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Protocol summary
The intervention group (n=6) will receive three doses of MSCs. Three doses of 200×10e6± (10%) cells will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0, day 2, day 4. The cells will inject in 50 ml saline containing 1% human serum albumin.
The intervention group (n=11) will receive three doses of MSCs. Three doses of 200×10e6± (10%) cells will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0, day 2, day 4. The cells will inject in 50 ml saline containing 1% human serum albumin.
The intervention group (n=611) will receive three doses of MSCs. Three doses of 200×10e6± (10%) cells will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0, day 2, day 4. The cells will inject in 50 ml saline containing 1% human serum albumin.
گروه مداخله (6 بیمار). بیماران سه دوز سلول بنیادی مزانشیم دریافت می کنند. این سه دوز سلولی شامل (10%) ±200 میلیون سلول است که در 50 میلی لیتر محلول نمک حاوی 1٪ آلبومین سرم انسانی، به صورت داخل وریدی در طی 10-12 دقیقه، با سرعت تزریق 4-5 میلی لیتر در دقیقه، در روز 0 ، روز 2 ، روز 4 تزریق می شود.
گروه مداخله (11 بیمار). بیماران سه دوز سلول بنیادی مزانشیم دریافت می کنند. این سه دوز سلولی شامل (10%) ±200 میلیون سلول است که در 50 میلی لیتر محلول نمک حاوی 1٪ آلبومین سرم انسانی، به صورت داخل وریدی در طی 10-12 دقیقه، با سرعت تزریق 4-5 میلی لیتر در دقیقه، در روز 0 ، روز 2 ، روز 4 تزریق می شود.
گروه مداخله (611 بیمار). بیماران سه دوز سلول بنیادی مزانشیم دریافت می کنند. این سه دوز سلولی شامل (10%) ±200 میلیون سلول است که در 50 میلی لیتر محلول نمک حاوی 1٪ آلبومین سرم انسانی، به صورت داخل وریدی در طی 10-12 دقیقه، با سرعت تزریق 4-5 میلی لیتر در دقیقه، در روز 0 ، روز 2 ، روز 4 تزریق می شود.
General information
6
11
611
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The number of patients has increased.
The number of patients has increased.
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تعداد بیماران افزایش یافته است.
تعداد بیماران افزایش یافته است.
Recruitment centers
#1
Name of recruitment center - English: Masih Daneshvari Hospital
Name of recruitment center - Persian: بیمارستان مسیح دانشوری
Full name of responsible person - English: محمد رضا هاشمیان
Full name of responsible person - Persian: Mohammad Reza Hashemian
Street address - English: Masih Daneshvari Hospital., Darabad Avenue., Shahid Bahonar Avenue
Street address - Persian: خيابان شهيد باهنر (نياوران)، دارآباد، بیمارستان مسیح دانشوری
City - English: تهران
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1956944413
Phone: +98 21 2610 5050
Fax:
Email: smrhashemian@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Masih Daneshvari Hospital
Name of recruitment center - Persian: بیمارستان مسیح دانشوری
Full name of responsible person - English: Mohammad Reza Hashemian
Full name of responsible person - Persian: محمد رضا هاشمیان
Street address - English: Masih Daneshvari Hospital., Darabad Avenue., Shahid Bahonar Avenue
Street address - Persian: خيابان شهيد باهنر (نياوران)، دارآباد، بیمارستان مسیح دانشوری
City - English: تهران
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1956944413
Phone: +98 21 2610 5050
Fax:
Email: smrhashemian@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Masih Daneshvari Hospital Name of recruitment center - Persian: بیمارستان مسیح دانشوری Full name of responsible person - English: محمد رضا هاشمیانMohammad Reza Hashemian Full name of responsible person - Persian: Mohammad Reza Hashemianمحمد رضا هاشمیان Street address - English: Masih Daneshvari Hospital., Darabad Avenue., Shahid Bahonar Avenue Street address - Persian: خيابان شهيد باهنر (نياوران)، دارآباد، بیمارستان مسیح دانشوری City - English: تهران City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1956944413 Phone: +98 21 2610 5050 Fax: Email: smrhashemian@sbmu.ac.ir Web page address:
Protocol summary
Study aim
The main objective is to investigate the safety of cell therapy in patients with ARDS caused by Coronavirus pneumonia
Design
A Phase 1 and 2, non-controlled non-randomized clinical trial
Settings and conduct
The study will be conducted at Masih Daneshvari Hospital and Shariati Hospital.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 65 years are included in the study with a definitive diagnosis of COVID-19, which subsequently develops acute respiratory distress syndrome.
