Stem cell therapy for COVID-19

Phase 3

Recruiting

Conditions: COVID-19 disease.
COVID-19 disease
U07.01

Registration Number: IRCT20211012052743N1

Lead Sponsor: Cell Gene Medicine Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death. Timepoint: Up to 28 days after starting the study. Method of measurement: Patient observation and evaluation of vital signs.

Secondary Outcome Measures

Name	Time	Method
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.