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Tissue Engineering

ACCE Transplant for Limbal Stem Cell Deficiency (CECA Trial)

N/A
Recruiting
Led By Ralph Kyrillos, MD FRCS (C)
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Donor eye not sufficiently healthy to allow for the harvesting of a 1-3 mm2 limbal biopsy without foreseeable consequences for the donor eye
Incapacitated person
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is the first clinical study of a product that may help treat corneal lesions associated with limbal stem cell deficiency.

Who is the study for?
This trial is for individuals with Limbal Stem Cell Deficiency (LSCD) in one or both eyes. Participants can be adults of any gender, including minors, but must have a small area of healthy limbus tissue for biopsy. Those who are pregnant, breastfeeding, unable to consent, or allergic to certain medications like Trasylol(R) cannot join.
What is being tested?
The study tests the safety and effectiveness of transplanting Autologous Cultured Corneal Epithelium (CECA), grown in a lab from the patient's own cells, as a treatment for LSCD. This Phase I/II trial aims to repair corneal lesions by replacing damaged tissue.
What are the potential side effects?
Potential side effects may include complications at the biopsy site on the donor eye or adverse reactions related to surgical transplantation such as infection, inflammation, or rejection of the transplanted tissue.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
The donor eye is not healthy enough for a safe small biopsy.
Select...
I am legally not able to make my own decisions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anatomic assessment
Secondary study objectives
Best corrected visual acuity
Level of pain
Quality of life measurements

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesionsExperimental Treatment1 Intervention
Surgical transplantation of Autologous Cultured Corneal Epithelium

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
172 Previous Clinical Trials
109,621 Total Patients Enrolled
Ralph Kyrillos, MD FRCS (C)Principal InvestigatorCHU de Quebec
Richard Bazin, MDPrincipal InvestigatorCHU de Quebec

Media Library

Autologous Cultured Corneal Epithelium (CECA) (Tissue Engineering) Clinical Trial Eligibility Overview. Trial Name: NCT01756365 — N/A
Limbal Stem Cell Deficiency Research Study Groups: ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions
Limbal Stem Cell Deficiency Clinical Trial 2023: Autologous Cultured Corneal Epithelium (CECA) Highlights & Side Effects. Trial Name: NCT01756365 — N/A
Autologous Cultured Corneal Epithelium (CECA) (Tissue Engineering) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01756365 — N/A
~4 spots leftby Dec 2025
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