Limbal Stem Cell DeficiencyCECANCT01756365
Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency
A study testing Surgical transplantation of ACCE in people with Limbal Stem Cell Deficiency, run by CHU de Quebec-Universite Laval at 4 sites in Canada.
Trial summary
The study " Autologous cultured corneal epithelium (CECA) for the treatment of corneal lesions associated with limbal stem cell deficiency" is the first clinical trial of this product manufactured at the LOEX laboratory. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Limbal Stem Cell Deficiency
- What is being tested?
- Surgical transplantation of ACCE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesCanada
- Study dates
- Dec 2012to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All genders
- Adults
- Minors
- LSCD in one or two eyes. A minimum of 1-3 mm2 of undamaged limbus is required for a biopsy to be taken without foreseeable adverse consequences for the donor eye
Who cannot join
- Donor eye not sufficiently healthy to allow for the harvesting of a 1-3 mm2 limbal biopsy without foreseeable consequences for the donor eye
- Pregnancy
- Breast-feeding
- Incapacitated person
- known allergy to aprotinine (Trasylol (R))
- Hypersensibility to bovine proteins
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
CIUSSS de l'Est de l'île de Montréal
Montreal, Quebec, H1T 2M4
Dorline Sokoundjou, MSc, 514-252-3400 ext. 7114, bfv2.hmr@ssss.gouv.qc.ca
Isabelle Brunette, MD
- Recruiting
McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine
Montreal, Quebec
Natallia Barysevich, CRC/nurse, 514-934-1934 ext. 22844, natallia.barysevich@muhc.mcgill.ca
Guillermo Rocha, MD, FRCSC
- Recruiting
Centre universitaire d'Ophtalmologie CHU de Québec - HSS
Québec, Quebec, G1S 4L8
Ralph Kyrillos, MD FRCS (C), 418-682-7573, ralph.kyrillos.1@ulaval.ca
Lucie Germain, PhD, 4185254444 ext. 61696, lucie.germain@fmed.ulaval.ca
- Recruiting
University Health Network - Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Jennifer Coleman, 416-340-4800 ext. 5389
Clara Chan, MD, FRCSC
About this study
Official title: Autologous Cultured Corneal Epithelium ( Culture d'épithélium cornéen Autologue CECA) for the Treatment of Unilateral Corneal Lesions Associated With Limbal Stem Cell Deficiency
The study " Autologous cultured corneal epithelium (CECA) for the treatment of corneal lesions associated with limbal stem cell deficiency" is the first clinical trial of this product manufactured at the LOEX laboratory. The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. The study is a phase I/phase II study with the goal to evaluate safety and efficacy of the CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.
The trial is open to all genders. The inclusion of 5 minors is planned.
- Conditions
- Limbal Stem Cell Deficiency
- Being tested
- Surgical transplantation of ACCE
- 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.
Surgical transplantation of ACCEProcedure or surgery
The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency.
| Study group | Role | What they receive |
|---|---|---|
| ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions | Experimental | Surgical transplantation of Autologous Cultured Corneal Epithelium Receives: Procedure: Surgical transplantation of ACCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic assessment
Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)
Measured: 1 year
Secondary outcomes (3)
Best corrected visual acuity
Evaluation according to Snellen chart
Measured: 1 year
Level of pain
11 point numerical verbal scale
Measured: 1 year
Quality of life measurements
Health Utilities Index Mark 3
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
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
- Model description
- The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. The study is a phase I / phase II study with the goal to evaluate safety and efficacy of the CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralph Kyrillos, CHU de Quebec-Universite Laval
- Investigators
- Ralph Kyrillos, MD FRCS (C), Principal investigator, CHU de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756365
- Sponsor's protocol ID
- LOEX 015
- Acronym
- CECA
- Status last verified
- Jul 2025
- First submitted
- 20 Dec 2012
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Cultured Corneal Epithelium ( Culture d'épithélium cornéen Autologue CECA) for the Treatment of Unilateral Corneal Lesions Associated With Limbal Stem Cell Deficiency
- ClinicalTrials.gov ID
- NCT01756365
- Acronym / sponsor ID
- CECA / LOEX 015
- Conditions
- Limbal Stem Cell Deficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Dec 2012 (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 study " Autologous cultured corneal epithelium (CECA) for the treatment of corneal lesions associated with limbal stem cell deficiency" is the first clinical trial of this product manufactured at the LOEX laboratory. The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. The study is a phase I/phase II study with the goal to evaluate safety and efficacy of the CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.
The trial is open to all genders. The inclusion of 5 minors is planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. The study is a phase I / phase II study with the goal to evaluate safety and efficacy of the CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.
| Arm | Type | Receives |
|---|---|---|
| ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions | Experimental | Procedure: Surgical transplantation of ACCESurgical transplantation of Autologous Cultured Corneal Epithelium |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All genders
- Adults
- Minors
- LSCD in one or two eyes. A minimum of 1-3 mm2 of undamaged limbus is required for a biopsy to be taken without foreseeable adverse consequences for the donor eye
Key exclusion criteria (6 listed)
- Donor eye not sufficiently healthy to allow for the harvesting of a 1-3 mm2 limbal biopsy without foreseeable consequences for the donor eye
- Pregnancy
- Breast-feeding
- Incapacitated person
- known allergy to aprotinine (Trasylol (R))
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 |
|---|---|---|
| Surgical transplantation of ACCEThe culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. | Procedure or surgery | ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions |
Primary outcome
Anatomic assessment
Time frame: 1 year
Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)
3 secondary outcomes
Best corrected visual acuity
Time frame: 1 year
Level of pain
Time frame: 1 year
Quality of life measurements
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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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.
McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine
Montreal, Canada
Ralph Kyrillos, MD FRCS (C) principal investigator
CHU de Quebec
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical transplantation of ACCE in people with Limbal Stem Cell Deficiency, run by CHU de Quebec-Universite Laval at 4 sites in Canada.
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 6 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: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic assessment (time frame: 1 year). 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 Jul 2025.