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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
Must not have
Exposure keratopathy or lagophthalmos of the study eye
Presence of ocular surface tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months and 12 months in both clsc and the control groups
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment using lab-grown stem cells to repair severe eye damage in patients who have had injuries or surgeries. The goal is to see if these stem cells can safely and effectively help the eye heal. Stem cell therapy has been increasingly used for treating various diseases, including eye conditions, with limbal epithelial stem transplantation being the only eye-related cell therapy currently in clinical practice.
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.
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.
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.
Select...
My diagnosis is LSCD and it affects the center of my cornea.
Select...
I do not have an active eye infection.
Select...
My eye's forniceal depth is at least 5 mm.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My eye is affected by exposure or cannot fully close.
Select...
I have a tumor on the surface of my eye.
Select...
I have ongoing severe eye inflammation or eyelid gland issues.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Changes in the Area of Corneal Epithelial Defect
Changes in the Clinical Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Limbal Stem Cell Deficiency (LSCD) include limbal stem cell transplantation and the use of bioengineered corneal epithelial cells. These treatments work by replenishing the depleted or dysfunctional limbal stem cells, which are crucial for maintaining and regenerating the corneal epithelium.
For instance, cLSC (Corneal Limbal Stem Cells) therapy involves transplanting cultivated limbal stem cells onto the cornea, promoting the regeneration of a healthy corneal surface. This is vital for LSCD patients as it restores the corneal barrier, improves vision, and prevents further damage or scarring, thereby significantly enhancing their quality of life.
Find a Location
Who is running the clinical trial?
California Institute for Regenerative Medicine (CIRM)OTHER
69 Previous Clinical Trials
3,342 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,568 Previous Clinical Trials
10,314,252 Total Patients Enrolled
National Eye Institute (NEI)NIH
558 Previous Clinical Trials
1,408,451 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.
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.