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Recruitment centers
#1
Name of recruitment center - English: Esfahan Shahid sadoughi Hospital
Name of recruitment center - Persian: بیمارستان شهید صدوقی
Full name of responsible person - English: Mojtaba Javani - Hossein Shafee
Full name of responsible person - Persian: مجتبی جوانی- حسین شفیعی
Street address - English: Bozorgmehr st.,
Street address - Persian: خ بزرگمهر
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 1287947786
Phone: +98 31 3664 5476
Fax:
Email: Shariatihosp@tums.ac.ir
Web page address:
Name of recruitment center - English: Esfahan Shahid sadoughi Hospital
Name of recruitment center - Persian: بیمارستان شهید صدوقی
Full name of responsible person - English: Mojtaba Javani; Hossein Shafee
Full name of responsible person - Persian: مجتبی جوانی- حسین شفیعی
Street address - English: Bozorgmehr st.,
Street address - Persian: خ بزرگمهر
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 1287947786
Phone: +98 31 3664 5476
Fax:
Email: Shariatihosp@tums.ac.ir
Web page address:
Name of recruitment center - English: Esfahan Shahid sadoughi Hospital Name of recruitment center - Persian: بیمارستان شهید صدوقی Full name of responsible person - English: Mojtaba Javani -; Hossein Shafee Full name of responsible person - Persian: مجتبی جوانی- حسین شفیعی Street address - English: Bozorgmehr st., Street address - Persian: خ بزرگمهر City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 1287947786 Phone: +98 31 3664 5476 Fax: Email: Shariatihosp@tums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Omid Cell and Tissue center
Name of organization / entity - Persian: شرکت فراوری سلول و بافت امید
Full name of responsible person - English: Masoud Soleimani
Full name of responsible person - Persian: مسعود سلیمانی
Street address - English: Kargar St,. Shokrollah St, No.131
Street address - Persian: کارگر شمالی- شکراله- شماره ۱۳۱
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411913661
Phone: +98 21 8288 4508
Fax:
Email: soleimani.masoud@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Omid Cell and Tissue center
Name of organization / entity - Persian: شرکت فراوری سلول و بافت امید
Full name of responsible person - English: Masoud Soleimani
Full name of responsible person - Persian: مسعود سلیمانی
Street address - English: No.131, Shokrollah St, Kargar St
Street address - Persian: کارگر شمالی- شکراله- شماره ۱۳۱
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411913661
Phone: +98 21 8288 4508
Fax:
Email: soleimani.masoud@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Omid Cell and Tissue center Name of organization / entity - Persian: شرکت فراوری سلول و بافت امید Full name of responsible person - English: Masoud Soleimani Full name of responsible person - Persian: مسعود سلیمانی Street address - English: Kargar StNo.131,. Shokrollah St, No.131Kargar St Street address - Persian: کارگر شمالی- شکراله- شماره ۱۳۱ City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411913661 Phone: +98 21 8288 4508 Fax: Email: soleimani.masoud@gmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University
Name of organization / entity - Persian: دانشگاه تربیت مدرس
Full name of responsible person - English: Masoud Soleimani
Full name of responsible person - Persian: مسعود سلیمانی
Position - English: Professor
Position - Persian: استاد
Latest degree: phd
Area of specialty/work: 39
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hematology and cell therapy Department., Faculty of Medical Sciences, Tarbiat Modares University
Street address - Persian: دانشگاه تربیت مدرس ُ دانشکده علوم پزشکی ُ گروه هماتولوژی و سلول درمانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 141533121
Phone: +98 21 8288 4508
Mobile: +98 930 911 6174
Fax: +98 21 8288 4508
Email: soleimani.masoud@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University
Name of organization / entity - Persian: دانشگاه تربیت مدرس
Full name of responsible person - English: Mina Soufizomorrod
Full name of responsible person - Persian: مینا صوفی زمرد
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 39
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hematology and cell therapy Department., Faculty of Medical Sciences, Tarbiat Modares University
Street address - Persian: دانشگاه تربیت مدرس ُ دانشکده علوم پزشکی ُ گروه هماتولوژی و سلول درمانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 141533121
Phone: +98 21 8288 4508
Mobile: +98 930 911 6174
Fax: +98 21 8288 4508
Email: soleimani.masoud@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Tarbiat Modares University Name of organization / entity - Persian: دانشگاه تربیت مدرس Full name of responsible person - English: Masoud SoleimaniMina Soufizomorrod Full name of responsible person - Persian: مسعود سلیمانیمینا صوفی زمرد Position - English: Assistant Professor Position - Persian: استاداستادیار Latest degree: phd Area of specialty/work: 39 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Hematology and cell therapy Department., Faculty of Medical Sciences, Tarbiat Modares University Street address - Persian: دانشگاه تربیت مدرس ُ دانشکده علوم پزشکی ُ گروه هماتولوژی و سلول درمانی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 141533121 Phone: +98 21 8288 4508 Mobile: +98 930 911 6174 Fax: +98 21 8288 4508 Email: soleimani.masoud@gmail.com Web page address:
Protocol summary
Study aim
The main objective is to investigate the safety and efficacy of Exosomes therapy in patients with ARDS caused by Coronavirus pneumonia as an open-labeled randomized clinical trial.
