cLSC for Limbal Stem Cell Deficiency (LSCD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Limbal Stem Cell Deficiency (LSCD)
cLSC - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether it is feasible and safe to transplant cells onto the cornea to treat a disease.

Treatment Effectiveness

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: At 6 months and 12 months in both cLSC and the control groups

Month 12
Feasibility of cLSC Transplant pertaining to Manufacturing meeting Release Criteria
Feasibility of cLSC Transplant pertaining to Manufacturing without Contamination
Safety of cLSC Transplant pertaining to Infection and/or Corneal Perforation
Month 12
Changes in the Area of Corneal Epithelial Defect
Changes in the Clinical Score

Trial Safety

Trial Design

2 Treatment Groups

Scleral Contact Lens Device (SCL)
1 of 2
Cultivated Limbal Stem-Cells (cLSC)
1 of 2

Active Control

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: cLSC · No Placebo Group · Phase 1

Cultivated Limbal Stem-Cells (cLSC)
Biological
Experimental Group · 1 Intervention: cLSC · Intervention Types: Biological
Scleral Contact Lens Device (SCL)
Device
ActiveComparator Group · 1 Intervention: Scleral contact lens (SCL) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 6 months and 12 months in both clsc and the control groups

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,405 Previous Clinical Trials
6,941,279 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
57 Previous Clinical Trials
3,039 Total Patients Enrolled
National Eye Institute (NEI)NIH
515 Previous Clinical Trials
1,072,916 Total Patients Enrolled
Sophie Deng, MD, PhD4.840 ReviewsPrincipal Investigator - Stein Eye Institute UCLA
5Patient Review
The provider was everything I hoped for — professional, knowledgeable, and courteous. I would recommend them without hesitation.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person has a best corrected visual acuity of 20/200 or worse in the affected eye.
is associated with a good prognosis in patients with retinitis pigmentosa The absence of eyelid abnormalities and lagophthalmos is associated with a good prognosis in patients with retinitis pigmentosa.
LSCD is not cured by surgical treatments of the ocular surface during the previous 6 months of screening visit.
The depth of the forniceal sulcus should be ≥ 5 mm.
If LSCD is caused by chemical injury, at least 1 year must have passed since the initial injury for eligibility.
A Schirmer test result of 5 mm or more of wetting in 5 minutes.
A person who is male or female and at least 18 years old.
There is documentation of a LSCD diagnosis and it is clear that the central cornea is affected.
There was no active infection present in either eye when they enrolled.
People who enroll in the study must have a life expectancy of more than two years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.