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Tissue Engineering
ACCE Transplant for Limbal Stem Cell Deficiency (CECA Trial)
N/A
Recruiting
Led By Richard Bazin, MD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
CECA Trial 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.Check my eligibility
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.See study design
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.
CECA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anatomic assessment
Secondary outcome measures
Best corrected visual acuity
Level of pain
Quality of life measurements
CECA 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
167 Previous Clinical Trials
107,103 Total Patients Enrolled
Richard Bazin, MDPrincipal InvestigatorCHU de Quebec
Ralph Kyrillos, MD FRCS (C)Principal InvestigatorCHU de Quebec
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I have limbal stem cell deficiency in one or both eyes but enough healthy tissue for a safe biopsy.The donor eye is not healthy enough for a safe small biopsy.You are currently breastfeeding a child.I am legally not able to make my own decisions.You are pregnant.I am an adult.My gender does not affect my eligibility.
Research Study Groups:
This trial has the following groups:- Group 1: ACCE (Autologous Cultured Corneal Epithlium) graft for the treatment of corneal lesions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research subjects are participating in this trial at most?
"The clinical trial is currently ongoing and recruiting participants, according to the information available on clinicaltrials.gov. This study was first posted on December 1st, 2012, and has been enrolling 54 patients across 3 locations since September 1st, 2021."
Answered by AI
Are people currently signing up to participate in this research?
"That is right, the clinicaltrials.gov website has information about this trial and that it is currently looking for participants. The trial was first posted on December 1st, 2012 and was updated September 1st, 2021. This study is recruiting 54 participants from 3 locations."
Answered by AI
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