COVID-19 disease. 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 0.5-1 million/kg. This process is performed three times. This
Sponsors
Cell Gene Medicine Company
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients in the acute phase with Laboratory confirmation of SARS-COV-2 infection with RT-PCR 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 mm Hg No history of tumor or malignant disease CRP greater than normal range
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. Any active or treated Cancerous diseases. Creatinine greater than 1.7 mg/dL Co-infection of human immunodeficiency viruses, Hepatitis B, Hepatitis C and Human T-lymphotropic virus Any cardiac hemodynamic disorder Positive PPD test Positive syphilis test Treatment with cytotoxic drugs one month prior study
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: The PSI/PORT score.;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 or Chest X-Ray. Timepoint: After the second and third infusions. Method of measurement: CT scan or plain Radiography. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAliasghar Rezaei
Iranian academic center for education culture and research
Outcome results
None listed