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Cell therapy in patients with coronavirus19 using mesenchymal stem cells

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History
# Registration date Revision Id
3 2020-09-13, 1399/06/23 150788
2 2020-09-02, 1399/06/12 149970
1 2020-04-22, 1399/02/03 130744
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  • Protocol summary

    one group with 10 uncontrolled patients, Phase I clinical trial
    one group with 5 uncontrolled patients, Phase I clinical trial
    یک گروه با 10 بیمار بدون کنترل ، کارازمایی بالینی فاز یک
    یک گروه با 5 بیمار بدون کنترل ، کارازمایی بالینی فاز یک
    Mesenchymal stem cells about 1/106 MSC / Kg by intravenous injection twice in a patient
    Mesenchymal stem cells about 2*106(based on IBW) MSC / Kg by intravenous injection three times in a patient
    سلول های بنیادی مزانشیمی در حدود MSC/Kg 1×106 به صورت تزریق وریدی دوبار تزریق در یک بیمار
    سلول های بنیادی مزانشیمی در حدود MSC/Kg 2×106 (براساس IBW)به صورت تزریق وریدی سه بار تزریق در یک بیمار

  • General information

    empty
    65
    empty
    Year
    Yes
    No
    10
    5
    2020-07-20, 1399/04/30
    2020-10-21, 1399/07/30
    empty
    Changes in initial outcomes, age limit, number of patients, and number of injections
    empty
    تغییراتی در پیامد های اولیه،محدودیت سنی، تعداد بیمار و تعداد تزریق

  • Primary outcomes

    #1
    28 days
    28 days-From the time of cell injection until the 28th day
    28 روز
    28 روز -از زمان تزریق سلول تا روز 28م
    #2
    partial arterial oxygen pressure (PaO2)
    O2 saturation
    فشار اکسیژن شریانی نسبی (PaO2)
    درصد اشباع اکسیژن
    14 days
    0,3,6days.Since the injection of the cell
    14 روز
    0,3,6. از زمان تزریق سلول
    #3
    oxygen concentration (FiO2)
    inflammation cytokines. Il-6 & Il-10
    غلظت اکسیژن (FiO2)
    سایتوکاین التهابی. اینترلوکین 6 و 10
    14 days
    0,3,6,14 days-Since the injection of the cell
    14 روز
    0,3,6,14 روز-اززمان تزریق سلول
    ventilator
    Assay by the Elisa
    ونتیلاتور
    سنجش توسط الایزا

  • Intervention groups

    #1
    Intervention group: Patients with COVID19 who are transplanted with mesenchymal stem cells that are injected 1–1.5 x 106 Via (IV) intravenous injection.
    Intervention group: Patients with COVID19 who are transplanted with mesenchymal stem cells that are injected 2x 106 (based on IBW) Via (IV) intravenous injection.
    گروه مداخله: بیماران مبتلا به کرونا ویروس 19 که مورد پیوند سلول های بنیادی مزانشیمی قرار می گیرند که به میزان یک میلیون تا یک و نیم میلیون در هر کیلوگرم وزن بدن از طریق خون محیطی تزریق می شود.
    گروه مداخله: بیماران مبتلا به کرونا ویروس 19 که مورد پیوند سلول های بنیادی مزانشیمی قرار می گیرند که به میزان per kilogram 2 x 106 cells(براساس IBW) از طریق خون محیطی تزریق می شود.

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Barakat Pharmaceutical Group
    Name of organization / entity - Persian: شرکت گروه دارویی برکت
    Full name of responsible person - English: Dr. Akbar Borandegi
    Full name of responsible person - Persian: دکتر اکبر برندگی
    Street address - English: No. 11, 5th Alley, Bucharest Ave., Argentina Sq, Tehran, Iran
    Street address - Persian: تماس با ما تهران - خیابان شهید بهشتی خیابان احمد قصیر خیابان پنجم پ11
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: .......
    Phone: +98 21 8848 0156
    Fax:
    Email: info@bpharmed.com
    Web page address: http://www.bpharmed.com
    contact.organization_id:
    Name of organization / entity - English: Barakat Pharmaceutical Group
    Name of organization / entity - Persian: شرکت گروه دارویی برکت
    Full name of responsible person - English: Dr. Akbar Borandegi
    Full name of responsible person - Persian: دکتر اکبر برندگی
    Street address - English: No. 11, 5th Alley, Bucharest Ave., Argentina Sq, Tehran, Iran
    Street address - Persian: تهران - خیابان بخارست، میدان آرژانتین، خیابان پنجم پلاک11
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: .......
    Phone: +98 21 8848 0156
    Fax:
    Email: info@bpharmed.com
    Web page address: http://www.bpharmed.com

Protocol summary

Study aim
Determination of Safety and Feasibility of Cell Therapy Using Mesenchymal stem Cells in Improving Patients with COVID19
Design
one group with 5 uncontrolled patients, Phase I clinical trial
Settings and conduct
Intravenous injection of mesenchymal stem cells in Shariati hospital in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Continuous hypoxemia, Respiratory failure requiring a Ventilator, Chest has multilobar infiltrates, Shock, Organ failure; Exclusion criteria: Patient dissatisfaction, Pregnant patient, Age less than 17 years, Patient with known active malignancy
Intervention groups
Mesenchymal stem cells about 2*106(based on IBW) MSC / Kg by intravenous injection three times in a patient
Main outcome variables
Evaluation of Survival rate patients after injection. Laboratory Tests: Tests, Cell blood count albumin, ESR, D-dimer, LDH, CRP and

General information

Reason for update
Changes in initial outcomes, age limit, number of patients, and number of injections
Acronym
IRCT registration information
IRCT registration number: IRCT20190717044241N2
Registration date: 2020-04-22, 1399/02/03
Registration timing: registered_while_recruiting

Last update: 2020-09-07, 1399/06/17
Update count: 2
Registration date
2020-04-22, 1399/02/03
Registrant information
Name
Mahshid Saleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7736 5353
Email address
mahshid_saleh@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cell therapy in patients with coronavirus19 using mesenchymal stem cells
Public title
Cell therapy in patients with coronavirus19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Persistent hypoxemia despite receiving less than 93% Saturation oxygen Respiratory failure requires a Ventilator Chest has multilobar infiltrates Shock Organ failure
Exclusion criteria:
Patient dissatisfaction Pregnant patient Age less than 17 years Patient with known active malignancy
Age
From 17 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 5
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
Iran National committee for Ethics in Biomedical research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
.....
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.TUMS.VCR.REC.1399.203

Health conditions studied

1

Description of health condition studied
COVID19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Clinical response
Timepoint
28 days-From the time of cell injection until the 28th day
Method of measurement
clinical observation by Infectious Diseases Specialist

2

Description
O2 saturation
Timepoint
0,3,6days.Since the injection of the cell
Method of measurement
ventilator

3

Description
inflammation cytokines. Il-6 & Il-10
Timepoint
0,3,6,14 days-Since the injection of the cell
Method of measurement
Assay by the Elisa

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients with COVID19 who are transplanted with mesenchymal stem cells that are injected 2x 106 (based on IBW) Via (IV) intravenous injection.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr Neda Alijani
Street address
Tehran Province, Tehran, District 6, Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Barakat Pharmaceutical Group
Full name of responsible person
Dr. Akbar Borandegi
Street address
No. 11, 5th Alley, Bucharest Ave., Argentina Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
.......
Phone
+98 21 8848 0156
Email
info@bpharmed.com
Web page address
http://www.bpharmed.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barakat Pharmaceutical Group
Proportion provided by this source
80
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

2

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Deputy of Research and Technology, sixth floor, Central University Organization, corner of St. Quds, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
20
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
Tehran University of Medical Sciences
Full name of responsible person
Mahshid Saleh
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Applied cell sciences
Street address
No. 88, Italy St, Eastern side of Tehran University، Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
55469-14177
Phone
+98 21 4305 2000
Email
Mahshid_saleh@ymail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Javad Verdi- Dr Neda Alijani
Position
دانشیار
Latest degree
Specialist
Other areas of specialty/work
Cell Therapy
Street address
No. 88, Italy St, Eastern side of Tehran University، Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
55469-14177
Phone
+98 21 4305 2000
Email
javadverdi2019@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahshid Saleh
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Cell Therapy
Street address
Tehran Province, Tehran, Eastern side of Tehran University، Italy St, No. 88
City
Tehran
Province
Tehran
Postal code
55469-14177
Phone
+98 21 4305 2000
Email
Mahshid_saleh@ymail.com

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
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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