Recruiting

CECA

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT01756365

Conditions

Limbal Stem Cell Deficiency

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

Surgical transplantation of ACCE

Study Details

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.

Conditions

Limbal Stem Cell Deficiency

Study ID

NCT01756365

Start date

Dec, 2012

Status verified date

Jul, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

54 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions

Surgical transplantation of Autologous Cultured Corneal Epithelium

Interventions

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.

Primary outcome measure

  • Anatomic assessment [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

University Health Network - Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Jennifer Coleman

416-340-4800

Principal Investigator:

Clara Chan, MD, FRCSC

CIUSSS de l'Est de l'île de Montréal

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Dorline Sokoundjou, MSc

514-252-3400bfv2.hmr@ssss.gouv.qc.ca

Principal Investigator:

Isabelle Brunette, MD

McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine

Recruiting

Montreal, Quebec, Canada

Contacts

Natallia Barysevich, CRC/nurse

514-934-1934natallia.barysevich@muhc.mcgill.ca

Principal Investigator:

Guillermo Rocha, MD, FRCSC

Centre universitaire d'Ophtalmologie CHU de Québec - HSS

Recruiting

Québec, Quebec, Canada, G1S 4L8

Contacts

Ralph Kyrillos, MD FRCS (C)

418-682-7573ralph.kyrillos.1@ulaval.ca

Lucie Germain, PhD

4185254444lucie.germain@fmed.ulaval.ca

Principal Investigator:

Ralph Kyrillos, MD FRCS (C)

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Jul 10, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2025-07-10.