Limbal Stem Cell Deficiency (LSCD)Phase 1NCT02649621
The Improvement of Limbal Stem Cell Deficiency (LSCD) in Unilateral Stem Cell Damage by Amniotic Membrane Extract Eye Drop (AMEED)
A Phase 1 study testing Amniotic Membrane Extract Eye Drop (AMEED) in people with Limbal Stem Cell Deficiency (LSCD), run by Royan Institute.
Trial summary
Corneal epithelial cells and limbal stem cells (LSC) are located in the limbus basal epithelium that are necessary for repair of corneal. About patients with deficient or absence of this area has been proposed various treatments such as limbal stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Limbal Stem Cell Deficiency (LSCD)
- What is being tested?
- Amniotic Membrane Extract Eye Drop (AMEED)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Aug 2012
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with unilateral chemical burn (grade III to up); estimation of chemical burns amount and classification was according to Dua.
- Without Age limitation
Who cannot join
- Lack of timely referral of patients for examinations
- Simultaneous use of other drugs that cause impairment of the data
About this study
Official title: The Effect of in Vivo Cultured Limbal Stem Cells in the Treatment of Unilateral Corneal Stem Cell Damage
Corneal epithelial cells and limbal stem cells (LSC) are located in the limbus basal epithelium that are necessary for repair of corneal. About patients with deficient or absence of this area has been proposed various treatments such as limbal stem cell transplantation.
This study is a prospective clinical trial to compare the improvement of limbal stem cell deficiency (LSCD) in vivo by using of Amniotic Membrane Extract Eye Drop (AMEED).
Read the detailed description
The cornea is the eye anterior portion which its refractive power and transparent is essential for normal vision.
The damaged cornea surface can reduce vision and leads to blindness, ultimately. Corneal epithelial and some times, limbal stem cell (LSC) are involved in corneal injuries. Limbal stem cells (LSC) are necessary for repair and reconstruction of corneal that reduction of these cells occurs by various causes including congenital causes, eye inflammatory diseases and burns. For cornea stem cell damages or limbal stem cell deficiency (LSCD), cornea becomes conjunctivalization. LSCD may involve one eye (unilateral) or two eyes (bilateral).
Due to autologous transplantation problems in patients with unilateral LSCD and recent successes to resolve this problem, it seems that transplantation of cultured corneal stem cells on amniotic membrane is other way in treatment of unilateral LSCD. It is called ex vivo.
Amniotic membrane can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. It is well accepted that amniotic membrane transplantation (AMT) as a temporary patch normally dissolves within 2 weeks. Consequent reapplication of membrane is difficult for the patient. On the other hand, in ex vivo, corneal tissue from healthy eye must be transported to laboratory for cell culture on AM that is required equipment. There is, also, a risk of cell infection and transmission that is very important issue. However, in infected cells, re-biopsy of the healthy eye is required that is uncomfortable and difficult for the patient. Other studies have been reported that amniotic membrane extract (AME) has same characteristics and features.
We previously have reported an effective potential of AMEED in limbal stem cell proliferation in vitro and also rabbit corneal epithelium healing in vivo.
This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) on in vivo cultured limbal stem cells in the treatment of unilateral corneal stem cell damage.
- Conditions
- Limbal Stem Cell Deficiency (LSCD)
- Being tested
- Amniotic Membrane Extract Eye Drop (AMEED)
- Keywords
- Limbal Stem Cell Deficiency Amniotic Membrane Extract Eye Drop in vivo cultivation
- 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.
Amniotic Membrane Extract Eye Drop (AMEED)Biological
Use of use Amniotic Membrane Extract Eye Drop (AMEED) on in vivo cultured limbal stem cells in the treatment of unilateral corneal stem cell damage.
| Study group | Role | What they receive |
|---|---|---|
| Amniotic Membrane Extract Eye Drop recipient | Experimental | patients with limbal stem cell Deficiency who receive amniotic membrane transplantation and amniotic membrane extract eye drop as eye drop. Receives: Biological: Amniotic Membrane Extract Eye Drop (AMEED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limbal defect size
The measurement of limbal defect size by microscope 12 months after corneal surgery
Measured: 12 months
Corneal epithelial integrity
The measurement of Corneal epithelial integrity by microscope 12 months after corneal surgery
Measured: 12 months
Corneal epithelial stability
The measurement of Corneal epithelial stability by microscope 12 months after corneal surgery
Measured: 12 months
Secondary outcomes (3)
Vascularization
Evaluation the rate of corneal vascularization with microscope 12 months after surgery.
Measured: 12 months
Transparency
Evaluation the transparency with visual tests 12 months after surgery.
Measured: 12 months
Best spectacle corrected visual activity
Evaluation the best spectacle corrected visual activity with visual tests.
