Stem cell treatment for COVID-19

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2020
INTERVENTION: 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, third and sixth days. This intervention is done along with other standard treatments for this type of patients, varying in severity of COVID‐19 Infectious, and in accordance with national and international guidelines. Intervention 2: Control group: This group, like the intervention group, will receive all standard medication according to national and international guidelines, depending on the severity of COVID‐19. But on the first, third and sixth day, placebo (normal saline) is infused. CONDITION: COVID‐19. ; COVID‐19 disease U07.01 PRIMARY OUTCOME: Death. Timepoint: Up to 28 days after starting the study. Method of measurement: Patient observation and evaluation of vital signs. SECONDARY OUTCOME: + CD4 + / CD8 ratio. Timepoint: Before the first injection and after the third injection. Method of measurement: Flow cytometry. C‐ Reactive protein. Timepoint: 28 days or until the marker is normalized. Method of measurement: Blood sample. Counting of CD3 +, CD4 + and CD8 + T cells. Timepoint: Before the first injection and after the third injection. Method of measurement: Flow cytometry. Evaluation of oxygen supply index. Timepoint: Discharge from ICU. Method of measurement: Pulse Oximeter. Evaluation of Pneumonia Severity Index. Timepoint: Up to 28 days. Method of measurement: PSI. Improve pneumonia evaluated by CT scan. Timepoint: After the second and third infusions. Method of measurement: CT scan. Lymphocyte count. Timepoint: Until the marker is normalized. Method of measurement: CBC. Procalcitonin. Timepoint: Until the marker is normalized. Method of measurement: Blood sample. 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
Epistemonikos ID: dd91188f5066ea0c39b0d8d19e0e00fff36606b9
First added on: May 15, 2020