DCGI approves Clinical Trial of MESOCEL therapy to treat COVID

The clinical trials will be conducted in two phases and will evaluate the safety and efficacy of mesocel for the treatment of patients

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DCGI CDSCO Regulator Drugs Controller General India
DCGI

Last Updated on December 31, 2023 by The Health Master

Chennai: LifeCell, the market leader in stem cell banking has received approval from the Biological Division of the Drug Controller General of India (DCGI) for a clinical trial on mesocel therapy, where Mesenchymal Stem Cells (MSCs) obtained from the umbilical cord tissue is set to treat patients suffering from COVID-19, pneumonia and acute respiratory distress.

The clinical trials will be conducted in two phases and will evaluate the safety and efficacy of mesocel for the treatment of patients.

The therapy involves 100million + expanded MSCs that are obtained from donated umbilical cord tissue and are intravenously infused in patients through two intravenous doses.

The immune between donor and patient doesn’t have to necessarily match for the therapy to take place. LifeCell has set up a Chennai campus to bolster its biologics manufacturing capabilities and further ramp up its production.

While explicating on company’s hopes from the trials, Mayur Abhaya, Managing Director, LifeCell said “This new cell therapy utilising the potent anti-inflammatory, immune-modulating, and tissue regenerative properties of MSCs will further strengthen our fight against COVID-19 and help save lives, which is our primary objective.

Interestingly, similar therapies have already progressed to phase III clinical trials in other countries not just for the treatment of COVID-19 but other associated complications, thus offering great hope for Indian patients suffering from severe COVID-19.”,

LifeCell has become the first stem cell bank to get DCGI’s approval for using MSCs derived from the umbilical cord tissue to treat COVID-19, the company said in a statement.

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