Limbal Stem Cell DeficiencyNCT02579993
ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation
A study testing Pannus and conjunctival dissection and Human cultivated limbal stem cell transplantation in people with Limbal Stem Cell Deficiency, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Limbal Stem Cell Deficiency
- What is being tested?
- Pannus and conjunctival dissection and Human cultivated limbal stem cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2015to Mar 2018
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Bilateral limbal stem cell deficiency of any etiology.
- Corneal impression cytology positive for goblet cells.
- Ocular ultrasound results within normal parameters.
- Agree to participate in the study and sign the informed consent.
Who cannot join
- 1. Active immunological diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation Expanded in Vitro on Amniotic Membrane in Patients With Limbal Stem Cell Deficiency.
In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed.
Read the detailed description
There are several diseases that cause the cornea to lose its clarity and directly affects the vision of the individual, therefore, the use of limbal stem cells has been having increasing acceptance in the field of medical therapy. An open clinical study is running with patients with limbal stem cell deficiency, performing a limbal stem cell transplantation expanded in vitro on amniotic membrane and the value of ABCB5 as a prognostic factor in the survival of transplant will be determined. The corneal surface status will be the primary endpoint.
- Conditions
- Limbal Stem Cell Deficiency
- Being tested
- Pannus and conjunctival dissection, Human cultivated limbal stem cell transplantation
- Keywords
- Cornea, Limbal stem cell
- Medical subject headings
- Limbal Stem Cell Deficiency, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pannus and conjunctival dissectionProcedure or surgery
A complete conjunctival peritomy is performed and the fibrovascular pannus and conjunctiva invading the cornea is dissected from the cornea and limbus.
Human cultivated limbal stem cell transplantationProcedure or surgery
The amniotic membrane graft cultured with the human limbal stem cell transplantation is placed in the limbic and corneal surface and fixed with fibrin glue. The amniotic membrane is placed with the stroma in contact with the graft and it is sutured.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell Transplantation | Experimental | Cultivated Limbal Stem Cell Transplantation Receives: Procedure: Pannus and conjunctival dissection; Procedure: Human cultivated limbal stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective clinical evaluation
A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.
Measured: 6 months
Objective clinical evaluation
A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.
Measured: 12 months
Secondary outcomes (6)
Corneal cells morphology
Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology
Measured: 6 months
Corneal cells morphology
Evaluation of the presence of epithelial, conjunctival or mixed cells with in vivo confocal microscopy and impression cytology
Measured: 12 months
Quality of life questionnaire
Modified National Eye Institute Visual Function Questionnaire 25 questionnaire
Measured: 6 months
Quality of life questionnaire
Modified National Eye Institute Visual Function Questionnaire 25 questionnaire
Measured: 12 months
Visual acuity
Visual acuity in the Logarithm of the Minimum Angle of Resolution scale
Measured: 6 months
Visual acuity
Visual acuity in the Logarithm of the Minimum Angle of Resolution scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: Preliminar results not favorable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Limbal Stem Cell DeficiencyStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Sponsor
- Investigators
- Yonathan Garfias, MD, PhD, Study director, Instituto de Oftalmologia Conde de Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579993
- Sponsor's protocol ID
- CI-051-2014
- Status last verified
- Mar 2018
- First submitted
- 11 Oct 2015
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Serna-Ojeda JC, Garcia-Mejia M, Graue-Hernandez EO, Navas A, Garfias Y. Short-Term Results Analysis in the Allogenic Transplantation of Limbal Stem Cells Expanded on Amniotic Membrane in Patients with Bilateral Limbal Stem Cell Deficiency. J Ocul Pharmacol Ther. 2020 May;36(4):238-246. doi: 10.1089/jop.2019.0147. Epub 2020 Feb 20.
PubMed 32077779
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABCB5 as a Prognostic Marker in Survival of Cultivated Limbal Stem Cell Transplantation Expanded in Vitro on Amniotic Membrane in Patients With Limbal Stem Cell Deficiency.
