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Stem Cell Therapy

Cultivation of Limbal epithelial cells into a graft for Limbal Stem Cell Deficiency (CALEC Trial)

Q: Are people who are 20 years or older eligible to participate in this research?

<p>Eligibility criteria for this study include being over 18 and under 89 years old.</p>

Phase 1 & 2

Waitlist Available

Led By Ula Jurkunas, MD

Research Sponsored by Massachusetts Eye and Ear Infirmary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

CALEC Trial Summary

This trial is testing whether a cultivated autologous limbal epithelial cell transplant is safe and effective in treating limbal stem cell deficiency.

Eligible Conditions

Limbal Stem Cell Deficiency

CALEC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility - avoiding culture contamination

Feasibility - obtaining cell growth and maintaining cell viability

Safety - The occurrence adverse events and their relationship to the study intervention

+3 more

Secondary outcome measures

Efficacy - Decrease in neovascularization

Efficacy - Improvement in corneal surface Integrity

Efficacy- Decrease in subject symptoms

CALEC Trial Design

1Treatment groups

Experimental Treatment

Group I: Cultivated Autologous Limbal Epithelial Cell (CALEC) graftExperimental Treatment3 Interventions

Participants will have a corneal biopsy in their non-diseased eye, which will provide cells for the creation of the CALEC graft. The CALEC will be made at the Good Manufacturing Practice (GMP) Laboratory, Dana Farber Cancer Institute and transported to Mass. Eye and Ear Infirmary for application to the participant's diseased eye during their standard corneal reconstruction procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cultivation of Limbal epithelial cells into a graft

2016

Completed Phase 2

~20

Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft

2016

Completed Phase 2

~20

CALEC Transplant

2016

Completed Phase 2

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor

106 Previous Clinical Trials

12,935 Total Patients Enrolled

Dana-Farber Cancer InstituteOTHER

1,078 Previous Clinical Trials

340,858 Total Patients Enrolled

Ula Jurkunas, MD4.823 ReviewsPrincipal Investigator - Massachusetts Eye and Ear Infirmary

Massachusetts Eye and Ear Infirmary

1 Previous Clinical Trials

45 Total Patients Enrolled

5Patient Review

This doctor is excellent at PRK surgery and follow-up care. They are very thorough and take the time to think things through.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being sought for this research?

"Although this clinical trial is not recruiting patients at the moment, that may change in the future. The study was originally posted on 8/1/2016 and was updated as recently as 3/21/2022 according to clinicaltrials.gov. There are 6 other trials open for recruitment presently."

Answered by AI

For which patients is this trial appropriate?

"This study is recruiting 17 patients with limbal stem cell deficiency (LSCD). The following inclusion criteria must be met: Ability of a subject or guardian/legal representative to provide written informed consent and to comply with study assessments for the full duration of the study., Male or female participants age 18 to <90 years old at time of enrollment, Patients with unilateral limbal stem cell deficiency (LSCD) as determined by conjunctivalization of the cornea defined by fibrovascular pannus more than 2 mm from the limbus for greater than or equal to 6 clock hours., Lack of limbal palisades"

Answered by AI