The clinical trial, to be conducted in two phases, will evaluate the safety and efficacy of Mesocel for the treatment of patients with moderate to severe COVID-19.
Leading stem cell bank LifeCell on Thursday said it has received approval from the Drug Controller General of India (DCGI) for a clinical trial of Mesocel to treat patients with moderate to severe COVID-19.
The company has received the approval for the clinical trial of Mesocel, a new therapy derived from mesenchymal stem cells of the umbilical cord tissue, set to treat patients suffering from COVID 19 pneumonia and acute respiratory distress, from the Biological Division of the DCGI, LifeCell said in a statement.
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The clinical trial, to be conducted in two phases, will evaluate the safety and efficacy of Mesocel for the treatment of patients with moderate to severe COVID-19, it added.
“This new cell therapy utilising the potent anti-inflammatory, immune-modulating and tissue regenerative properties of Mesenchymal Stem Cells (MSCs) will further strengthen our fight against COVID-19 and help save lives, which is our primary objective,” LifeCell Managing Director Mayur Abhaya said.
The company has set up a manufacturing facility at its Chennai campus that will further bolster its biologics manufacturing capabilities, LifeCell said.
Equipped with multiple bioreactors of different sizes, the facility ensures an uninterrupted supply of MSCs for timely and affordable treatment by using the bio-reactors to expand the cells in a sterile environment, thereby providing significant advantages from a cost and quality-control perspective, it added.