| Trial registration number
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IRCT20211012052743N1 |
Full text link
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/59339
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First author
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Aliasghar Rezaei
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Contact
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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info@cellgenemedicine.com
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Registration date
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-11-06
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Recruitment status
Last imported at : Nov. 22, 2022, 4 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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
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Exclusion criteria
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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
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Number of arms
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Cell Gene Medicine Company
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Inclusion age min
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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85
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Countries
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe/critical disease at enrollment
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Severity scale
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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7: Severe/critical disease at enrollment
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Total sample size
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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60
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primary outcome
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Death
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Notes
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Nov. 6, 2021, 2:33 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 792, "treatment_name": "Mesenchymal stem cells (wharton jelly)", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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