Protocol summary

Study aim
Evolution of Allogenic Mesenchymal stem cell- derived Umbilical cord transplantation for ARDS patients infected with COVID19
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
Randomise intervention, Ghaem Hospital, Mashhad
Participants/Inclusion and exclusion criteria
Covid-19 patient with acute respiratory infectious symptoms and severe lung involvement (Inclusion criteria) Covid-19 patient with mild respiratory infectious symptoms and mild lung involvement (Exclusion criteria)
Intervention groups
Intervention group: Receiving MSCc along with common treatment Control group : Receiving common treatment
Main outcome variables
Respiratory status and pulmonary disease in patients,Measurement of inflammatory cytokine levels,Cell population and markers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160809029275N1
Registration date: 2020-05-30, 1399/03/10
Registration timing: prospective

Last update: 2020-05-30, 1399/03/10
Update count: 0
Registration date
2020-05-30, 1399/03/10
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51376276015
Email address
tavakolaj@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-06-14, 1399/03/25
Expected recruitment end date
2020-10-16, 1399/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evolution of Allogenic Mesenchymal stem cell- derived Umbilical cord transplantation for ARDS patients infected with COVID19.
Public title
stem cell therapy in Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Covid-19 patient with acute respirstory infectious symptoms and severe lung involvement Pulmonary compliance more than 40 Age category 18-70 years PI02/FIo2 between 100 - 300
Exclusion criteria:
Covid-19 patient with Sepsis Pregnancy The presence of malignancy or other underlying diseases Patient with age conditions outside the range of 18-70 years
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. Eligible patients randomly and without considering a specific factor are divided into two groups: intervention and control.In this method, the random number table is used .So that people with individual codes are allocated in a group and people with couple codes are allocated in the other group.This method of randomization is performed to remove bias.
Blinding (investigator's opinion)
Double blinded
Blinding description
No information will be provided to clinical caregivers and evaluators about which group got the cell and which one has not taken a cell.This method of blinding is performed to remove bias.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Regional Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave, Qoreishi Building,Vice chancellor for research and technology
City
Mashhad
Province
Razavi Khorasan
Postal code
913881394
Approval date
2020-04-23, 1399/02/04
Ethics committee reference number
IR.MUMS.REC.1399.150

Health conditions studied

1

Description of health condition studied
Covid-19 disease
ICD-10 code
RA01.0
ICD-10 code description
Severe Acute Respiratory Syndrome coronavirus

Primary outcomes

1

Description
Respiratory symptoms and pulmonary function in patients
Timepoint
In onset of study and days 2, 7 and 14 after the second injection
Method of measurement
Using CT scan image , physical examination , Oxygen saturation Percentage

2

Description
Evaluation of IFN-γ,IL4,TGF-β,IL1-β , IL-6 and TNF-a cytokine levels in patients blood
Timepoint
In onset of study and days 2, 7 and 14 after the second injection
Method of measurement
Using Elisa kits

3

Description
Cell markers and populations
Timepoint
In onset of study and days 2, 7 and 14 after the second injection
Method of measurement
Using Flow cytometery technique

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group receiving mesenchymal stem cells. In this group, patients in 3 times (1, 3 and 6 days) are received 1 million Umbilical core-derived MSCc/BW by intravenous injection ( Through the catheter and the Central vein and from the superior vena cava vein ). Also, in addition to cell therapy,Other common treatments will be given to patients according to the physician's supervision.Mesenchymal Stem cells had an ISCT standard and were given from a healthy donor. Blood samples were given from patients on days 0, 2, and 7, as well as 14 days after the second injection and patients will follow for 20 days (in terms of clinical and immunological parameters).It should be noted that of all patients at the beginning of the study conscious consent form will be received.
Category
Treatment - Surgery

2

Description
Control group: Receiving common therapies (without stem cell). In this group, patients are received other common treatments including antiviral drugs and etc In accordance with the physician's opinion and do not receive stem cells.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Dr.Mahnaz Amini
Street address
Dr.Shariati square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Quaem.Medical.center@mums.ac.ir
Web page address
http://nobatdrazavi.tamin.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Daneshgah Ave, Qoreishi Building,Vice chancellor for research and technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresearch@mums.ac.ir
Grant name
Grant provided for COVID 19 projects
Grant code / Reference number
981880
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
70
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

2

Sponsor
Name of organization / entity
Parnia stem cell Knowledge-based company
Full name of responsible person
Seyed jalil tavakol afshari
Street address
Kafai 1, Sadra Medical Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773113
Phone
+98 51 3848 2194
Fax
+98 51 3848 2194
Email
Parnia@mums.ir
Web page address
Grant name
Parnia-COVID19
Grant code / Reference number
پرنیا 19
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Parnia stem cell Knowledge-based company
Proportion provided by this source
30
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyad Jalil Tavakol Afshari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Stem cell therapy
Street address
Bu-Ali square, Bu-Ali Science and Technology Park
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3711 2610
Fax
+98 51 3711 2596
Email
Tavakolaj@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyad Jalil Tavakol Afshari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Bu-Ali square, Bu-Ali Science and Technology Park
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3711 2610
Fax
+98 51 3711 2611
Email
Tavakolaj@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyad Jalil Tavakol Afshari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Bu-Ali square. Bu-Ali Science and Technology Park
City
Mashhad
Province
Razavi Khorasan
Postal code
9196773117
Phone
+98 51 3711 2610
Fax
+98 51 3711 2611
Email
Tavakolaj@mums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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