Unilateral Limbic InsufficiencyPhase 2MeRSO09NCT01470573
Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Cells of Sclerocorneal Limbus Amplified ex Vivo
A Phase 2 study testing biological replacement corneal surface in people with Unilateral Limbic Insufficiency, run by Fundacion Clinic per a la Recerca Biomédica at 3 sites in Spain.
Trial summary
Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using cell culture technics that could permit the biological replacement of damaged ocular surface. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unilateral Limbic Insufficiency
- What is being tested?
- biological replacement corneal surface
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesSpain
- Study dates
- Nov 2011to Dec 2012
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- one-eyed
- serious disorders in palpebral dynamics
- bilateral limbic insufficiency, immunological, systemic or local illness like toxical epidermic necrosis or pemphigoid
- breastfeeding or pregnancy
- positive serology of HIV, VLTH, HVC, HVB, CMV, Trypanosoma Cruzi or Treponema Pallidum
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Instituto Universitario Barraquer
Barcelona, Barcelona, 08021
Instituto de Microcirugía Ocular
Barcelona, Barcelona, 08035
Hospital Clinic of Barcelona
Barcelona, Barcelona, 08036
About this study
Official title: Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Autologous Cells of Sclerocorneal Limbus Amplified ex Vivo
Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using cell culture technics that could permit the biological replacement of damaged ocular surface.
- Conditions
- Unilateral Limbic Insufficiency
- Being tested
- biological replacement corneal surface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological replacement corneal surfaceProcedure or surgery
the expanded tissue will be applied to patient to replace the damaged ocular surface
| Study group | Role | What they receive |
|---|---|---|
| Progenitor Autologous Cells | Experimental | Progenitor Autologous Cells of Sclerocorneal Limbus Amplified ex Vivo Receives: Procedure: biological replacement corneal surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
visual acuity improvement
Measured: 6 months
Secondary outcomes (6)
Improvement in appearance of ocular surface
presence of corneal epithelium de novo
Measured: 6 months
lack of scar tissue in ocular surface
Measured: 6 months
decrease of preexisting corneal vascularization
Measured: 6 months
Improvement of corneal transparency
Measured: 6 months
absence or decrease of corneal conjunctivalization
the amount of caliciform cells using impression cytology will be compare between screening and 6 months visit
Measured: 6 months
adverse events
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 posted11 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Limbic InsufficiencyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Varea, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Ricardo P Casaroli Marano, MD PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470573
- Sponsor's protocol ID
- MeRSO09
- Acronym
- MeRSO09
- Status last verified
- Dec 2012
- First submitted
- 9 Nov 2011
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Autologous Cells of Sclerocorneal Limbus Amplified ex Vivo
- ClinicalTrials.gov ID
- NCT01470573
- Acronym / sponsor ID
- MeRSO09 / MeRSO09
- Conditions
- Unilateral Limbic Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Nov 2011 (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.
Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using cell culture technics that could permit the biological replacement of damaged ocular surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Progenitor Autologous Cells | Experimental | Procedure: biological replacement corneal surfaceProgenitor Autologous Cells of Sclerocorneal Limbus Amplified ex Vivo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- one-eyed
- serious disorders in palpebral dynamics
- bilateral limbic insufficiency, immunological, systemic or local illness like toxical epidermic necrosis or pemphigoid
- breastfeeding or pregnancy
- positive serology of HIV, VLTH, HVC, HVB, CMV, Trypanosoma Cruzi or Treponema Pallidum
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 |
|---|---|---|
| biological replacement corneal surfacethe expanded tissue will be applied to patient to replace the damaged ocular surface | Procedure or surgery | Progenitor Autologous Cells |
Primary outcome
Visual Acuity
Time frame: 6 months
visual acuity improvement
6 secondary outcomes
Improvement in appearance of ocular surface
Time frame: 6 months
lack of scar tissue in ocular surface
Time frame: 6 months
decrease of preexisting corneal vascularization
Time frame: 6 months
Improvement of corneal transparency
Time frame: 6 months
absence or decrease of corneal conjunctivalization
Time frame: 6 months
adverse events
Time frame: 6 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 10 Dec 2012.
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.
Ricardo P Casaroli Marano, MD PhD principal investigator
Hospital Clinic of Barcelona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing biological replacement corneal surface in people with Unilateral Limbic Insufficiency, run by Fundacion Clinic per a la Recerca Biomédica at 3 sites in Spain.
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 0 inclusion and 5 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 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 phase mean?
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?
Visual Acuity (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 10 Dec 2012.