COVID-19. Severe Acute Respiratory Syndrome coronavirus
Conditions
Interventions
Intervention 1: Intervention group: In this group, mesenchymal stem cells will be injected at an initial dose of 0.5-1 milion/ kg. This process will be performed on the first, third and sixth days. Th
Sponsors
MOM research and innovation center
Eligibility
Sex/Gender
All
Age
18 Years to 95 Years
Inclusion criteria
Inclusion criteria: Patients in acute phase Laboratory confirmation of SARS-COV-2 infection Pneumonia confirmed by chest x-ray or tomography Respiratory rate> 30 times / minute Oxygen Saturation less than 93% Arterial oxygen partial pressure (Pao2) /oxygen inhalation(Fio2) less than 300 mmHg No history of tumor or malignant disease
Exclusion criteria
Exclusion criteria: Pregnant patient with a positive pregnancy test or during lactation or who is planning to become pregnant during the study The definitive history of acquired or inherited immune deficiency diseases The definitive psychotic illness A history of serious mental illness or a history of suicide The use of NG tube Creatinine greater than 1.7 or hepatic enzymes three times normal or white blood cell count lower than 3000 and hemoglobin less than 10 Co-infection of human immunodeficiency viruses, Hepatitis B, Hepatitis C and Human T-lymphotropic virus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death. Timepoint: Up to 28 days after starting the study. Method of measurement: Patient observation and evaluation of vital signs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Pneumonia Severity Index. Timepoint: Up to 28 days. Method of measurement: PSI.;Evaluation of oxygen supply index. Timepoint: Discharge from ICU. Method of measurement: Pulse Oximeter.;C- Reactive protein. Timepoint: 28 days or until the marker is normalized. Method of measurement: Blood sample.;Procalcitonin. Timepoint: Until the marker is normalized. Method of measurement: Blood sample.;Lymphocyte count. Timepoint: Until the marker is normalized. Method of measurement: CBC.;Counting of CD3 +, CD4 + and CD8 + T cells. Timepoint: Before the first injection and after the third injection. Method of measurement: Flow cytometry.;+ CD4 + / CD8 ratio. Timepoint: Before the first injection and after the third injection. Method of measurement: Flow cytometry.;Improve pneumonia evaluated by CT scan. Timepoint: After the second and third infusions. Method of measurement: CT scan. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNader Tavakoli
Iran University of Medical Sciences
Outcome results
None listed