Limbal Stem Cell DeficiencyNCT02568527
Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in LSCD Patients
A study testing PLGA scaffold in people with Limbal Stem Cell Deficiency, run by Virender S Sangwan, MBBS, MS at 1 site in India.
Trial summary
The purpose of this clinical study is to undertake a pilot safety and efficacy study of a synthetic biodegradable membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Limbal Stem Cell Deficiency
- What is being tested?
- PLGA scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2015to Jul 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants who are ≥18 years of age.
- Patients having a confirmed diagnosis of total LSCD as confirmed by any one or all of the following:
- In-growth of conjunctival epithelium over the cornea (conjunctivalization),
- 360o absence of limbal Palisades of Vogt,
- A fine stippled appearance on fluorescein staining,
- Persistent or recurrent corneal epithelial defects
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- Superficial vascularization,
- Dull and irregular corneal epithelium.
- Participants having unilateral limbal stem cell deficiency due to chemical injury
- No prior history of limbal transplantation
- No ongoing and other active ocular pathology
- No severe pathological and psychological conditions that might interfere with the patients participation in the study
- Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice.
Who cannot join
- Bilateral LSCD
- LSCD due to autoimmune disorders and partial LSCD
- Having other ongoing ocular pathologies and acute ocular inflammation
- Previous neoplastic/cancer disease
- Severe dry eyes confirmed by Schirmer's test
- Acute systemic infections
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- Prior history of limbal transplantation surgery or multiple surgeries in the limbal region
- Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patient's participation in the study or evaluation of the study results.
- Any uncontrolled, inter-current illness that in the opinion of the Investigator may interfere with study evaluation.
- Participants with uncontrolled diabetes will be excluded from the study
- History or evidence of cardiac disease: congestive heart failure; New York Heart Association (NYHA) class 2 or greater (see Appendix 6); active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization.
- Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential
- Reproductive age patients not practicing effective and adequate birth control measures
- Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study.
- Previous participation in this study
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluate Safety & Efficacy of PLGA Scaffold to Regenerate Limbal Epithelial Cells Using Autologous Limbal Grafts by SLET (Simple Limbal Epithelial Transplant) Procedure in Patients Having Total Unilateral LSCD
The purpose of this clinical study is to undertake a pilot safety and efficacy study of a synthetic biodegradable membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure
Read the detailed description
This study will involve the used of a synthetic biodegradable Poly Lactide-co-Glycolic Acid (PLGA) biodegradable, synthetic carrier membrane (PLGA) membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure.
This has the potential to simplify the current procedure and make it safer and accessible to more surgeons and eventually benefit more patients. The use of PLGA membrane, in place of hAM for limbal transplants, is a novel technique and has a lot of promise and potential, which will potentially benefit patients at large and significantly bring down costs for the limbal transplants while reducing the disease transmission risks of using human donor tissue.
- Conditions
- Limbal Stem Cell Deficiency
- Being tested
- PLGA scaffold
- Keywords
- LSCD, SLET, Donor Human Amniotic Membrane (hAM), PLGA
- Medical subject headings
- Limbal Stem Cell Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLGA scaffoldDevice
Also called Purasorb PDLG 5004
Poly-Lactic-co-Glycolic Acid (50:50) biodegradable, synthetic scaffold
| Study group | Role | What they receive |
|---|---|---|
| PLGA Scaffold | Experimental | Poly Lactide-co-Glycolic Acid (PLGA) 50:50 Receives: Device: PLGA scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Edema using Pachymetry
At Baseline and at Month 12
Measured: 12 months
Intraocular Pressure by Standard Applanation Tonometry
At Baseline and at Month 12
Measured: 12 months
Ocular Pain
Magnitude of pain will assessed as patient reported outcome using Visual Analogue Scale (VAS) in a scale of 1 to 10 (Wong-Baker Faces Pain Rating Scale)
Measured: 12 months
Schirmer's test (5 minute) without anesthesia
Measured: 12 months
Clinical Laboratory Adverse Events
Measured: 12 months
Vital Signs
Measured: 12 months
Secondary outcomes (2)
Regeneration of Stable Ocular Surface measured by Slit lamp Biomicroscopy Examination and Slit Lamp Photography
Measured: 12 months
Best Corrected Visual Acuity by Snellen Chart
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 posted6 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virender S Sangwan, MBBS, MS
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, University of Sheffield
- Responsible party
- Sponsor-investigator, Virender S Sangwan, MBBS, MS, L.V. Prasad Eye Institute
- Investigators
- Virender S Sangwan, MBBS MS, Principal investigator, LV Prasad Eye InstituteSayan Basu, MBBS MS, Study director, LV Prasad Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568527
- Sponsor's protocol ID
- LVPEI-2012-11
- Status last verified
- Apr 2016
- First submitted
- 27 Aug 2015
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Safety & Efficacy of PLGA Scaffold to Regenerate Limbal Epithelial Cells Using Autologous Limbal Grafts by SLET (Simple Limbal Epithelial Transplant) Procedure in Patients Having Total Unilateral LSCD
- ClinicalTrials.gov ID
- NCT02568527
- Acronym / sponsor ID
- LVPEI-2012-11
- Conditions
- Limbal Stem Cell Deficiency
- Keywords
- LSCD, SLET, Donor Human Amniotic Membrane (hAM), PLGA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Virender S Sangwan, MBBS, MSUniversity, hospital or other
- Collaborators
- Wellcome Trust, University of Sheffield
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 6 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.
