Evaluation of the therapeutic efficiency of the placenta mesenchymal stem cell-derived exosomes on the improvement of interstitial lung disease symptoms in systemic sclerosis patients, a single-arm trial.
Evaluation of the therapeutic efficiency of the placenta mesenchymal stem cell-derived exosomes on the improvement of interstitial lung disease symptoms in systemic sclerosis patients
Design
This is a single-blinded clinical trial. In this single-blinded study, participants were kept blind to the exosome dose. This randomized study will be performed on 10 patients with systemic sclerosis with severe pulmonary fibrosis.
Settings and conduct
This single-blinded study will be performed in Imam Reza hospital of Kermanshah. Due to the systemic nature of the disease process, the involvement of pulmonary fibrosis is generally bilateral and not unilateral, and in this plan, the opinion and radiologist report is the criterion for determining the severity of pulmonary fibrosis and quantification.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; American College of Rheumatology (ACR) and EULAR2013 diagnostic criteria for systemic sclerosis
Intestinal lung disease confirmed by chest CT scan and lung function tests
Exclusion criteria: Suffering from other autoimmune diseases; Uncontrolled high blood pressure, diabetes and other endocrine disorders; Cardiovascular failure; Hepatic impairment; Existence of life-threatening conflicts including severe platelet hemolysis below 40,000; Pregnancy and lactation
Intervention groups
In addition to standard treatment (cyclophosphamide and mycophenolate mofetil), the intervention group will receive exosomes derived from placenta mesenchymal stem cells in three sessions two weeks apart.
Main outcome variables
Rate of pulmonary involvement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N184
Registration date:2022-04-16, 1401/01/27
Registration timing:prospective
Last update:2022-04-16, 1401/01/27
Update count:0
Registration date
2022-04-16, 1401/01/27
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
2022-04-18, 1401/01/29
Expected recruitment end date
2022-07-20, 1401/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic efficiency of the placenta mesenchymal stem cell-derived exosomes on the improvement of interstitial lung disease symptoms in systemic sclerosis patients, a single-arm trial.
Public title
Evaluation of the therapeutic efficiency of the placenta mesenchymal stem cell-derived exosomes on the improvement of interstitial lung
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
American College of Rheumatology (ACR) and EULAR2013 diagnostic criteria for systemic sclerosis
Intestinal lung disease confirmed by chest CT scan and lung function tests
Exclusion criteria:
Suffering from other autoimmune diseases
Uncontrolled high blood pressure, diabetes, and other endocrine disorders
Cardiovascular failure
Chronic renal failure
Hepatic impairment
Depression
Existence of life-threatening conflicts including severe platelet hemolysis below 40,000
Pregnancy and lactation
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
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
2022-01-10, 1400/10/20
Ethics committee reference number
IR.KUMS.REC.1400.794
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
Rate of pulmonary involvement
Timepoint
Before and after the intervention (4-6 weeks later)
Method of measurement
Using CT scan
Secondary outcomes
empty
Intervention groups
1
Description
In addition to standard treatment (cyclophosphamide and mycophenolate mofetil), the intervention group will receive exosomes derived from placenta mesenchymal stem cells in three sessions two weeks apart.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dena Mohamadzadeh
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
denamohamadzadeh75@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
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
rkhodarahmi@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
Dena Mohamadzadeh
Position
Resident of Internal
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
denamohamadzadeh75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Shirin Asar
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
sh758us@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dena Mohamadzadeh
Position
Resident of Internal
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
denamohamadzadeh75@gmail.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