SymblepharonPhase 1NCT00799526
Transplant of Epithelium Conjunctival Human Autologous Cultivated ex Vivo in Amniotic Membrane for the Treatment of Symblepharon
A Phase 1 study testing Autologous Ex Vivo Conjunctival for Symblepharon Transplantation and Ex Vivo Conjunctival for Symblepharon Transplantation in people with Symblepharon, run by Federal University of São Paulo.
Trial summary
The purpose of this study is to investigate the safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface in patients with symblepharon. Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Symblepharon
- What is being tested?
- Autologous Ex Vivo Conjunctival for Symblepharon Transplantation and Ex Vivo Conjunctival for Symblepharon Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Nov 2010
- 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 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with ocular surface disorders, e.g. symblepharon
- Indications for surgery will be the presence of ocular surface symptoms in the affected eye, loss of visual acuity from visual axis obscuration or irregular astigmatism, or cosmesis.
- Only one eye of a patient will be eligible for study entry.
- Patients who are adult males and females who are aged 16 or older, and are considered mentally sound
- Patients who are willing to undergo long-term follow-up, as outlined in this protocol
- Patients who have signed an informed consent form that has been approved by the SNEC Ethics Committee.
Who cannot join
- Patients less than 16 years of age
- Patients who are incapable, either by law or of mental state, of giving consent in their own right
- Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol
- Patients who are pregnant or breastfeeding
- Patients with a history of drug allergy
- Patients who have received an investigational drug within 28 days preceding surgery
- Patients with intraocular pressure over 21 mmHg or history of ocular hypertension or glaucoma
- Patients who are documented to be steroid responders
About this study
The purpose of this study is to investigate the safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface in patients with symblepharon.
Read the detailed description
10 patients will be included from 16 to 90 years with presence of symblepharon, what have been already subjected to proceedings of reconstruction of the ocular surface without success and to present conjunctival healthy. In the place of biopsy and after the surgery of the patient one will be applied ointment with antibiotic and corticoid to minimize the inflammatory effects. The fragments will be transported even it laboratory of Molecular Biology of the advanced Centre of Ocular Surface where it will be prosecuted by means of technique sterile under laminating flow. The conjunctival epithelias cells will be put on the amniotic membrane compartments of the plate of culture where the appropriate ways will be added. After 2 weeks the membranes colonized with epithelium conjunctival they will be subjected to the coloration and the cloth will be used for the surgery of reconstruction of the ocular surface. It will be carried out first us an evaluation ophthalmologic complete weekly, 2 months and then fortnightly up to the sixth month post-operative.
- Conditions
- Symblepharon
- Being tested
- Autologous Ex Vivo Conjunctival for Symblepharon Transplantation, Ex Vivo Conjunctival for Symblepharon Transplantation
- Keywords
- Ex Vivo Conjunctival Epithelial Cell, Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Ex Vivo Conjunctival for Symblepharon TransplantationProcedure or surgery
Safety and efficacy of conjunctival ex vivo for reconstruction of the ocular surface.
Ex Vivo Conjunctival for Symblepharon TransplantationProcedure or surgery
The safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface with symblepharon.
| Study group | Role | What they receive |
|---|---|---|
| Ex Vivo Transplantation | Experimental | Autologous Ex Vivo Conjunctival Epithelial Cell Expansion for Symblepharon Transplantation Receives: Procedure: Autologous Ex Vivo Conjunctival for Symblepharon Transplantation; Procedure: Ex Vivo Conjunctival for Symblepharon Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconstruction of Ocular surface in patients with symblepharon
Measured: 6 months
Secondary outcomes (1)
Re - reconstruction of Ocular surface in patients with symblepharon
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2008
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SymblepharonStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799526
- Sponsor's protocol ID
- 1075/08
- Status last verified
- Nov 2008
- First submitted
- 28 Nov 2008
- Last updated
- 1 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplant of Epithelium Conjunctival Human Autologous Cultivated ex Vivo in Amniotic Membrane for the Treatment of Symblepharon
- ClinicalTrials.gov ID
- NCT00799526
- Acronym / sponsor ID
- 1075/08
- Conditions
- Symblepharon
- Keywords
- Ex Vivo Conjunctival Epithelial Cell, Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2010 (estimated)
- First posted
- 1 Dec 2008 (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 investigate the safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface in patients with symblepharon.
Detailed description
10 patients will be included from 16 to 90 years with presence of symblepharon, what have been already subjected to proceedings of reconstruction of the ocular surface without success and to present conjunctival healthy. In the place of biopsy and after the surgery of the patient one will be applied ointment with antibiotic and corticoid to minimize the inflammatory effects. The fragments will be transported even it laboratory of Molecular Biology of the advanced Centre of Ocular Surface where it will be prosecuted by means of technique sterile under laminating flow. The conjunctival epithelias cells will be put on the amniotic membrane compartments of the plate of culture where the appropriate ways will be added. After 2 weeks the membranes colonized with epithelium conjunctival they will be subjected to the coloration and the cloth will be used for the surgery of reconstruction of the ocular surface. It will be carried out first us an evaluation ophthalmologic complete weekly, 2 months and then fortnightly up to the sixth month post-operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ex Vivo Transplantation | Experimental | Procedure: Autologous Ex Vivo Conjunctival for Symblepharon Transplantation, Procedure: Ex Vivo Conjunctival for Symblepharon TransplantationAutologous Ex Vivo Conjunctival Epithelial Cell Expansion for Symblepharon Transplantation |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with ocular surface disorders, e.g. symblepharon
- Indications for surgery will be the presence of ocular surface symptoms in the affected eye, loss of visual acuity from visual axis obscuration or irregular astigmatism, or cosmesis.
- Only one eye of a patient will be eligible for study entry.
- Patients who are adult males and females who are aged 16 or older, and are considered mentally sound
- Patients who are willing to undergo long-term follow-up, as outlined in this protocol
Key exclusion criteria (8 listed)
- Patients less than 16 years of age
- Patients who are incapable, either by law or of mental state, of giving consent in their own right
- Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol
- Patients who are pregnant or breastfeeding
- Patients with a history of drug allergy
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 |
|---|---|---|
| Autologous Ex Vivo Conjunctival for Symblepharon TransplantationSafety and efficacy of conjunctival ex vivo for reconstruction of the ocular surface. | Procedure or surgery | Ex Vivo Transplantation |
| Ex Vivo Conjunctival for Symblepharon TransplantationThe safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface with symblepharon. | Procedure or surgery | Ex Vivo Transplantation |
Primary outcome
Reconstruction of Ocular surface in patients with symblepharon
Time frame: 6 months
1 secondary outcome
Re - reconstruction of Ocular surface in patients with symblepharon
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2008.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Ex Vivo Conjunctival for Symblepharon Transplantation and Ex Vivo Conjunctival for Symblepharon Transplantation in people with Symblepharon, run by Federal University of São Paulo.
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 6 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 1 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Reconstruction of Ocular surface in patients with symblepharon (time frame: 6 months). 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 1 Dec 2008.