Investigating the effectiveness of exosomes derived from placenta mesenchymal stem cells on improving the symptoms of interstitial lung fibrosis in systemic sclerosis patients, a single-arm clinical trial
Evaluation of the therapeutic efficiency of the placenta mesenchymal stem cell–derived exosomes on improvement of lung disease symptoms
Design
This study is a single-blinded clinical trial. The research population will include all systemic sclerosis patients referred to Imam Reza Hospital of Kermanshah. The number of 10 qualified patients will be selected in an accessible manner and will be included in the intervention group.
Settings and conduct
This study, which will be conducted at Imam Reza Hospital of Kermanshah, is single-blinded. Patients are informed about participating in the study and receiving the new drug, but they are blinded to which group will receive the new drug. The exosome sediment is suspended in 100 microliters of PBS and frozen at -80°C until use. Then, at the time of injection, it is dissolved in 100 cc of injectable physiological serum and injected at a rate of 2 ml/min.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of systemic sclerosis; Interstitial lung disease confirmed by chest CT scan and pulmonary function tests; Informed consent
Exclusion criteria: Suffering from other autoimmune diseases; Uncontrolled high blood pressure; Diabetes and other endocrine disorders; Cardiovascular failure; Chronic kidney failure; The presence of life-threatening complications including severe hemolysis of platelets below 40,000
Intervention groups
The intervention group will receive exosomes derived from stem cells with a dose between 5.2-1011 × 1011 (three sessions intravenously) particles/unit. There is no control group
Main outcome variables
lung involvement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N224
Registration date:2024-08-24, 1403/06/03
Registration timing:prospective
Last update:2024-08-24, 1403/06/03
Update count:0
Registration date
2024-08-24, 1403/06/03
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of exosomes derived from placenta mesenchymal stem cells on improving the symptoms of interstitial lung fibrosis in systemic sclerosis patients, a single-arm clinical trial
Public title
Evaluation of the therapeutic efficiency of the placenta mesenchymal stem cell–derived exosomes on improvement of lung disease symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of systemic sclerosis
Interstitial lung disease confirmed by chest CT scan and pulmonary function tests
Informed consent
Exclusion criteria:
Suffering from other autoimmune diseases
Uncontrolled high blood pressure
Diabetes and other endocrine disorders
Cardiovascular failure
Chronic kidney failure
Liver dysfunction
Depression
The presence of life-threatening complications including severe hemolysis of platelets below 40,000
Pregnancy and breastfeeding
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is a single-blinded one. Participants are kept blind to the dose of exosomes they receive
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-01-16, 1402/10/26
Ethics committee reference number
IR.KUMS.REC.1402.583
Health conditions studied
1
Description of health condition studied
Systemic sclerosis (scleroderma)
ICD-10 code
M34
ICD-10 code description
Systemic sclerosis [scleroderma]
Primary outcomes
1
Description
lung involvement
Timepoint
The beginning and end of the study (6 months later)
Method of measurement
Chest CT scan, pulmonary function tests and spirometry
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive exosomes derived from stem cells with a dose between 5.2-1011 × 1011 (three sessions intravenously) particles/unit.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Red Crescent Clinic
Full name of responsible person
Dr. Shirin Assar
Street address
Red Crescent Clinic, Kasra Street
City
Kermanshah
Province
Kermanshah
Postal code
6815747131
Phone
+98 83 3726 8082
Email
sh758us@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Shirin Assar
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
009883342276301
Email
sh758us@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Shirin Assar
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
009883342276301
Email
sh758us@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Shirin Assar
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
009883342276301
Email
sh758us@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD