Protocol summary

Summary
This study is the second phase of a RCT study that attempts to employ the stem cells isolated from the embryonic membranes as a strategy for treatment of patients with acute respiratory distress syndrome. To achieve this goal, three groups (each group includes 5 cases) suffering from acute respiratory syndrome referred to two hospitals in Tehran (Shariati and Imam Khomeini) will be selected. Inclusion criterion is patients with age >18. On the other hand, exclusion criterion would be any acute and systemic infections like HIV, Hepatitis B and C. The first, second, and third groups will intravenously receive 1000000/kg, 2000000/kg, and 5000000/kg embryonic stromal cells, respectively (each injection should take 30 minutes). Patients will be monitored by ICU specialists for possible complications immediately after injections. Indeed, the major complication in this study is expected to be the elevation in patient's doses of vasopressors (norepinephrine, phenylepinephrine, dopamine, epinephrine, etc.) Other complications are post-injection clinical instabilities especially in cardiac and respiratory systems, together with dose-limiting toxicity. It should be mentioned that no blinding will be utilized for evaluation of these complications.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010531786N1
Registration date: 2017-03-27, 1396/01/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-27, 1396/01/07
Registrant information
Name
Behnam Sadeghi
Name of organization / entity
Breast Cancer Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 88679402
Email address
bsadeghi@ibcrc.ir
Recruitment status
Recruitment complete
Funding source
Breast Cancer Research Center (BCRC) collaboration with: 1:Pasteur Institute of Iran 2:Center for AIDS Research 3: Shariati Hospital
Expected recruitment start date
2017-01-01, 1395/10/12
Expected recruitment end date
2019-01-01, 1397/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
using Human decidua stromal cells for the treatment of acute respiratory distress syndrome (ARDS), Phase 2
Public title
Isolation , Purification, Characterization and Commercialization of Stem Cells From Fetal Membrane layers and Their Use for the Treatment of Patients With Acute Respiratory Distress Syndrome (ARDS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients over 18 years of age; Diagnosis is done by Berlin definition; The disease is acute; Bilateral lungs with pulmonary edema are evident on X-ray; The patient does not have a history of heart failure; PaO02 / FiO2 less than 200 while the patient is under mechanical ventilation via endotracheal tube or tracheostomy tube with positive end-expiratory pressure at least 8 inches of water; A fungal infection does not exist. Exclusion criteria: If three days have passed from the onset of the disease; Any disease history of the vital organs such as heart disease, kidney or liver; Pregnancy; Pulmonary hypertension; Cancer; AIDS; seronegative for hepatitis A and B; seronegative for syphilis; Symptoms of pulmonary embolism.
Age
From 18 years old to 99 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
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
Research Ethnic Committee, Breast Cancer Research Center (BCRC), Motamed Cancer Institute, Tehran Un
Street address
No 146, Corner of Southern Gandhi Street, Vanak Square
City
Tehran
Postal code
Approval date
2016-08-14, 1395/05/24
Ethics committee reference number
IR.ACECR.IBCRC.REC.1395.13

Health conditions studied

1

Description of health condition studied
Acute Respiratory Distress Syndrome
ICD-10 code
J80
ICD-10 code description
Acute Respiratory Distress Syndrome

Primary outcomes

1

Description
dose of third vasopressor
Timepoint
6 hours after injection
Method of measurement
1-Norepinephrine: 10 μg per min 2- Phenylephrine: 100 μg per min 3- Dopamine: 10 μg / kg per min 4- Epinephrine: 0 - 1 μg / kg per min in serum

2

Description
Hypoxemia
Timepoint
6 hours after injection
Method of measurement
FiO2 ≥0.2 or PEEP = 5 cmH2O or more

3

Description
Occurrence cardiogenic cardiac or ventricular arrhythmia
Timepoint
6 hours after injection
Method of measurement
Clinical examination and electrocardiogram

Secondary outcomes

1

Description
Cardiac arrest or death
Timepoint
24 hours after injection
Method of measurement
Clinical Examination

2

Description
septicemia
Timepoint
6 hours after injection
Method of measurement
Base on urine and blood laboratory examination

3

Description
rapid clinical instability after injection in the cardiovascular and respiratory systems
Timepoint
30 min after injection
Method of measurement
Change in systolic or diastolic blood pressure, mean arterial blood pressure changes

4

Description
drug toxicity
Timepoint
30 min after injection
Method of measurement
Pulmonary embolism, fever, respiratory inflammation

Intervention groups

1

Description
In the first group of intervention; the intervention is the injection of 1 million stromal cells of embryonic membranes intravenously in 30 minutes.
Category
Treatment - Drugs

2

Description
In the second group of intervention; the intervention is the injection of 2 million stromal cells of embryonic membranes intravenously in 30 minutes.
Category
Treatment - Drugs

3

Description
In the third group of intervention; the intervention is the injection of 5 million stromal cells of embryonic membranes intravenously in 30 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Tehran University of Medical Sciences
Full name of responsible person
Behnam Sadeghi
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Shariati Hospital, Tehran University of Medical Sciences
Full name of responsible person
Behnam Sadeghi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Breast Cancer Research Center (BCRC), Motamed Cancer Institute, Tehran University of Medical science
Full name of responsible person
Behnam Sadeghi
Street address
No 146, Corner of Southern Gandhi Street, Vanak Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Breast Cancer Research Center (BCRC), Motamed Cancer Institute, Tehran University of Medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Breast Cancer Research Center (BCRC), Motamed Cancer Institute, Tehran University of Medical Science
Full name of responsible person
Behnam Sadeghi
Position
Assistant Professor of Immunology & Cell Therapy
Other areas of specialty/work
Street address
No 146, Corner of Southern Gandhi Street, Vanak Square
City
Tehran
Postal code
Phone
+98 21 8867 9402
Fax
Email
bsadeghi@ibcrc.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Breast Cancer Research Center (BCRC), Motamed Cancer Institute, Tehran University of Medical Science
Full name of responsible person
Behnam Sadeghi
Position
Assistant Professor of Immunology & Cell Therapy
Other areas of specialty/work
Street address
No 146, Corner of Southern Gandhi Street, Vanak Square
City
Tehran
Postal code
Phone
+98 21 8867 9402
Fax
Email
bsadeghi@ibcrc.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Breast Cancer Research Center (BCRC), Motamed Cancer Institute, Tehran University of Medical Science
Full name of responsible person
Farshid Alaeddini
Position
Associate Professor of Epidemiology
Other areas of specialty/work
Street address
No 146, Corner of Southern Gandhi Street, Vanak Square
City
Tehran
Postal code
Phone
Fax
Email
falaedini@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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