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)
- Conditions
- Acute Respiratory Distress Syndrome.Acute Respiratory Distress Syndrome
- Registration Number
- IRCT2017010531786N1
- Lead Sponsor
- Breast Cancer Research Center (BCRC), Motamed Cancer Institute, Tehran University of Medical science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;Hypoxemia. Timepoint: 6 hours after injection. Method of measurement: FiO2 =0.2 or PEEP = 5 cmH2O or more.;Occurrence cardiogenic cardiac or ventricular arrhythmia. Timepoint: 6 hours after injection. Method of measurement: Clinical examination and electrocardiogram.
- Secondary Outcome Measures
Name Time Method Cardiac arrest or death. Timepoint: 24 hours after injection. Method of measurement: Clinical Examination.;Septicemia. Timepoint: 6 hours after injection. Method of measurement: Base on urine and blood laboratory examination.;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.;Drug toxicity. Timepoint: 30 min after injection. Method of measurement: Pulmonary embolism, fever, respiratory inflammation.