Evaluation of the therapeutic effect of nebulized addipose tissue- derived mesenchymal stem cells conditioned media on covid -19 pneumonia
Design
Includes 15 patients who will receive the optimal culture medium by inhalation for 8 days in two doses at 8:30 in the morning and 4 in the afternoon.
This study will be performed in phase 0.
The control group includes patients whose symptoms were recorded on the first day of admission and will be compared with the results of their recovery on the day of discharge.
Settings and conduct
The present study will be performed at Kerman University of Medical Sciences, Afzalipour Hospital. Thus, after isolation and expansion of mesenchymal stem cells, their optimal conditioned media was isolated and after reaching the appropriate concentration will be nebulized by nebulizer in 15 patients hospitalized with Covid 19 for 5 days and in Used twice a day. One and three days after receiving the last dose of treatment, people's recovery will be evaluated.
Participants/Inclusion and exclusion criteria
Patients with Covid 19 who have been infected for a week and who have been hospitalized for 48 hours despite receiving medication and oxygen have not improved their condition and their arterial blood oxygen saturation percentage is below 88%.،
Patients with arterial blood oxygen saturation above 88%.
Intervention groups
experimental group: Includes 15 patients who will receive the optimal culture medium by inhalation for 8 days in two doses at 8:30 in the morning and 4 in the afternoon.
control group: The control group includes patients whose symptoms were recorded on the first day of admission and will be compared with the results of their recovery on the day of discharge.
Main outcome variables
CRP, Lung fibrosis, number of WBC, fever, LDH
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210919052520N1
Registration date:2022-01-13, 1400/10/23
Registration timing:registered_while_recruiting
Last update:2022-01-13, 1400/10/23
Update count:0
Registration date
2022-01-13, 1400/10/23
Registrant information
Name
Mona Saheli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3331 6308
Email address
m.saheli@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of nebulized addipose tissue- derived mesenchymal stem cells conditioned media on covid -19 pneumonia
Public title
Inhalation of stem cell products in patients with covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Covid 19 who have been infected for a week and who have been hospitalized for 48 hours despite receiving medication and oxygen have not improved their condition and their arterial blood oxygen saturation percentage is below 88%.
Exclusion criteria:
Patients with arterial blood oxygen saturation above 88%.
Age
To 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of kerman university of medical sciences
Treatment of patients suffer from Covid 19 nebulization of conditioned-medium derived from human adipose tissue mesenchymal stem cell
Timepoint
Comparison of the improvement of patients with covid-19 disease before the intervention and after 5 days of therapeutic intervention
Method of measurement
blood laboratory test , CT-Scan
Secondary outcomes
1
Description
Reduction of lung damage
Timepoint
Measurement of lung damage before and after therapeutic intervention
Method of measurement
CT-Scan
2
Description
CRP, LDH, WBC measurement
Timepoint
Before and after therapeutic intervention
Method of measurement
blood laboratory test
3
Description
fever
Timepoint
Before and after therapeutic intervention
Method of measurement
Thermometer
Intervention groups
1
Description
Intervention group: Includes 15 patients who will receive the conditioned-medium by nebulization for 8 days in two doses at 8:30 in the morning and 4 in the afternoon.
Category
Treatment - Drugs
2
Description
Control group: The control group includes patients whose symptoms were recorded on the first day of admission and will be compared with the results of their recovery on the day of discharge.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Mona Saheli, Meisam Yousefi
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Fax
+98 34 3132 8000
Email
saheli.mona@gmail.com
Web page address
https://ah.kmu.ac.ir/fa
2
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Mona Saheli, Meisam Yousefi
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
کرمان
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
saheli.mona@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mona Saheli
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
saheli.mona@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mona Saheli
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616614115
Phone
+98 34 3325 7666
Email
saheli.mona@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mona Saheli
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3325 7666
Email
saheli.mona@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mona Saheli
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3325 7666
Email
saheli.mona@gmail.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data of our study include information on the status and biochemical characteristics of patients after treatment.
When the data will become available and for how long
one year after
To whom data/document is available
general publication
Under which criteria data/document could be used
To treat patients if treatment is successful and publicly disseminate data
From where data/document is obtainable
principle investigator
What processes are involved for a request to access data/document
The applicant submits the request via email to the executor and receives a response.