The effect of Autologous Conditioned Serum on eye condition in patients with Sjogren syndrome
Design
Twenty patients were selected with Sjogren syndrome with dry eye in both eyes. After obtaining informed consent, they are classified into two groups with Autologous Conditioned Serum (ACS) treatment and control group by receiving artificial tears drop. Patients were randomly assigned to receive 10 cc of blood from a cubital vein injection and collected in an ACS syringe and used to produce ACS. For this purpose, blood in the syringe is incubated for 24 hours at 37 ° C to release growth and anti-inflammatory factors,The blood is then centrifuged at 3000 g for 10 minutes to remove the ACS. After separation, the ACS is filtered with a 0.22 μm filter and stored at -80 ° C until use.
Settings and conduct
Patients are referred to Nikukari Eye Hospital in Tabriz and the following items for the patients who are most relevant, recorded: Tear film breakup time (tBUT), Best corrected visual acuity (BCVA), Fluorescein staining, Rose Bengal staining, Tear film meniscus. After preparation of Autologous Conditioned Serum (ACS) and its quality control, it is delivered to patients for use as ordered by a physician. A second injection is repeated at intervals of 21 days. Then, in order to evaluate the effect of ACS on patients 3 months after the first use, the cases mentioned above will be recorded.
Participants/Inclusion and exclusion criteria
People between the ages of 25-40 years
Having Sjogren's Syndrome
The availability of individual during the study period
Intervention groups
ACS treatment group; control group recipients of artificial tears drop
Main outcome variables
Tear film breakup time (tBUT), Best corrected visual acuity (BCVA), Fluorescein staining, Rose Bengal staining, Tear film meniscus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160422027520N16
Registration date:2020-02-08, 1398/11/19
Registration timing:registered_while_recruiting
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Autologous Conditioned Serum on eye condition in patients with Sjogren syndrome
Public title
Treatment of eye problems in Sjogren syndrome with Autologous Conditioned Serum
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People between the ages of 25-40 years
Having Sjogren's Syndrome
The availability of individual during the study period
Exclusion criteria:
Having a financial incentive to participate in the study or Participate in another study simultaneously
Having eye problems for reasons other than Sjogren's syndrome
People with malignancy
People with diabetes
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
One patient's eye is considered as a control and one eye for intervention
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
تبریز- خیابان دانشگاه- دانشگاه علوم پزشکی تبریز
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-12-23, 1398/10/02
Ethics committee reference number
IR.TBZMED.REC.1398.1000
Health conditions studied
1
Description of health condition studied
Dry eye in Sjogren syndrome
ICD-10 code
M35.0
ICD-10 code description
Sicca syndrome [Sjogren]
Primary outcomes
1
Description
The effect of Autologous Conditioned Serum on eye condition in patients with Sjogren syndrome
Timepoint
3 months after using autologous conditioned serum injection
Method of measurement
With tests: Tear film breakup time (tBUT), Best corrected visual acuity (BCVA), Fluorescein staining, Rose Bengal staining, Tear film meniscus
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients receiving Autologous Conditioned Serum (ACS) as the intervention group. blood was taken by ACS-specific syringe, manufactured by Orthokin Co., for ACS preparation. Then patients are given ACS to pour 6 drops in one eye daily for 3 months.
Category
Treatment - Other
2
Description
Control group: patients receiving artificial tears drop as the control group. Patients are given artificial tears drop to pour 6 drops in one eye daily for 3 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikukari Eye Hospital
Full name of responsible person
Mehdi Yousefi
Street address
Nikukari Eye Hospital,Abbasi St,Tabriz, East Azerbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7767
Email
mehdi_yusefi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4667
Email
mahmoodpoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
yousefime@tbzmed.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available