Orgenesis Inc (NASDAQ:ORGS) (FRA:45O) is poised to carry out the first-in-human trial of its Tissue Genesis Icellator2 to treat Acute Respiratory Distress Syndrome (ARDS) caused by the coronavirus (COVID-19) after receiving the go-ahead from the US Food and Drug Administration (FDA).
The cell and gene therapies (CGTs) focused biotech described being granted the Investigational Device Exemption (IDE) approval for the pilot trial as a 'significant milestone' for the company.
The FDA approval covers a study of 21 patients at one clinical site in the US.
The Tissue Genesis Icellator2 is a device, which can rapidly recover high yields of stromal and vascular cells (SVF) from a person's fat tissue, which can then be used therapeutically.
Published nonclinical and clinical evidence indicates that the SVF cells can potentially improve oxygenation, maintain T and B lymphocytes to support antibody production, and may induce an anti-inflammatory effect.
Orgenesis did note in the statement that the numbers of hospitalized patients in the US suffering from ARDS resulting from the virus had declined significantly in recent months. It said it will monitor current clinical needs before beginning this approved pilot trial.
"Orgenesis may consider amending its clinical development plan to target treatment of non-COVID-19 related ARDS or treatment of patients who have not recovered from prior COVID-19 infections (so called “long haulers”)," the company added.
Orgenesis' Point of Care platform is comprised of three enabling components - therapeutics, technology and network.
The company says it identifies promising new therapies and leverages its POCare Platform to provide a 'rapid, globally harmonized pathway' for these therapies to reach and treat large numbers of patients at lowered costs.
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