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Stem Cell Therapy
Stem Cell Transplant for Limbal Stem Cell Deficiency
Phase 1
Recruiting
Led By Sophie Deng, MD, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absence of lagophthalmos and eyelid abnormality
Documentation of a LSCD diagnosis and the central cornea is affected
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months and 12 months in both clsc and the control groups
Awards & highlights
Study Summary
This trial will test whether it is feasible and safe to transplant cells onto the cornea to treat a disease.
Who is the study for?
This trial is for adults over 18 with Limbal Stem Cell Deficiency (LSCD) that hasn't improved after surgery in the last 6 months. Participants must have a vision of 20/200 or worse, diagnosed LSCD affecting the central cornea, no eyelid issues, and adequate eye moisture. Not eligible if pregnant, breastfeeding without birth control use during study, had chemical injury within last year, allergic to cLSC components, in another trial currently or have uncontrolled diabetes.Check my eligibility
What is being tested?
The study tests cLSC's ability to be manufactured and transplanted onto patients' corneas successfully at surgery time. It aims to see if these cells can populate the ocular surface effectively without causing serious adverse events.See study design
What are the potential side effects?
While specific side effects are not listed here as it's an early phase I trial focusing on feasibility and safety of cLSC transplantation for LSCD treatment; potential risks may include infection risk at surgical site or immune reaction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eyelids close completely without any abnormalities.
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My diagnosis is LSCD and it affects the center of my cornea.
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I do not have an active eye infection.
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My eye's forniceal depth is at least 5 mm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months and 12 months in both clsc and the control groups
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months and 12 months in both clsc and the control groups
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Changes in the Area of Corneal Epithelial Defect
Changes in the Clinical Score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cultivated Limbal Stem-Cells (cLSC)Experimental Treatment1 Intervention
One dose of cultivated limbal stem-cells (cLSC), size between 7.6 to 15 mm in the average diameter.
Group II: Scleral Contact Lens Device (SCL)Active Control1 Intervention
Scleral contact lens device (SCL) will be fitted to stabilize and improve ocular surface.
Find a Location
Who is running the clinical trial?
California Institute for Regenerative Medicine (CIRM)OTHER
64 Previous Clinical Trials
3,137 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,264,688 Total Patients Enrolled
National Eye Institute (NEI)NIH
547 Previous Clinical Trials
1,402,137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My eyelids close completely without any abnormalities.My eye is affected by exposure or cannot fully close.I have a tumor on the surface of my eye.My diagnosis is LSCD and it affects the center of my cornea.My eye surface condition didn't improve after surgery in the last 6 months.I do not have an active eye infection.I experienced a chemical injury within the last year.You have known allergies to any of the ingredients used in the cLSC (clinical trial).It has been over a year since my eye was damaged by chemicals.I have ongoing severe eye inflammation or eyelid gland issues.My eye's forniceal depth is at least 5 mm.
Research Study Groups:
This trial has the following groups:- Group 1: Cultivated Limbal Stem-Cells (cLSC)
- Group 2: Scleral Contact Lens Device (SCL)
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.
To what extent could cLSC be detrimental to patients?
"Limited prior evidence of cLSC's safety and efficacy results in it being rated a 1 on the scale."
Answered by AI
Are there any available slots in this research program that are accessible to participants?
"Clinicaltrials.gov states that this medical experiment is actively recruiting volunteers, having first been posted on September 30th 2020 and recently updated on December 29th 2021."
Answered by AI
To what extent has this clinical trial managed to recruit participants?
"That is correct. Evidenced by the details provided on clinicaltrials.gov, this medical trial—which was first published on September 30th 2020—is actively searching for 20 participants from one location."
Answered by AI
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