Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft
(CALEC Trial)

Recruiting in Palo Alto (17 mi)

Overseen byUla Jurkunas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Massachusetts Eye and Ear Infirmary

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment where cells from a healthy part of a patient's eye are grown in a lab and then used to repair damage in the same patient's other eye. It targets patients with damage in one eye due to limbal stem cell deficiency. The goal is to see if this method is safe and effective. Limbal stem cell transplantation has been used to treat limbal stem cell deficiency by growing and transplanting cells from a healthy part of the eye.

Research Team

Ula Jurkunas, MD

Principal Investigator

Massachusetts Eye and Ear Infirmary

Eligibility Criteria

Inclusion Criteria

Male or female participants age 18 to <90 years old at time of enrollment

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

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

Exclusion Criteria

Participation in another simultaneous medical investigation or trial

Severe dry eye disease as determined by Schirmer's test less than 1mm in at least one eye

Total bilirubin greater than 2 times institutional upper limit of normal (except patients with known Gilbert's syndrome)

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Treatment Details

Interventions

CALEC Graft (Stem Cell Therapy)

Participant Groups

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.