Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543667
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-04
Brief Title:
Limbal Stem Cell Derived Exosome LSC-Exo Eye Drop for Treatment of Dry Eye
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Study for Safety and Efficacy Evaluation of Limbal Stem Cell Derived Exosome LSC-Exo Eye Drop for Treatment of Dry Eye Syndrome
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXOIUMS
Brief Summary:
The purpose of this study is to determine the safety and efficacy of Limbal Stem Cells derived Exosomes LSC-Exo in alleviation of dry eye symptoms
Detailed Description:
Dry eye is among the most prevalent chronic conditions in ophthalmology significantly impacting quality of life and presenting a public health challenge that cannot be overlooked Current treatment options primarily consist of artificial tear replacement anti-inflammatory therapies and local immunosuppressive treatments which mainly focus on alleviating discomfort and other symptoms associated with the ocular surface However with the rapid advancements in regenerative medicine ophthalmologists are exploring innovative approaches to treat dry eye Chronic dry eye can result in corneal damage and potential vision loss Recent studies suggest that therapeutic exosomes delivered as eye drops can enhance the immune microenvironment of the cornea and alter the ocular surface39s microenvironment for better outcomes
Exosomes are membrane vesicles secreted by parental cells which can mediate the transfer of RNA protein DNA and other functional molecules of the parent cell between other cells and regulate the function of target cells The therapeutic potential of Limbal Stem Cell Exosomes has been studied by our department We found that LSC-Exo can alleviate the symptoms of dry eye in the animal study At present we plan to clarify its efficacy in a clinical research
The main objective of this study is to evaluate the alleviation of Dry Eye symptoms in patients which are resist to conventional treatment by tear drops The assessment will be done after LSC-Exo treatment by measuring Ocular Surface Index Score OSDI and the second objective include the measurement of inflammatory and pro-inflammatory cytokines in tear of patients tear secretion amount tear break time the areas stained by fluorescent ocular redness tear meniscus and best corrected visual acuity
Approximately 30 patients will be recruited The treatment group will receive artificial tears for 2 weeks to normalize the baseline followed by intervention of LSC-Exo 10ugdrop four times a day for 30 days The follow-up visit will be 12-weeks and the progression of dry eye will be measured
Exosomes are membrane vesicles secreted by parental cells which can mediate the transfer of RNA protein DNA and other functional molecules of the parent cell between other cells and regulate the function of target cells The therapeutic potential of Limbal Stem Cell Exosomes has been studied by our department We found that LSC-Exo can alleviate the symptoms of dry eye in the animal study At present we plan to clarify its efficacy in a clinical research
The main objective of this study is to evaluate the alleviation of Dry Eye symptoms in patients which are resist to conventional treatment by tear drops The assessment will be done after LSC-Exo treatment by measuring Ocular Surface Index Score OSDI and the second objective include the measurement of inflammatory and pro-inflammatory cytokines in tear of patients tear secretion amount tear break time the areas stained by fluorescent ocular redness tear meniscus and best corrected visual acuity
Approximately 30 patients will be recruited The treatment group will receive artificial tears for 2 weeks to normalize the baseline followed by intervention of LSC-Exo 10ugdrop four times a day for 30 days The follow-up visit will be 12-weeks and the progression of dry eye will be measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None