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Investigating the effect of exosomes with regenerative and anti-inflammatory potential derived from Wharton jelly mesenchymal stem cells on the treatment of corneal epithelial defects

Protocol summary

Study aim
Investigating the therapeutic potential of exosomes derived from Wharton jelly mesenchymal stem cells (MSCs-Exos) in patients with corneal epithelial defects.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 20 patients. We use different software such as (R or Python) for randomization
Settings and conduct
In sterile conditions, Wharton's jelly is separated and its mesenchymal cells are cultured. Finally, after stimulating the production of extracellular vesicles in closed conditions and in a sterile environment, ultracentrifugation will be used to separate the vesicles. After adding growth factors and cytokines and according to the protocol for 20 days, they will be used for the studied groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Male and female subjects 18 years and older. • People with PED for at least seven (7) days. • The defect may be of any size and must be measurable with a slit lamp. • In the researcher's opinion, CED is stable, that is, CED has not improved despite conventional treatments such as tear supplements and bandage contact lenses. • Primary corneal defects can be the result of injury, infection, disease, or eye surgery. Exit criteria: • Have any active eye infection (bacterial, viral, fungal, or protozoal) in the affected eye(s). • Patients who have received surgical treatment such as amniotic membrane transplantation or currently have an indication for surgical treatment. • Patients with eyelid abnormalities. • Patients with malignancy • Pregnant or breastfeeding patients
Intervention groups
intervention group, exosome-containing drops are used in people with corneal epithelial defects, and in the control group, normal treatment without the use of drops.
Main outcome variables
Improvement of epithelial defects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240706062337N1
Registration date: 2024-10-10, 1403/07/19
Registration timing: prospective

Last update: 2024-10-10, 1403/07/19
Update count: 0
Registration date
2024-10-10, 1403/07/19
Registrant information
Name
Fatemeh Sanie-Jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 2830
Email address
fsanie@sums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-17, 1403/09/27
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of exosomes with regenerative and anti-inflammatory potential derived from Wharton jelly mesenchymal stem cells on the treatment of corneal epithelial defects
Public title
Investigating the safety and efficacy of Wharton's jelly mesenchymal stem cell exosomes on corneal epithelium defects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants aged 18-65 years. Individuals diagnosed with corneal epithelial defects, confirmed by clinical examination and imaging techniques. Patients with moderate to severe corneal epithelial defects that have not responded to conventional treatments. Participants should be generally healthy, without systemic diseases that could affect the study outcomes. Written informed consent obtained from all participants. Patients who have not received any other experimental treatments for corneal epithelial defects in the past 6 months. No active ocular infections or other significant ocular diseases (e.g., glaucoma, uveitis) that could interfere with the study. Willingness and ability to comply with study procedures and follow-up visits.
Exclusion criteria:
Patients with uncontrolled systemic diseases such as diabetes, autoimmune disorders, or severe cardiovascular conditions. Presence of other significant ocular diseases (e.g., glaucoma, uveitis) or active ocular infections that could interfere with the study outcomes. Patients who have received other experimental treatments for corneal epithelial defects within the past 6 months. Known allergies to any components of the exosome preparation or related substances. Pregnant or breastfeeding women. Patients currently undergoing immunosuppressive therapy or with a history of organ transplantation. Inability or unwillingness to comply with study procedures and follow-up visits. Any other medical condition that, in the opinion of the investigator, could compromise the safety of the patient or the integrity of the study data.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
To create a random sequence, we use numbers to assign to participants using random functions in different software such as R or Python. We use the clinical characteristics of the patients to limit, and the division into groups is done based on the initial clinical condition of the person
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, double blinding was used to reduce the errors and conscious or unconscious effects of the researchers in measuring the outcomes. In this way, both patients and all researchers related to patients are unaware of the treatment received by the patient. Considering that this is a single-center study, by using a code, the patient is identified whether he received the active drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand St., in front of Palestine St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2024-07-08, 1403/04/18
Ethics committee reference number
IR.SUMS.REC.1403.123

Health conditions studied

1

Description of health condition studied
Corneal epithelium defects
ICD-10 code
H18.9
ICD-10 code description
Disorder of cornea, unspecified

Primary outcomes

1

Description
Improvement of epithelial defects
Timepoint
It is measured in weeks 1, 2 and 4
Method of measurement
Clinical examinations

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group : Description: Patients will receive exosomes derived from Wharton jelly mesenchymal stem cells (WJ-MSCs) with regenerative and anti-inflammatory potential. Exosomes are prepared in the cleanroom of the University of Medical Sciences. Dosage and administration: Exosomes are prepared as 10% dilution with tearlose and packaged in eye drops. The drops are prescribed topically on the affected eye(s) once a day for 4 weeks. Objective: To evaluate the efficiency of exosomes derived from WJ-MSC in improving corneal epithelial healing and reducing inflammation. Intervention group 2: Description: Patients will receive a standard treatment for corneal epithelial defects, such as tearlose artificial tears or conventional anti-inflammatory eye drops. Dosage and Administration: Standard treatment is performed according to usual clinical guidelines. Objective: To compare the effectiveness of standard treatment with exosome treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
POOSTCHI EYE CLINIC
Full name of responsible person
Fatima Sani Jahromi
Street address
Zand Blvd., in front of the Faculty of Medicine, at the beginning of Asadabadi St
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3233 0073
Email
fsanie@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Shiraz, Zand Street, Shiraz University of Medical Sciences Central Building, 7th Floor, Research and Technology Deputy
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Vice Chancellor for Research, Shiraz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahmoud Nejabat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Zand Blvd., in front of the Faculty of Medicine, at the beginning of Asadabadi St
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3233 0073
Email
psorc@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatima Sani Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
سلولی و مولکولی
Street address
Zand Blvd., in front of the Faculty of Medicine, at the beginning of Asadabadi St
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3233 0073
Email
fsanie@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatima Sani Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
سلولی و مولکولی
Street address
Zand Blvd., in front of the Faculty of Medicine, at the beginning of Asadabadi St
City
Shiraz
Province
Fars
Postal code
7134997446
Phone
+98 71 3233 0073
Email
fsanie@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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