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 posted7 Jan 2016 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limbal Stem Cell Deficiency (LSCD)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteMarzieh Ebrahimi, PhD, Study director, Department of Regenerative Biomedicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.Alireza Baradaran, MD, Study director, Labafi Nejad Eye Research Center, Tehran, IranMitra Akbari, MD, Principal investigator, Labafi Nejad Eye Research Center, Tehran, IranNiloufar Shayan, MSc, Principal investigator, Department of Stem Cells and Developmental Biology at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.Maryam Momeni, MSc, Principal investigator, Department of Stem Cells and Developmental Biology at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649621
- Sponsor's protocol ID
- Royan-Eye-002
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2016
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of in Vivo Cultured Limbal Stem Cells in the Treatment of Unilateral Corneal Stem Cell Damage
- ClinicalTrials.gov ID
- NCT02649621
- Acronym / sponsor ID
- Royan-Eye-002
- Conditions
- Limbal Stem Cell Deficiency (LSCD)
- Keywords
- Limbal Stem Cell Deficiency Amniotic Membrane Extract Eye Drop in vivo cultivation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Jan 2016 (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.
Corneal epithelial cells and limbal stem cells (LSC) are located in the limbus basal epithelium that are necessary for repair of corneal. About patients with deficient or absence of this area has been proposed various treatments such as limbal stem cell transplantation.
This study is a prospective clinical trial to compare the improvement of limbal stem cell deficiency (LSCD) in vivo by using of Amniotic Membrane Extract Eye Drop (AMEED).
Detailed description
The cornea is the eye anterior portion which its refractive power and transparent is essential for normal vision.
The damaged cornea surface can reduce vision and leads to blindness, ultimately. Corneal epithelial and some times, limbal stem cell (LSC) are involved in corneal injuries. Limbal stem cells (LSC) are necessary for repair and reconstruction of corneal that reduction of these cells occurs by various causes including congenital causes, eye inflammatory diseases and burns. For cornea stem cell damages or limbal stem cell deficiency (LSCD), cornea becomes conjunctivalization. LSCD may involve one eye (unilateral) or two eyes (bilateral).
Due to autologous transplantation problems in patients with unilateral LSCD and recent successes to resolve this problem, it seems that transplantation of cultured corneal stem cells on amniotic membrane is other way in treatment of unilateral LSCD. It is called ex vivo.
Amniotic membrane can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. It is well accepted that amniotic membrane transplantation (AMT) as a temporary patch normally dissolves within 2 weeks. Consequent reapplication of membrane is difficult for the patient. On the other hand, in ex vivo, corneal tissue from healthy eye must be transported to laboratory for cell culture on AM that is required equipment. There is, also, a risk of cell infection and transmission that is very important issue. However, in infected cells, re-biopsy of the healthy eye is required that is uncomfortable and difficult for the patient. Other studies have been reported that amniotic membrane extract (AME) has same characteristics and features.
We previously have reported an effective potential of AMEED in limbal stem cell proliferation in vitro and also rabbit corneal epithelium healing in vivo.
This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) on in vivo cultured limbal stem cells in the treatment of unilateral corneal stem cell damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amniotic Membrane Extract Eye Drop recipient | Experimental | Biological: Amniotic Membrane Extract Eye Drop (AMEED)patients with limbal stem cell Deficiency who receive amniotic membrane transplantation and amniotic membrane extract eye drop as eye drop. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient with unilateral chemical burn (grade III to up); estimation of chemical burns amount and classification was according to Dua.
- Without Age limitation
Key exclusion criteria (2 listed)
- Lack of timely referral of patients for examinations
- Simultaneous use of other drugs that cause impairment of the data
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 |
|---|---|---|
| Amniotic Membrane Extract Eye Drop (AMEED)Use of use Amniotic Membrane Extract Eye Drop (AMEED) on in vivo cultured limbal stem cells in the treatment of unilateral corneal stem cell damage. | Biological | Amniotic Membrane Extract Eye Drop recipient |
Primary outcome
Limbal defect size
Time frame: 12 months
The measurement of limbal defect size by microscope 12 months after corneal surgery
Corneal epithelial integrity
Time frame: 12 months
The measurement of Corneal epithelial integrity by microscope 12 months after corneal surgery
Corneal epithelial stability
Time frame: 12 months
The measurement of Corneal epithelial stability by microscope 12 months after corneal surgery
3 secondary outcomes
Vascularization
Time frame: 12 months
Transparency
Time frame: 12 months
Best spectacle corrected visual activity
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 7 Jan 2016.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Limbal Stem Cell Deficiency (LSCD)
Not yet recruitingObservational study
Clinical Predictors of Visual Outcome in Patients Affected With Ocular Surface Diseases
Neurotrophic Keratopathy, Exposure Keratopathy
Not yet recruitingObservational study
Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD)
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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Marzieh Ebrahimi, PhD study director
Department of Regenerative Biomedicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Alireza Baradaran, MD study director
Labafi Nejad Eye Research Center, Tehran, Iran
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amniotic Membrane Extract Eye Drop (AMEED) in people with Limbal Stem Cell Deficiency (LSCD), run by Royan Institute.
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 2 inclusion and 2 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 Jan 2016. 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?
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?
Limbal defect size (time frame: 12 months). The study lists 3 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 7 Jan 2016.