Design
Controlled randomized clinical trial phase 1-2
Settings and conduct
The study will be conducted at Nikan Hospital , Shariati Hospital, Esfahan Shahid Sadoughi Hospital, Yazd Shahid Sadoughi Hospital. Participants, outcome assessors, and analyzers are unaware of the allocation of study groups.
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 (mild or moderate). COVID-19 patients with severe underlying disease or allergies to the ٍExosomes or its associated compounds are not included in the study.
Intervention groups
Patients allocated randomly to two groups: 1) Intervention 1, Patients will receive Six doses of Exosomes. 2) Control, Patients will receive conventional therapy.
Main outcome variables
Safety; Blood oxygen saturation; Decreased severity of pneumonia; Improvement of the acute respiratory syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200413047063N2
Registration date:2021-04-14, 1400/01/25
Registration timing:registered_while_recruiting
Last update:2021-07-08, 1400/04/17
Update count:1
Registration date
2021-04-14, 1400/01/25
Registrant information
Name
Masoud Soleimani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4508
Email address
soleimani.masoud@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exosomes Derived from placental Mesenchymal Stem Cells as Treatment for Severe COVID-19: Phase 1 & 2 Clinical Trials
Public title
Exosomes Derived from placental Mesenchymal Stem Cells as Treatment for Severe COVID-19: Phase 1 & 2 Clinical Trials
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, 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 Pneumonia that is judged by chest radiograph or CT
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 other respiratory infection virus Patients with previous history of pulmonary embolism Liver or kidney SOFA score of more than 3 points; combined with other organ failure (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 underlying disease Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections)
Age
From 18 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly divided into two equal groups using a randomized double AB blocking method based on a random number table.
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
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2020-09-19, 1399/06/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.454
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, 12 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
Biomarkers concentrations in plasma
Timepoint
At baseline, 7, 14, 28 days after the first intervention
Method of measurement
Biochemical examination
2
Description
Respiratory efficacy
Timepoint
From baseline to day 7
Method of measurement
Evaluated by the increase in PaO2/FiO2 ratio
3
Description
Intensive care unit-free days
Timepoint
Up to day 8
Method of measurement
Number of day
4
Description
Change in clinical symptoms
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:Intervention group: The intervention group 1, Patients will receive Six doses of Exosomes. One doses of 10×10e10 (±10%) Exosomes 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 and day 1 and day 2. group:
Category
Treatment - Other
2
Description
Control group: Patients will receive conventional therapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Mohammad Aliannaejad
Street address
Jalal al Ahmad st.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
Shariatihosp@tums.ac.ir
2
Recruitment center
Name of recruitment center
WestNikan Hospital
Full name of responsible person
Mohamad Soroush
Street address
Shahid Hemat Highway
City
Tehran
Province
Tehran
Postal code
1411913667
Phone
+98 21 4756 4756
Email
info@westnikanhospital.com
3
Recruitment center
Name of recruitment center
Esfahan Shahid sadoughi Hospital
Full name of responsible person
Mojtaba Javani; Hossein Shafee
Street address
Bozorgmehr st.,
City
Isfahan
Province
Isfehan
Postal code
1287947786
Phone
+98 31 3664 5476
Email
Shariatihosp@tums.ac.ir
4
Recruitment center
Name of recruitment center
Yazd Shahid Sadoughi Hospital
Full name of responsible person
Mohammad Samet
Street address
Pezeshki uni
City
Yazd
Province
Yazd
Postal code
4432707062
Phone
+98 31 5673 6227
Email
samet_mo@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Omid Cell and Tissue center
Full name of responsible person
Masoud Soleimani
Street address
No.131, Shokrollah St, Kargar St
City
Tehran
Province
Tehran
Postal code
1411913661
Phone
+98 21 8288 4508
Email
soleimani.masoud@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Omid Cell and Tissue center
Proportion provided by this source
90
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Vasei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Pathology
Street address
Jalal al Ahmad
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
mvasei@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Masoud Soleimani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Jalal al Ahmad st.
City
Tehran
Province
Tehran
Postal code
1411533121
Phone
+98 21 8288 4508
Email
Soleim_m@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mina Soufizomorrod
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Hematology and cell therapy Department., Faculty of Medical Sciences, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
141533121
Phone
+98 21 8288 4508
Fax
+98 21 8288 4508
Email
soleimani.masoud@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
All collected deidentified IPD can be shared
When the data will become available and for how long
6 months after publication
To whom data/document is available
Researchers and clinicians
Under which criteria data/document could be used
Planning of similar studies in other academic centers
From where data/document is obtainable
e-Mail
What processes are involved for a request to access data/document