Protocol summary

Study aim
Evaluation of the adipose and placenta-derived mesenchymal stem cells effect on the respiratory distress syndrome in patients with COVID-19 (a pilot study)
Design
Clinical trials have two groups, the first group receiving three stem cells with common treatment and the control group receiving only the most common treatment, with parallel groups, single blind, phase one on six patients.
Settings and conduct
The place of study is infectious diseases department of Imam Reza Hospital in Kermanshah. Blinding process: the study will be double-blind in which participants and analyzer will be kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: COVID-19 patient; acute respiratory infectious and distress symptoms; Inclusion criterion: COVID-19 patient with mild respiratory infection and mild lung involvement
Intervention groups
Intervention group: patients are treated with Mesenchymal cells in addition to common treatment protocol. Control group: they just receive the common treatment.
Main outcome variables
Biomarker on cells; respiratory symptoms and lung function in patients; Il-6 and Il-1 in patient blood

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200418047121N2
Registration date: 2020-05-05, 1399/02/16
Registration timing: prospective

Last update: 2020-05-05, 1399/02/16
Update count: 0
Registration date
2020-05-05, 1399/02/16
Registrant information
Name
KAMRAN MANSOURI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6473
Email address
kmansouri@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the adipose and placenta-derived mesenchymal stem cells effect on the respiratory distress syndrome in patients with COVID-19: a pilot study
Public title
Stem cell therapy in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with COVID19 Acute respiratory infectious symptoms and severe lung involvement
Exclusion criteria:
Patients with mild symptoms and mild lung involvement
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 6
More than 1 sample in each individual
Number of samples in each individual: 1
6 Patients with COVID19 are selected with acute respiratory infectious symptoms and severe lung involvement (at the discretion of the medical team)
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
No information will be given to clinical evaluators and participants as to which group received the cells and which group did not
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Medical Biology Research Center; Parstar blvd; Roodaki
City
Kermanshah
Province
Kermanshah
Postal code
67417
Approval date
2020-04-14, 1399/01/26
Ethics committee reference number
IR.KUMS.REC.1399.065

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
biomarker expression
Timepoint
two weeks after last cell therapy
Method of measurement
Flowcytometery

2

Description
IL-6 and IL-1 Level
Timepoint
Before Cell injection and two weeks after cell injection
Method of measurement
Elisa Kit

3

Description
Respiratory and lung function
Timepoint
Before Cell injection and two weeks after cell injection
Method of measurement
Physical examination , O2 saturation and CT Scan

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Three Patients suffering from COVID-19 with acute respiratory infections and severe lung involvement will be allocated to this group under the supervision of the medical staff. Those patients with severe symptoms (pneumonia and ARDS) will be suggested to join this pilot study and after obtaining the written informed consent, they participate in this investigation at Emam Reza hospital (at transplantation ward). Afterward, 1 × 106 cells/Kg of weight are prepared for transplantation in addition to common treatment protocol. Cell transplantation is repeated once every 3-4 days during a 14-day period (totally three doses). After cell transplantation, patients are assessed for two weeks, all the symptoms and side effects such as allergic reactions and secondary infections also the level of the cytokines variation, the level of CRP and the oxygen saturation, lymphocyte count, the chest CT and the respiratory rate will be assessed and compared with control group.
Category
Treatment - Drugs

2

Description
Control group: just receive the common treatment. Patients are assessed for two weeks, all the clinical symptoms such as the level of the cytokines, the level of CRP and the oxygen saturation, lymphocyte count, the chest CT and the respiratory rate are examined.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bostan hospital
Full name of responsible person
Kamran Mansouri
Street address
Medical Biology Research Center; Parstar blvd; Roodaki
City
Kermanshah
Province
Kermanshah
Postal code
6714755815
Phone
+98 83 3427 6473
Fax
+98 83 3427 6471
Email
kamranmansouri@gmail.com
Web page address
http://mbrc.ac.ir/en/index.aspx

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti boulevard
City
Kermanshah
Province
Kermanshah
Postal code
67417
Phone
+98 83 3837 0541
Fax
+98 83 3837 0541
Email
fnajafi@kums.ac.ir
Web page address
https://vc-research.kums.ac.ir/en/home
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Charity Association of Kermanshah University of Medical Sciences
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kamran Mansouri
Position
Assitance professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Medical Biology Research Center; Parstar blvd; Roodaki
City
Kermanshah
Province
Kermanshah
Postal code
6714755817
Phone
+98 83 3427 6473
Fax
+98 83 3427 6471
Email
kamranmansouri@gmail.com
Web page address
http://mbrc.ac.ir/en/index.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kamran Mansouri
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Medical Biology Research Center; Parstar blvd; Roodaki
City
Kermanshah
Province
Kermanshah
Postal code
67147
Phone
+98 83 3427 6473
Fax
+98 83 3427 6471
Email
kamranmansouri@gmail.com
Web page address
http://mbrc.ac.ir/en/index.aspx

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
kamran mansouri
Position
assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Medical Biology Research Center; Parstar blvd; Roodaki
City
Kermanshah
Province
Kermanshah
Postal code
67147
Phone
+98 83 3427 6473
Fax
+98 83 3427 6471
Email
kamrnamnasouri@gmail.com
Web page address
http://mbrc.ac.ir/en/index.aspx

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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