Investigation the effect of intravenously injection of dental pulp mesenchymal stem cells in treatment of patients with pneumonia of COVID19 virus
Design
Clinical trial without control group, community based, not blinded, Non-randomised controlled study
Settings and conduct
This study is about infectious diseases. The location is Afzalipour Hospital and Stem Cell and regenerative medicine Comprehensive Cener of Kerman University of Medical Sciences. After the patient is selected by the physician, the dental pulp mesenchymal stem cells are injected intravenously at one time. Results are evaluated 14 and 28 days after injection.
Participants/Inclusion and exclusion criteria
A- Inclusion Criteria:
-Patients aged between 18-95 years
- Patients Approved for Covirus 19 by Laboratory Methods
-Presence of Corona virus pneumonia
B- Exclusion Criteria:
- Patients undergoing other clinical trials
-Patients who are resistant to routine treatment
Intervention groups
Dental pulp mesenchymal stem cells are injected into the patient at one time and followed for 14 and 28 days.
Main outcome variables
Pulmonary condition, RNA expression of COVID19 virus, Lymphocytes count, Study of clinical signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140911019125N6
Registration date:2020-04-04, 1399/01/16
Registration timing:registered_while_recruiting
Last update:2020-04-04, 1399/01/16
Update count:0
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32 24618
Email address
afarsinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2020-10-07, 1399/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of intravenous injection of dental pulp mesenchymal stem cells in treatment of patients with COVID-19 pneumonia
Public title
The effect of dental pulp mesenchymal stem cells in treatment of corona disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18-95 years
Patients Approved for Covirus 19 by Laboratory Methods
Exclusion criteria:
Patients undergoing other clinical trials
Patients with standard and routin treatments show progress in clinical signs
Age
From 18 years old to 95 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
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
Street address
Kerman university of medical science, Haft Bagh Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911333
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR.KMU.REC.1399.018
Health conditions studied
1
Description of health condition studied
Corona virus disease
ICD-10 code
U07.1
ICD-10 code description
COVID19, virus identified
Primary outcomes
1
Description
Pulmonary Condition
Timepoint
Before intervention and 14, 28 days after intervention
Method of measurement
CT scan
2
Description
Expression of nucleic acid of virus
Timepoint
Before intervention and 14 and 28 days after intervention
Method of measurement
real time PCR
3
Description
Lymphocytes count
Timepoint
Before intervention and 14 and 28 days after intervention
Method of measurement
Flowcytometry
4
Description
Patients clinical signs
Timepoint
before intervention and 14 and 28 days after intervention
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The extracted tooth is brought to the lab . After tooth extraction, it is enzymatically digested and cultured. After the cells have reached the required level, 40 million cells are injected intravenously at one time. Patients receive common medications at the same time.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Mehrdad Farrokhnia
Street address
Imam Khomeini Highway, Afzali pour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
Mehrdad_farrokhnia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Kerman university of medical science, Haft Bagh Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
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
Alireza Farsinejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Paramedical college, Kerman university of medical science, Haft Bagh Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Paramedical college, Kerman university of medical science, Haft Bagh Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Paramedical college, Kerman university of medical science, Haft Bagh Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
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
There is no additional data.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
In our study non of the personal data of patients will be shared. Only data that are related to outcomes of intervention will be shared.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
The data will be available for people working in academic institutions and clinicians.
Under which criteria data/document could be used
Applicants are only allowed to use received data in clinical and they are not allowed to published them
From where data/document is obtainable
1- Phone: 034-31325374 2- e-mail: afarsinejad@kmu.ac.ir 3- Fax: 034-31325375 4- address: Haft bagh Blvd, Kerman university of medical science Dr. Alireza Farsinejad
What processes are involved for a request to access data/document
Applicant can receive information after contact and send e-mail up to 10 days.