Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency

• Sponsor: CHU de Quebec-Universite Laval (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01756365
• Collaborator: (none)
• Enrollment: 54
• Locations: 3
• Arm: 1
• Duration (Months): 180
• Patients Per Site: 18
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Limbal Stem Cell Deficiency	Procedure: surgical transplantation of CECA	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Dec 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CECA	Procedure: surgical transplantation of CECA

Outcome Measures

Primary Outcome Measures

1. Anatomic assessment [1 year]

   Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)

Secondary Outcome Measures

1. Best corrected visual acuity [1 year]

   Evaluation according to Snellen chart

2. level of pain [1 year]

   11 point numerical verbal scale

3. Quality of life [1 year]

   Health Utilities Index Mark 3

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network - Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
2	CIUSSS de l'Est de l'île de Montréal	Montréal	Quebec	Canada	H1T 2M4
3	Centre universitaire d'Ophtalmologie CHU de Québec - HSS	Québec		Canada	G1S 4L8

Sponsors and Collaborators

• CHU de Quebec-Universite Laval

Investigators

• Principal Investigator: Richard Bazin, MD, CHU de Quebec

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Richard Bazin, Clinical professor ophtalmology, director of the cornea service, CHU de Quebec-Universite Laval
• ClinicalTrials.gov Identifier: NCT01756365
• Other Study ID Numbers: LOEX 015
• First Posted: Dec 25, 2012
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

Study Results

No Results Posted as of Sep 5, 2021