The purpose of this clinical study is to undertake a pilot safety and efficacy study of a synthetic biodegradable membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure
Detailed description
This study will involve the used of a synthetic biodegradable Poly Lactide-co-Glycolic Acid (PLGA) biodegradable, synthetic carrier membrane (PLGA) membrane as a substitute for using donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly excised limbal tissue in theatre as a one stage procedure.
This has the potential to simplify the current procedure and make it safer and accessible to more surgeons and eventually benefit more patients. The use of PLGA membrane, in place of hAM for limbal transplants, is a novel technique and has a lot of promise and potential, which will potentially benefit patients at large and significantly bring down costs for the limbal transplants while reducing the disease transmission risks of using human donor tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLGA Scaffold | Experimental | Device: PLGA scaffoldPoly Lactide-co-Glycolic Acid (PLGA) 50:50 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female participants who are ≥18 years of age.
- Patients having a confirmed diagnosis of total LSCD as confirmed by any one or all of the following:
- Participants having unilateral limbal stem cell deficiency due to chemical injury
- No prior history of limbal transplantation
- No ongoing and other active ocular pathology
Key exclusion criteria (16 listed)
- Bilateral LSCD
- LSCD due to autoimmune disorders and partial LSCD
- Having other ongoing ocular pathologies and acute ocular inflammation
- Previous neoplastic/cancer disease
- Severe dry eyes confirmed by Schirmer's test
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 |
|---|---|---|
| PLGA scaffoldAlso: Purasorb PDLG 5004Poly-Lactic-co-Glycolic Acid (50:50) biodegradable, synthetic scaffold | Device | PLGA Scaffold |
Primary outcome
Corneal Edema using Pachymetry
Time frame: 12 months
At Baseline and at Month 12
Intraocular Pressure by Standard Applanation Tonometry
Time frame: 12 months
At Baseline and at Month 12
Ocular Pain
Time frame: 12 months
Magnitude of pain will assessed as patient reported outcome using Visual Analogue Scale (VAS) in a scale of 1 to 10 (Wong-Baker Faces Pain Rating Scale)
Schirmer's test (5 minute) without anesthesia
Time frame: 12 months
Clinical Laboratory Adverse Events
Time frame: 12 months
Vital Signs
Time frame: 12 months
2 secondary outcomes
Regeneration of Stable Ocular Surface measured by Slit lamp Biomicroscopy Examination and Slit Lamp Photography
Time frame: 12 months
Best Corrected Visual Acuity by Snellen Chart
Time frame: 12 months
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 9 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Virender S Sangwan, MBBS MS principal investigator
LV Prasad Eye Institute
Sayan Basu, MBBS MS study director
LV Prasad Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLGA scaffold in people with Limbal Stem Cell Deficiency, run by Virender S Sangwan, MBBS, MS at 1 site in India.
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 13 inclusion and 16 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 9 Aug 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 India. 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 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?
Corneal Edema using Pachymetry (time frame: 12 months). The study lists 6 primary outcomes in all. 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 9 Aug 2018.