Limbal Stem Cell DeficiencyPhase 1/2NCT00736307
Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients
A Phase 1/2 study testing Cultured limbal stem cells Transplantation in people with Limbal Stem Cell Deficiency, run by Royan Institute at 2 sites in Iran.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Limbal Stem Cell Deficiency
- What is being tested?
- Cultured limbal stem cells Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesIran
- Study dates
- Oct 2007to Oct 2009
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with unilateral limbal stem cell insufficiency and totally corneal vascularization
- Presence of Goblet cells on the cornea
- Minimum tear was about 5 mm
- Minimum duration of deficiency was 3 years
- Vision was Light Perception
Who cannot join
- Systemic disease affecting both eyes such as Stevens-Johnson syndrome
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Royan Institute
Tehran, Tehran Province, 1665659911
Labbafinejad Ophthalmic Research Center
Tehran, Tehran Province, 16666
About this study
Official title: Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD)
The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency.
Read the detailed description
Ocular surface is composed of corneal and conjunctival epithelial cells. Normal cornea is essential for normal vision. Defects in renewal and repair of ocular surface as a result of limbal stem cell deficiency are now known to cause varying ocular surface morbidity including persistent photophobia, repeated and persistent surface breakdown and overt conjunctivalisation of the cornea. Restoring ocular health in these eyes has traditionally been frustrating. Ex vivo cultured limbal epithelial stem cells have been used successfully to treat limbal stem cell deficiency. Ex-vivo limbal stem cell allograft transplantation is achieved by harvesting limbal corneal tissue from donor eyes (either matched living relatives or cadaveric donors). The donor stem cells are obtained by excising a small area of the conjunctiva at the limbus and are a minor procedure. The tissue so obtained is then grown in tissue culture and once the cells have multiplied sufficiently, small sheets are transplanted on to the affected eye(s), backed with an amniotic membrane. The surgery is undertaken under either local or general anesthesia.
- Conditions
- Limbal Stem Cell Deficiency
- Being tested
- Cultured limbal stem cells Transplantation
- Keywords
- limbal stem cell deficiency
- 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.
Cultured limbal stem cells TransplantationProcedure or surgery
Also called Transplantation
Transplantation of cultivated limbal epithelium on amniotic membrane
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cultured limbal stem cells Transplantation Receives: Procedure: Cultured limbal stem cells Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Snellen visual acuity
Measured: 6 months
corneal epithelial integrity and stability
Measured: 6 months
Secondary outcomes (2)
Impression cytology
Measured: 12 months
Extent of retarding recurrent neovascularisation
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 posted15 Aug 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2009
- Study completionOct 2009
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 1/2
- 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
- Collaborators
- Small Business Developing Center, Labafi Nejad Eye Research Center
- Investigators
- Hamid Gorabi, PhD, Study chair, Royan institute, Tehran, IranMohammadali Javadi, MD, Study chair, Labbafinejad Ophthalmic Research Center, Tehran, IranHossein Baharvand, PhD, Principal investigator, Royan institute, Tehran, IranAlireza Baradaran, MD, Principal investigator, Labbafinejad, Ophthalmic Research Center, Tehran, IranMarzieh Ebrahimi, PhD, Study director, Royan Institute, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736307
- Sponsor's protocol ID
- ROYAN-EYE-001
- Status last verified
- Apr 2010
- First submitted
- 14 Aug 2008
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD)
- ClinicalTrials.gov ID
- NCT00736307
- Acronym / sponsor ID
- ROYAN-EYE-001
- Conditions
- Limbal Stem Cell Deficiency
- Keywords
- limbal stem cell deficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Collaborators
- Small Business Developing Center, Labafi Nejad Eye Research Center
- Study start
- Oct 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 15 Aug 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 evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency.
Detailed description
Ocular surface is composed of corneal and conjunctival epithelial cells. Normal cornea is essential for normal vision. Defects in renewal and repair of ocular surface as a result of limbal stem cell deficiency are now known to cause varying ocular surface morbidity including persistent photophobia, repeated and persistent surface breakdown and overt conjunctivalisation of the cornea. Restoring ocular health in these eyes has traditionally been frustrating. Ex vivo cultured limbal epithelial stem cells have been used successfully to treat limbal stem cell deficiency. Ex-vivo limbal stem cell allograft transplantation is achieved by harvesting limbal corneal tissue from donor eyes (either matched living relatives or cadaveric donors). The donor stem cells are obtained by excising a small area of the conjunctiva at the limbus and are a minor procedure. The tissue so obtained is then grown in tissue culture and once the cells have multiplied sufficiently, small sheets are transplanted on to the affected eye(s), backed with an amniotic membrane. The surgery is undertaken under either local or general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Cultured limbal stem cells TransplantationCultured limbal stem cells Transplantation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with unilateral limbal stem cell insufficiency and totally corneal vascularization
- Presence of Goblet cells on the cornea
- Minimum tear was about 5 mm
- Minimum duration of deficiency was 3 years
- Vision was Light Perception
Key exclusion criteria (1 listed)
- Systemic disease affecting both eyes such as Stevens-Johnson syndrome
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 |
|---|---|---|
| Cultured limbal stem cells TransplantationAlso: TransplantationTransplantation of cultivated limbal epithelium on amniotic membrane | Procedure or surgery | 1 |
Primary outcome
Snellen visual acuity
Time frame: 6 months
corneal epithelial integrity and stability
Time frame: 6 months
2 secondary outcomes
Impression cytology
Time frame: 12 months
Extent of retarding recurrent neovascularisation
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 15 Jul 2011.
- Related InfoLink provided by the sponsor.
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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.
Hamid Gorabi, PhD study chair
Royan institute, Tehran, Iran
Mohammadali Javadi, MD study chair
Labbafinejad Ophthalmic Research Center, Tehran, Iran
Hossein Baharvand, PhD principal investigator
Royan institute, Tehran, Iran
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cultured limbal stem cells Transplantation in people with Limbal Stem Cell Deficiency, run by Royan Institute at 2 sites in Iran.
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 5 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: finished, as of the sponsor's last update on 15 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Snellen visual acuity (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?
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 15 Jul 2011.