View older revisions Content changed at 2021-01-02, 1399/10/13

Protocol summary

Study aim
Evaluation of safety and efficacy of mesenchymal stem cells in patients with COVID19
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 20 patients. Software was used for randomization.
Settings and conduct
Stem cell injection to patients with acute pulmonary insufficiency with COVID19 (these cells are approximately 2x 106 cells per kilogram (based on IBW) will be injected IV through the patient 3 times at 3-day intervals (0, 3, 6). ) Shariati Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria 1- Age more than 18 years and less than 65 years 2- Clinical symptoms, including: 30≤ PR, SO2≤ 93% at rest or persistent hypoxia 3- Respiratory failure requires a ventilator 4- Chest x-ray: in Chest have multilobar infiltrates% <50 Exclusion criteria 1. Patient dissatisfaction 2. Pregnant patient 3. Age under 18 years and over 65 years 4. Patient with known active malignancy 5. Septic shock 6. Organ failure 7. Enter another study
Intervention groups
Treatment Group: Patients with coronavirus 19 who are transplanted with mesenchymal stem cells at a rate of two million per kilogram of body weight (based on IBW) through peripheral blood on days 0, 3, and 6. Control group: Participants receive routine treatment and placebo (based on IBW) intravenously on days 0, 3, and 6.
Main outcome variables
Clinical response; O2 saturation; inflammation cytokines. Il-6 & Il-10

General information

Reason for update
Request to change the phone number in the Registrant information section to 989127249532
Acronym
IRCT registration information
IRCT registration number: IRCT20190717044241N3
Registration date: 2020-12-31, 1399/10/11
Registration timing: registered_while_recruiting

Last update: 2021-01-02, 1399/10/13
Update count: 1
Registration date
2020-12-31, 1399/10/11
Registrant information
Name
Mahshid saleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7736 8490
Email address
mahshid_saleh@ymail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cell therapy in patients with COVID-19 using mesenchymal stem cells: Phase 2 clinical trial
Public title
Cell therapy in patients with COVID-19
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
Exclusion criteria:
Patient dissatisfaction Pregnant patient Age under 18 years and over 65 years Patient with known active malignancy Shock Organ failure
Age
From 17 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was used for achieving equal sample sizes in each group. For example, in intervention (I)/control (C) comparison, the process involved recruiting participants in short blocks and ensuring that half of the participants within each block were allocated to the ‘‘I’’ group and the other half to the ‘‘C’’ group. Within each block, however, the order of patients was random. We considered size 4 blocks. If I/C is represented by I/C methods, there would be 6 different ways in which 4 patients can be split evenly between 2 methods.
Blinding (investigator's opinion)
Double blinded
Blinding description
There are the same cell bags for infusion during the study. Cleanroom staff, DSMB, and data statisticians just aware of their contents.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته ملی اخلاق در پژوهش‌های زیست پزشکی
Street address
تهران- شهرک قدس (غرب)- بین فلامک جنوبی و زرافشان، خیابان سیمای ایران- ستاد مرکزی وزارت بهداشت، درمان وآموزش پزشکی، بلوک A، طبقه سیزدهم
City
Tehran
Province
Tehran
Postal code
.....
Approval date
2020-12-01, 1399/09/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.823

Health conditions studied

1

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

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
Since the injection of the cell; 0,3,6 days.
Method of measurement
ventilator

Secondary outcomes

1

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

2

Description
CD4 and CD8 markers
Timepoint
On days 0,3,6,14 - from the time of cell injection
Method of measurement
Flow Cytometry

3

Description
Evaluation of lung function
Timepoint
On days 0,14 - from the time of cell injection
Method of measurement
CT scan of the lungs

Intervention groups

1

Description
Intervention group: Patients with coronavirus 19 who undergo mesenchymal stem cell transplantation at a rate of 2 million per kilogram body weight (based on IBW) through peripheral blood (IV)on days 0, 3, and 6.
Category
Treatment - Other

2

Description
Control group: Participants with COVID19 receiving routine and placebo treatment (based on IBW) intravenously on days 0, 3, and 6.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان شریعتی
Full name of responsible person
دکتر ندا علیجانی
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?
No
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?
No
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 - Dr Iman seyhoun
Position
Ph.D. student- Ph.D
Latest degree
Ph.D.
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; 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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