Stem cell therapy to treat COVID gets nod for trials

CHENNAI: Stem cell-based therapy to treat COVID-19 has received approval “for a clinical trial from the Biological Division of the Drug Controller General of India (DCGI).

The therapy, Mesocel, helps treat COVID-19 pneumonia and acute respiratory distress.

Mesocel has been developed by LifeCell. It is derived from Mesenchymal Stem Cells obtained from donated umbilical cord tissue. The clinical trial will be conducted in two phases that will evaluate the safety and efficacy of Mesocel for the treatment of patients with moderate to severe infection, according to the researchers.

It is a stem cell-based therapy that involves more than 100 million expanded Mesenchymal Stem Cells (MSCs) obtained from donated umbilical cord tissues and are intravenously infused into patients in two doses. The therapy can be undertaken without immune matching between donor and patient.

MSCs isolated from the umbilical cord have a superior expansion capability compared to their adultsourced counterparts.

“This new cell therapy utilising the potent anti-inflammatory, immune-modulating and tissue regenerative properties of MSCs will further strengthen the fight against COVID and help save lives. Interestingly, similar therapies have already progressed to phase III of clinical trials in other countries— not just for COVID treatment but other associated complications—thus offering great hope for Indian patients,” said Mayur Abhaya, managing director, LifeCell.

LifeCell has set up a manufacturing facility on its Chennai campus that is equipped with multiple bioreactors of different sizes. The facility ensures 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 involves over 100 million expanded MSCs from umbilical cord tissues and is intravenously infused in two doses