To evaluate the safety and initial efficacy of exosome eye drops isolated from Wharton's jelly mesenchymal stem cells (MSC-Exo) in the treatment of dry eye diseases.
Design
The current study is a non-random, single arm, before and after intervention study with 30 people who suffering from dry eye diseases. Patients referred to the vision health clinic who meet the criteria for the study will be included in the study.
Settings and conduct
This study will conducted in the vision health clinic at Semnan University of Medical Sciences. Thirty patients with dry eye diseases will participate after normalization with artificial tears.
Eye drops contain exosomes derived from stem cells in two eyes, four times daily for 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Clinical diagnosis of dry eye symptoms by ophthalmologists;
These symptoms must be present in at least one eye: dryness, burning sensation, foreign body sensation, eye surface discomfort or visual fatigue;
Tear secretion test (Schirmer test) both eyes ≤ 10 mm / 5 minutes.
Exclusion exclusion:
being allergic to any of the drug components;
Pregnant or lactating women;
Patients with active fungal, bacterial or viral keratitis or conjunctivitis;
suffering from serious heart, lung, liver or kidney diseases;
other incurable eye diseases before the study Such as glaucoma, uveitis, retinitis pigmentosa
Intervention groups
Intervention: Administration of eye drops containing exosome of stem cells, 4 drops per day for 3 months in patients with severe dry eyes
Main outcome variables
The percentage of patients with increasing of Tear Film Break-up Time; Ocular Surface Staining
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170211032503N2
Registration date:2024-02-20, 1402/12/01
Registration timing:prospective
Last update:2024-02-20, 1402/12/01
Update count:0
Registration date
2024-02-20, 1402/12/01
Registrant information
Name
Hossein Aghamollaei
Name of organization / entity
Baqiyatallah University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 2260
Email address
abrcl@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-29, 1403/02/10
Expected recruitment end date
2024-12-30, 1403/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the therapeutic effect of eye drops obtained from Wharton's jelly stem cell exosomes in patients with severe dry eyes
Public title
Using exosome to treat severe dry eyes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with severe dry eye based on symptoms in at least one eye: dryness, burning sensation, foreign body sensation, discomfort in the ocular surface or visual fatigue
Failure to respond to routine treatments
Tear secretion test (Schirmer test) both eyes ≤ 10 mm / 5 minutes.
Exclusion criteria:
Those who are allergic to any of the drug components in this study.
Pregnant or lactating women
Patients with active fungal, bacterial or viral keratitis or conjunctivitis
Suffering from serious heart, lung, liver, or kidney diseases;
Patients with Diabetes
Age
From 18 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Headquarters of Smenan University of Medical Sciences, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.SEMUMS.REC.1402.235
Health conditions studied
1
Description of health condition studied
Severe dry eye
ICD-10 code
H04.129
ICD-10 code description
Dry eye syndrome of unspecified lacrimal gland
Primary outcomes
1
Description
The percentage of patients with increasing of Tear Film Break-up Time
Timepoint
Before intervention, one week, 4 weeks and 12 weeks after intervention
Method of measurement
The time required for dry spots to appear on the surface of the eye after blinking is in seconds. A positive change from baseline indicates improvement in each eye.
2
Description
Ocular Surface Staining
Timepoint
Before intervention, one week, 4 weeks and 12 weeks after intervention
Method of measurement
An area of the cornea that is stained with fluorescein dye and it will be assessed using a slate lamp microscope. Ocular surface damage will be measured by slit lamp examination after staining with non-toxic sodium fluorescein. Corneal and conjunctival staining will be graded based on the National Eye Institute (NEI) imaging scale. The lower the score has the less dry eye symptoms the patient. A negative change from baseline indicates improvement in each eye.
3
Description
The volume of tear
Timepoint
Before intervention, one week, 4 weeks and 12 weeks after intervention
Method of measurement
A paper strip is placed on the eye under the lower eyelid for a certain period of time. The length of the tear-soaked strip will be measured in millimeters. A positive change from baseline indicates improvement in each eye.
Secondary outcomes
1
Description
Uncorrected visual acuity
Timepoint
Before intervention, 1week, 1 month and 3 months after intervention
Method of measurement
Measurement of vision based on Snellen chart
2
Description
Best corrected visual acuity
Timepoint
Before intervention, 1week, 1 month and 3 months after intervention
Method of measurement
Measurement of vision based on Snellen chart
Intervention groups
1
Description
Intervention Group: A group of 30 individuals diagnosed with dry eye disease which will referred to the Vision Health Clinic will enrolled in the study. The medication consists of eye drops containing stem cell-derived exosomes, which the patient will instill into their eyes four times a day for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vision Health Research Center
Full name of responsible person
Hossein Aghamolaei
Street address
Unit 17, 5th floor, No. 8, Second Alley, Vali Asr Street
City
Tehran
Province
Tehran
Postal code
1516747418
Phone
+98 912 279 3682
Email
aghamolaei22@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vision health research center
Full name of responsible person
Khosrow Jadidi
Street address
Unit 17, 5th floor, No. 8, Second Alley, Vali Asr Street
City
Tehran
Province
Tehran
Postal code
1516747418
Phone
+98 912 105 3475
Email
kh.jadidi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
This study will not have any other financial source
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Vision health research center
Full name of responsible person
Hossein Aghamollaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical biotechnology
Street address
Unit 17, 5th floor, No. 8, Second Alley, Vali Asr Street
City
Tehran
Province
Tehran
Postal code
1516747418
Phone
+98 21 8819 6862
Email
aghamolaei22@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vision health research center
Full name of responsible person
Khosrow Jadidi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Unit 17, 5th floor, No. 8, Second Alley, Vali Asr Street
City
Tehran
Province
Tehran
Postal code
1516747418
Phone
+98 21 8819 6862
Email
kh.jadidi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Vision Health Research Center
Full name of responsible person
Mahsa Fallah Tafti
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Research Assistant
Street address
Unit 17, 5th floor, No. 8, Second Alley, Vali Asr Street
City
تهران
Province
Tehran
Postal code
1516747418
Phone
+98 21 8819 6862
Email
mahsafallah8@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the results obtained based on the disease improvement process along with the age and sex of the patient will be available.
When the data will become available and for how long
All the results obtained based on the disease improvement process along with the age and sex of the patient will be available after the completion of the three-month follow-up period.
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
In the case of obtaining permission from experts, the relevant applicants can access the data at the designated time. Only encrypted data and no personal patient profiles will be accessible.
From where data/document is obtainable
The email address along with the contact number of the respondents will be provided to the applicants
What processes are involved for a request to access data/document
After the completion of the three-month treatment period, after receiving an email from the applicant, the documents will be provided to the applicant.