Protocol summary

Study aim
Investigation the effect of intravenous injection of dental pulp mesenchymal stem cells in treatment of patients with COVID-19 pneumonia- A Phase 2&3 Clinical Trial
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 3 and 2 on 120 patients. A simple randomization method is used for randomization.
Settings and conduct
This study is performed in the field of infectious diseases. It is located in Afzalipour Hospital and the Comprehensive Center for Stem Cells and Regenerative Medicine of Kerman University of Medical Sciences. In this study, 2 groups are intervened. Both groups receive conventional therapies. In addition, in the first group, patients have oxygen masks and receive stem cells, and in the second group, patients receive intubation and receive mesenchymal stem cells.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged between 18-95 years Patients Approved for Covirus 19 by Laboratory Methods Patients with mild to moderate respiratory distress Hospitalization in the ICU Exclusion criteria: Patients undergoing other clinical trials Patients with underlying diseases including diabetes, heart disease, respiratory disease, cancer patients and patients undergoing chemotherapy
Intervention groups
Two groups of patients are involved in this study. The first group uses an oxygen mask. The second group is patients admitted to the ICU who are intubated. Both groups receive mesenchymal stem cells in addition to conventional therapies. In addition to these two intervention groups, there are two control groups, the first group receiving only oxygen masks and conventional therapies, and the second group of patients admitted to the ICU receiving only conventional therapies.
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: IRCT20140911019125N8
Registration date: 2020-09-26, 1399/07/05
Registration timing: registered_while_recruiting

Last update: 2020-09-26, 1399/07/05
Update count: 0
Registration date
2020-09-26, 1399/07/05
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32 24618
Email address
afarsinejad@kmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-09-10, 1399/06/20
Expected recruitment end date
2021-03-10, 1399/12/20
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- A Phase 2&3 Clinical Trial
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 Patients with mild to moderate respiratory distress Hospitalization in the ICU
Exclusion criteria:
Patients undergoing other clinical trials Patients with underlying diseases including diabetes, heart disease, respiratory disease, cancer patients and patients undergoing chemotherapy.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method is used.
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 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
2020-09-16, 1399/06/26
Ethics committee reference number
IR.KMU.REC.1399.373

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
At the beginning of the study and 1 day and 2 days, 4 days, 7 days and 14 days after the start of the study
Method of measurement
CT scan

2

Description
Expression of nucleic acid of virus
Timepoint
At the beginning of the study and 1 day and 2 days, 4 days, 7 days and 14 days after the start of the study
Method of measurement
real time PCR

3

Description
Lymphocytes count
Timepoint
At the beginning of the study and 1 day and 2 days, 4 days, 7 days and 14 days after the start of the study
Method of measurement
Flowcytometry

4

Description
Patients clinical signs
Timepoint
At the beginning of the study and 1 day and 2 days, 4 days, 7 days and 14 days after the start of the study
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The extracted tooth is brought to the laboratory. After separating the tooth pulp, it is digested enzymatically and cultured. Once the cells have reached a sufficient level, 40 million cells are injected intravenously into the patient at a time. These patients are patients admitted to the ICU who use an oxygen mask and receive stem cells upon arrival at the ICU in addition to routine treatments.
Category
Treatment - Other

2

Description
Intervention group: The extracted tooth is brought to the laboratory. After separating the tooth pulp, it is digested enzymatically and cultured. Once the cells have reached a sufficient level, 40 million cells are injected intravenously into the patient at a time. These patients are hospitalized in an ICU that is intubated and, in addition to the usual treatments, receive stem cells at the time of connection to the device.
Category
Treatment - Other

3

Description
Control group: ICU patients who wear oxygen masks receive only routine treatment and are monitored from the time they enter the ICU.
Category
N/A

4

Description
Control group: Patients admitted to the ICU who are intubated and receive only routine treatments are monitored upon connection to the device.
Category
N/A

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
Fax
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.
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