Mesenchymal stem cell utilization in reducing complications and enhancing pneumonia healing in patients infected with 2019-nCoV (phase I clinical trial)
Evaluation of mesenchymal stem cell therapy in the treatment of patients with COVID-19 disease
Design
Experimental: Mesenchymal Stem Cells ( MSC) Treatment Group
Conventional treatment plus MSCs Participants will receive conventional treatment plus 3 times of MSCs(7.0*10E7 MSCs intravenously at Day 0, Day 3, Day 6)., 5 patients, clinical trial phaseI
No Intervention: Conventional Control Group
Without MSCs Therapy but conventional treatment should be received.
Settings and conduct
Place of study and treatment of hospitalized patients in Baqiyatallah Hospital,After validation of Critria with Mesenchymal Stem Cell Therapy was performed on days 0, 3 and 6.The Therapist physician and the researcher are different.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. Blood oxygenation saturation <93% 2. Abnormal lung CT scan 3. Significant shortness of breath 4. Fever 5. Not improving in the next 48 hours 6. There is no possibility of discharge of patient in the next 48 hours 7. Patient consent
Exclusion criteria 1. The patient should not be connected to a ventilator . 2. The patient has not given consent.
Intervention groups
Patients with confirmed COVID-19 disease
Main outcome variables
mortality rate; duration of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200325046860N2
Registration date:2020-04-01, 1399/01/13
Registration timing:registered_while_recruiting
Last update:2020-04-01, 1399/01/13
Update count:0
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Hassan Abolghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 3166
Email address
h.abolghasemi.ha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-28, 1399/01/09
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
2020-03-28, 1399/01/09
Actual recruitment end date
2020-04-18, 1399/01/30
Trial completion date
2020-04-29, 1399/02/10
Scientific title
Mesenchymal stem cell utilization in reducing complications and enhancing pneumonia healing in patients infected with 2019-nCoV (phase I clinical trial)
Public title
Mesenchymal Stem Cell therapy in COVID19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female, aged at 18 years (including) -70 years old
Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source
Pneumonia that is judged by chest radiograph or computed tomography.
Resp rate> 30, o2 sat < 93%,
Exclusion criteria:
Pregnancy, lactation
Patients with malignant tumor, other serious systemic diseases and psychosis
Patients who are participating in other clinical trials;
Inability to provide informed consent
Co-Infection of HIV, tuberculosis, influenza virus
Age
From 18 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
More than 1 sample in each individual
Number of samples in each individual:
5
2019 Novel Coronavirus Pneumonia
Actual sample size reached:
5
More than 1 sample in each individual
Actual sample size in each individual:
5
2019 Novel Coronavirus Pneumonia
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Baqiatallah university of medical sciences
Street address
Hemmat HW, sheikh bahaaei
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-03-26, 1399/01/07
Ethics committee reference number
IR.BMSU.REC.1399.007
Health conditions studied
1
Description of health condition studied
COVID-19 Disease
ICD-10 code
U07.02
ICD-10 code description
COVID-19 Disease
Primary outcomes
1
Description
respiratory function of patients
Timepoint
Every 24 hours after MSC infusion
Method of measurement
Clinical, lab test , CT scan
Secondary outcomes
empty
Intervention groups
1
Description
Treatment group: Patients with confirmed COVID-19 infection who in addition to their current treatment will be infused with 70 million mesenchymal stem cell day 0, 3 6 , infusion time 30 min 4.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiatallah general hospital
Full name of responsible person
Hasan Abolghasemi
Street address
Hemmat HW, sheikh Bahaaei st
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 3791
Email
h.abolghasemi.ha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hasan Abolghasemi
Street address
Hemmat HW, sheikh Bahaaei st
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 3791
Email
h.abolghasemi.ha@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Baqiatallah university of medical sciences, HORCSCT
Proportion provided by this source
50
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hasan Abolghasemi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Hemmat HW, sheikh bahaaei
City
Tehran
Province
Tehran
Postal code
1435916451
Phone
+98 21 8126 3799
Email
h.abolghasemi.ha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hasan abolghasemi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Hemmat HW , sheikh bahaaei
City
Tehra
Province
Tehran
Postal code
1435916471
Phone
+98 21 8126 3791
Email
h.abolghasemi.ha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hasan Abolghasemi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Hemmat Hw, sheikh bahaaei
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8126 2799
Email
h.abolghasemi.ha@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Clinical finding, lab test result, CT scan report,
When the data will become available and for how long
2 months after complete data
To whom data/document is available
Scientists, researcher
Under which criteria data/document could be used
All data sharing
From where data/document is obtainable
Hassan Abolghasmi via phone no. Or email
What processes are involved for a request to access data/document