Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2020-09-30
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cultivated Limbal Stem-Cells (cLSC)
One dose of cultivated limbal stem-cells (cLSC), size between 7.6 to 15 mm in the average diameter.
cLSC
Transplantation of cLSC
Scleral Contact Lens Device (SCL)
Scleral contact lens device (SCL) will be fitted to stabilize and improve ocular surface.
Scleral contact lens (SCL)
Scleral contact lens device (SCL) will be used to stabilize and improve ocular surface.
Interventions
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cLSC
Transplantation of cLSC
Scleral contact lens (SCL)
Scleral contact lens device (SCL) will be used to stabilize and improve ocular surface.
Eligibility Criteria
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Inclusion Criteria
2. Best corrected visual acuity in the affected eye of 20/160 or less.
3. Documentation of a LSCD diagnosis and the central cornea is affected.
4. Absence of lagophthalmos and eyelid abnormality
5. Adequate forniceal depth is ≥ 5 mm.
6. LSCD fails to resolve by surgical treatments of the ocular surface during the previous 6 months of screening visit.
7. If the etiology of LSCD is due to chemical injury, a minimal interval of 1 year since the initial chemical injury is required.
8. A Schirmer test result at 5 minute of ≥5 mm of wetting.
9. Absence of active infectious keratitis in either eye at the Enrollment Visit.
10. Have a life expectancy ≥ 2 years after enrollment.
Exclusion Criteria
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
3. Exposure keratopathy or lagophthalmos of the study eye.
4. Persistent severe ocular surface inflammation and/or meibomian gland dysfunction
5. Chemical injury occurred less than 12 months ago.
6. Presence of ocular surface tumor.
7. Uncontrolled diabetes with last hemoglobin A1C (HgA1C) \>8.5.
8. Presence of known allergies to any of the cLSC components.
9. Current participation in another simultaneous medical investigation or trial.
10. Unable to be compliant with or complete the requirements of the study.
18 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
California Institute for Regenerative Medicine (CIRM)
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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Sophie Deng, MD, PhD
Professor
Principal Investigators
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Sophie Deng, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stein Eye Institute UCLA
Locations
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University of California
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Clemence Bonnet, MD
Role: primary
Other Identifiers
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V001
Identifier Type: -
Identifier Source: org_study_id
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