditions
- Ocular Surface Disease
- Being tested
- Cultivated mucosal epithelial transplantation
- Keywords
- Limbal deficiency, Cultivated limbal transplantation, Ex vivo limbal transplantation, Cultivated autologous mucosal epithelial transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultivated mucosal epithelial transplantationProcedure or surgery
cultivated autologous mucosal epithelium, then transplant to limbal stem cell deficiency patients.
| Study group | Role | What they receive |
|---|---|---|
| Cultivated mucosal epithelial transplant | Experimental | Cultivated mucosal epithelial transplantaion to limbal deficiency patients Receives: Procedure: Cultivated mucosal epithelial transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery
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 posted16 Sep 2013 (estimated)
- Study startJan 2008
- Primary completionJun 2013
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies 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
- 20 participants (estimated)
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
- NCT01942421
- Sponsor's protocol ID
- 639/2551(EC2)
- Status last verified
- Sep 2013
- First submitted
- 6 Dec 2011
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation.
- ClinicalTrials.gov ID
- NCT01942421
- Acronym / sponsor ID
- 639/2551(EC2)
- Conditions
- Ocular Surface Disease
- Keywords
- Limbal deficiency, Cultivated limbal transplantation, Ex vivo limbal transplantation, Cultivated autologous mucosal epithelial transplantation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 16 Sep 2013 (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 autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients.
Detailed description
Ocular surface damage caused by severe ocular surface diseases. 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. Ocular surface reconstruction with cultivated autologous mucosal epithelial transplantation is served to improve the surgical results of ocular surface reconstruction and decrease the use of 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 mucosal epithelial transplant | Experimental | Procedure: Cultivated mucosal epithelial transplantationCultivated mucosal epithelial transplantaion to limbal deficiency patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology
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 mucosal epithelial transplantationcultivated autologous mucosal epithelium, then transplant to limbal stem cell deficiency patients. | Procedure or surgery | Cultivated mucosal epithelial transplant |
Primary outcome
Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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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.
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 mucosal epithelial transplantation in people with Ocular Surface Disease, 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: status not confirmed, as of the sponsor's last update on 16 Sep 2013. 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?
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?
Ocular surface clinical and pathological status(signs of limbal deficiency and immunopathological markers)after the surgery (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 16 Sep 2013.