COVID-19 patients with severe underlying disease or allergies to the cell or its associated compounds are not included in the study.
Intervention groups
The intervention group (n=11) will receive three doses of MSCs. Three doses of 200×10e6± (10%) cells will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0, day 2, day 4. The cells will inject in 50 ml saline containing 1% human serum albumin.
Main outcome variables
Side effects; oxygen saturation level; Improvement of clinical symptoms (fever, cough).
General information
Reason for update
The number of patients has increased.
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046526N1
Registration date:2020-04-13, 1399/01/25
Registration timing:retrospective
Last update:2020-05-31, 1399/03/11
Update count:2
Registration date
2020-04-13, 1399/01/25
Registrant information
Name
Masoumeh Nouri
Name of organization / entity
Royan Stem Cell Technology Co
Country
Iran (Islamic Republic of)
Phone
+98 21 2763 5512
Email address
m.nouri@rsct.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-15, 1398/12/25
Expected recruitment end date
2020-03-25, 1399/01/06
Actual recruitment start date
2020-03-15, 1398/12/25
Actual recruitment end date
2020-03-25, 1399/01/06
Trial completion date
2020-04-25, 1399/02/06
Scientific title
Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection : A Phase 1 and 2 clinical trial
Public title
Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of 2019-nCoV infection by RT-PCR
Diagnosis of ARDS according to the Berlin definition of ARDS
Requiring supplemental oxygen, OR Pneumonia that is judged by chest radiograph or CT
PaO2/oxygen absorption concentration (FiO2) ≤ 300MMHG
Pulmonary imaging shows that the focused progress > 50% in 24-48 hours
Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU <48 hours
SOFA score between 2-3 point
Exclusion criteria:
Severe allergies or allergies after 1st injection to stem cell preparations and their components
Patients with a malignant tumor, other serious systemic diseases, and psychosis
Co-Infection of HIV, tuberculosis, influenza virus, adenovirus, and another respiratory infection virus
Patients with previous history of pulmonary embolism
Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections)
Liver or kidney SOFA score of more than 3 points; combined with other organ failures (need organ support), Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30)
Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia
Continuous use of immunosuppressive agents or organ transplants in the past 6 months
In vitro life support (ECMO, ECCO2R, RRT)
Pregnant or lactating women
Uncontrolled underling disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
6
Actual sample size reached:
11
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
Ethic committee of National Institute for Medical Research Development
Street address
No 21, Besat Street., Western Fatimid Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2020-03-12, 1398/12/22
Ethics committee reference number
IR.NIMAD.REC.1398.412
Health conditions studied
1
Description of health condition studied
Acute Respiratory Distress Syndrome of COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Adverse events assesment
Timepoint
At the same time of each intervention, 24 hours after each intervention, on days 6, 7, 14 and 28 after the first intervention
Method of measurement
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcomes
1
Description
Blood oxygen saturation
Timepoint
At Baseline, simultaneously with each intervention and on days 5, 6, 7, 14 after the first intervention
Method of measurement
Evaluation of Pneumonia Improvement
Intervention groups
1
Description
Intervention group: (n=6). Patients will receive three doses of MSCs. Three doses of 200×10e6 (±10%) cells will intravenously infuse as a normally dropped single dose over 10-12 minutes at the infusion speed of 4-5 mL/minute in day 0, day 2, day 4. The cells will inject in 50 ml saline containing 1% human serum albumin.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Mohammad Reza Hashemian
Street address
Masih Daneshvari Hospital., Darabad Avenue., Shahid Bahonar Avenue
City
تهران
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
smrhashemian@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Rasoul Alian Nejad
Street address
Shariati Hospital., Jalal-e-Al-e-Ahmad Hwy
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
Iranian academic center for education culture and research
Full name of responsible person
Abdol Hossein Shahverdi
Street address
No. 2, Hafez St., Banihashem St., Resalat Ave
City
تهران
Province
Tehran
Postal code
16635148
Phone
+98 21 2233 9940
Email
shahverdi@royaninstitute.org
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
90
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
National Institute for Medical Research Development
Full name of responsible person
Reza Mlekzadeh
Street address
No 21, Besat Street., Western Fatimid Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Phone
+98 21 6693 8037
Email
dr.reza.malekzadeh@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development