The therapeutic efficiency and immunogenic assessments of the placenta mesenchymal stem cell–derived exosomes on alleviation of symptoms in patients with lupus (a clinical trials)
Efficacy and safety of exosomes derived from placenta mesenchymal stem cells in improving the symptoms of patients with lupus
Design
This is a randomized clinical trial design with a parallel design, with the control group and not blinded. This study randomized, phase 2-3 study will be performed on 20 patients with lupus. Random blocks are used for randomization and participants are assigned to two intervention and control groups .
Settings and conduct
This study, which will be performed at the Kermanshah Biological Research Center, is not blinded. Researchers and participants have no role in the process of randomization and assignment of intervention and control groups. Data collection will be done by a rheumatologist. The patient's clinical and laboratory signs are recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Class 3 or 4 resistant lupus nephritis;
Parenchymal lung involvement or refractory heart involvement; Resistant vasculitis; Resistant CNS involvement
Exclusion criteria: Other autoimmune diseases; Severe renal failure and need to dialysis; Uncontrolled high blood pressure; diabetes and other endocrine disorders
Intervention groups
The intervention group will receive the conventional treatment with exosomes derived from a single source of placenta mesenchymal stem cells (first one-tenth of the mesenchymal exosomes are injected. If no side effects are observed within two days, the unit values are gradually increased within two weeks, up to 4 units will be given intravenously).
The control group will receive only the usual treatment.
The therapeutic efficiency and immunogenic assessments of the placenta mesenchymal stem cell–derived exosomes on alleviation of symptoms in patients with lupus (a clinical trials)
Public title
Efficacy stem cells in improving the symptoms of patients with lupus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Class 3 or 4 resistant lupus nephritis
Parenchymal lung involvement or refractory heart involvement
Resistant vasculitis
Resistant CNS involvement
Exclusion criteria:
Other autoimmune diseases
Uncontrolled high blood pressure
Diabetes and other endocrine disorders
Cardiovascular failure
Severe renal failure and need to dialysis
Hepatic impairment
Depression
Endocarditis
Lupus pneumonia
Pregnancy and breast-feeding
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization method with 4 blocks (5 blocks of 4). A random sequence will be created by an epidemiologist using the site https://www.sealedenvelope.com.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
2021-06-08, 1400/03/18
Ethics committee reference number
IR.KUMS.REC.1400.198
Health conditions studied
1
Description of health condition studied
Systemic lupus erythematosus
ICD-10 code
M32
ICD-10 code description
Systemic lupus erythematosus (SLE)
Primary outcomes
1
Description
Anti-Nuclear Antibody (ANA)
Timepoint
2 to 3 days after injection every 6 to 8 weeks
Method of measurement
Taking blood from the arm area
2
Description
Antiphospholipid antibodies
Timepoint
2 to 3 days after injection every 6 to 8 weeks
Method of measurement
In the laboratory with a blood test
3
Description
Glucose
Timepoint
2 to 3 days after injection every 6 to 8 weeks
Method of measurement
In the laboratory with a blood test
4
Description
triglyceride
Timepoint
2 to 3 days after injection every 6 to 8 weeks
Method of measurement
In the laboratory with a blood test
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive the conventional treatment(Such as hydroxychloroquine) with exosomes derived from a single source of placenta mesenchymal stem cells (first one-tenth of the mesenchymal exosomes are injected. If no side effects are observed within two days, the unit values are gradually increased within two weeks, up to 4 units will be given intravenously).
Category
Treatment - Other
2
Description
The control group will receive only the usual treatment (Such as hydroxychloroquine).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Biology Research Center
Full name of responsible person
Shima Famil Samavati
Street address
Medical Biology Research Center, Parasta Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714415185
Phone
+98 83 3427 6473
Email
sh.famil.s@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
کرمانشاه
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
Shima Famol Samavati
Position
PhD student in Biochemistry
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Medical Biology Research Center, Parasta Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714415185
Phone
+98 83 3427 6473
Email
sh.famil.s@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Kamran Mansouri
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Hematology
Street address
Medical Biology Research Center, Parasta Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714415185
Phone
009883334276473
Email
kamranmansouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shima Famil Samavati
Position
PhD student in Biochemistry
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Medical Biology Research Center, Parasta Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714415185
Phone
+98 83 3427 6473
Email
sh.famil.s@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