Limbal Stem Cell Derived Exosome (LSC-Exo) Eye Drop for Treatment of Dry Eye

NCT ID: NCT06543667

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-07-01

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 surface's 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 10ug/drop, four times a day for 30 days. The follow-up visit will be 12-weeks and the progression of dry eye will be measured.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Limbal Stem Cell Derived Exosome Eye Drop treatment

Patients will receive artificial tears for 2 weeks to get the normalized baseline, followed by LSC-Exo eye drop intervention for 3 months.

Group Type: EXPERIMENTAL

Limbal Stem Cell Derived Exosomes Eye Drop

Intervention Type: BIOLOGICAL

Patients will receive artificial tears for 2 weeks to get the normalized baseline, followed by LSC-Exo eye drops 0.15 ml/single eye/one time, four times a day for 3 months. The follow-up visit will be 12 weeks since the administration of LSC-Exo eye drops.

Interventions

Limbal Stem Cell Derived Exosomes Eye Drop

Patients will receive artificial tears for 2 weeks to get the normalized baseline, followed by LSC-Exo eye drops 0.15 ml/single eye/one time, four times a day for 3 months. The follow-up visit will be 12 weeks since the administration of LSC-Exo eye drops.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients with complaints of burning or itching or feeling of a foreign body in the eye
• Moderate and severe dry eye severity
• Age between 18-70 years

Exclusion Criteria

• Previous history of eye surgery
• Any disease that suppresses the immune system
• Pregnancy and breastfeeding
• Eyelid abnormalities
• Use of eye drops in the past year except artificial tears and lubricating ointments
• Use of systemic drugs that affect the tear film in last three months
• Use of contact lenses in the last three months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Alireza Shoae Hassani

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Moheb Kowsar Hospital

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Hossein Aghaei, MD

Role: CONTACT

draghaei.h@gmail.com

+982155661188

Alireza Shoae-Hassani

Role: CONTACT

cell.therapy@yahoo.com

+989121454878

Facility Contacts

Kian Alirezaei, MD

Role: primary

Kian.alirezaei.72@gmail.com

+989034561467

References

Randall Harrell C, Djonov V, Volarevic A, Arsenijevic A, Volarevic V. Mesenchymal Stem Cell-Sourced Exosomes as Potentially Novel Remedies for Severe Dry Eye Disease. J Ophthalmol. 2025 Jan 10;2025:5552374. doi: 10.1155/joph/5552374. eCollection 2025.

Reference Type: DERIVED

PMID: 39839752 (View on PubMed)

Other Identifiers

1358-06

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRCT20231022059814N1

Identifier Type: -

Identifier Source: org_study_id