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

Limbal Stem Cell Deficiency Clinical Trial

— CECA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01756365
• Other study ID #: LOEX 015
• Status: Recruiting
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2027

Study information

• Verified date: January 2023
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Limbal Stem Cell Deficiency

Intervention

Procedure:
• Surgical transplantation of ACCE
The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency.

Locations

Country	Name	City	State
Canada	CIUSSS de l'Est de l'île de Montréal	Montréal	Quebec
Canada	Centre universitaire d'Ophtalmologie CHU de Québec - HSS	Québec
Canada	University Health Network - Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomic assessment	Global severity score (Epithelial deficit, corneal opacity, peripheral and central vascularization, integrity of the ocular surface)	1 year
Secondary	Best corrected visual acuity	Evaluation according to Snellen chart	1 year
Secondary	Level of pain	11 point numerical verbal scale	1 year
Secondary	Quality of life measurements	Health Utilities Index Mark 3	1 year