COVID-19. COVID-19 disease
Conditions
Interventions
Intervention 1: Intervention group: In this group, umbilical cord Wharton’s jelly mesenchymal stem cells are infused at an initial dose of 0.5-2 milion/ kg. This process is performed on the first, thi
Sponsors
DEY Company
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients in acute phase with Laboratory confirmation of SARS-COV-2 infection, Pneumonia confirmed by chest x-ray or Computed tomography Scan, 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. Creatinine greater than 1.7 mg/dL. Any active or treated Cancerous diseases. Hepatic enzymes three times normal or white blood cell count lower than 3000 per microliter and hemoglobin less than 10 g/dl. Any cardiac hemodynamic disorder. 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 ContactMohamad Fathi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed