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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)

using Human decidua stromal cells for the treatment of acute respiratory distress syndrome (ARDS), Phase 2

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017010531786N1
Enrollment
15
Registered
2017-03-27
Start date
2017-01-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome. Acute Respiratory Distress Syndrome

Interventions

Intervention 1: In the first group of intervention
the intervention is the injection of 1 million stromal cells of embryonic membranes intravenously in 30 minutes. Intervention 2: In the second group of intervention
the intervention is the injection of 2 million stromal cells of embryonic membranes intravenously in 30 minutes. Intervention 3: In the third group of intervention
the intervention is the injection of 5 million stromal cells of embryonic membranes intravenously in 30 minutes.
Treatment - Drugs
In the first group of intervention
the intervention is the injection of 1 million stromal cells of embryonic membranes intravenously in 30 minutes.
In the second group of intervention
the intervention is the injection of 2 million stromal cells of embryonic membranes intravenously in 30 minutes.
In the third group of intervention

Sponsors

Breast Cancer Research Center (BCRC), Motamed Cancer Institute, Tehran University of Medical science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehnam Sadeghi

Breast Cancer Research Center (BCRC), Motamed Cancer Institute, Tehran University of Medical Science

bsadeghi@ibcrc.ir+98 21 8867 9402

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026