- ClinicalTrials.gov ID
- NCT02579993
- Acronym / sponsor ID
- CI-051-2014
- Conditions
- Limbal Stem Cell Deficiency
- Keywords
- Cornea, Limbal stem cell
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminar results not favorable
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- Mar 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 20 Oct 2015 (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.
In this study the prognostic value of ABCB5 in survival of the limbal stem cell transplantation expanded in vitro on amniotic membrane for corneal surface reconstruction in patients with limbal stem cell deficiency will be analyzed.
Detailed description
There are several diseases that cause the cornea to lose its clarity and directly affects the vision of the individual, therefore, the use of limbal stem cells has been having increasing acceptance in the field of medical therapy. An open clinical study is running with patients with limbal stem cell deficiency, performing a limbal stem cell transplantation expanded in vitro on amniotic membrane and the value of ABCB5 as a prognostic factor in the survival of transplant will be determined. The corneal surface status will be the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell Transplantation | Experimental | Procedure: Pannus and conjunctival dissection, Procedure: Human cultivated limbal stem cell transplantationCultivated Limbal Stem Cell Transplantation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Bilateral limbal stem cell deficiency of any etiology.
- Corneal impression cytology positive for goblet cells.
- Ocular ultrasound results within normal parameters.
- Agree to participate in the study and sign the informed consent.
Key exclusion criteria (1 listed)
- 1. Active immunological diseases.
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 |
|---|---|---|
| Pannus and conjunctival dissectionA complete conjunctival peritomy is performed and the fibrovascular pannus and conjunctiva invading the cornea is dissected from the cornea and limbus. | Procedure or surgery | Stem Cell Transplantation |
| Human cultivated limbal stem cell transplantationThe amniotic membrane graft cultured with the human limbal stem cell transplantation is placed in the limbic and corneal surface and fixed with fibrin glue. The amniotic membrane is placed with the stroma in contact with the graft and it is sutured. | Procedure or surgery | Stem Cell Transplantation |
Primary outcome
Objective clinical evaluation
Time frame: 6 months
A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.
Objective clinical evaluation
Time frame: 12 months
A grading system from 0 to 4 using photographs taken with slit lamp, will be used to determine by two independent examiners the degree of corneal transparency and superficial vascularization.
6 secondary outcomes
Corneal cells morphology
Time frame: 6 months
Corneal cells morphology
Time frame: 12 months
Quality of life questionnaire
Time frame: 6 months
Quality of life questionnaire
Time frame: 12 months
Visual acuity
Time frame: 6 months
Visual acuity
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Preliminar results not favorable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Derived from this study: PubMed 32077779Serna-Ojeda JC, Garcia-Mejia M, Graue-Hernandez EO, Navas A, Garfias Y. Short-Term Results Analysis in the Allogenic Transplantation of Limbal Stem Cells Expanded on Amniotic Membrane in Patients with Bilateral Limbal Stem Cell Deficiency. J Ocul Pharmacol Ther. 2020 May;36(4):238-246. doi: 10.1089/jop.2019.0147. Epub 2020 Feb 20.
Related trials for Limbal Stem Cell Deficiency
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingPhase 1
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
Limbal Stem Cell Deficiency
RecruitingObservational study
Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
Limbal Stem Cell Deficiency
Not yet recruitingObservational study
Clinical Predictors of Visual Outcome in Patients Affected With Ocular Surface Diseases
Neurotrophic Keratopathy, Exposure Keratopathy
Active, not recruitingPhase 1
Stem Cell Therapy for Limbal Stem Cell Deficiency
Limbal Stem-cell Deficiency
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.
Yonathan Garfias, MD, PhD study director
Instituto de Oftalmologia Conde de Valenciana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pannus and conjunctival dissection and Human cultivated limbal stem cell transplantation in people with Limbal Stem Cell Deficiency, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 Mar 2018. 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 Mexico. 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?
The study was stopped early (reason given: Preliminar results not favorable). 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?
Objective clinical evaluation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02579993, which also lists 1 linked publication.
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 Mar 2018.