IRCT20211012052743N1
Recruiting
Phase 3
Clinical trial study of safety and efficacy assessment of human umbilical cord matrix mesenchymal stem cell infusion on the treatment of new coronavirus 2019 pneumonia in humans
Cell Gene Medicine Company0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cell Gene Medicine Company
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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