LifeCell’s Mesocel gets nod for clinical trial from DCGI
Therapy to treat patients with moderate to severe COVID 19
Bengaluru, September 21, 2021: LifeCell, India’s leading stem cell bank and diagnostic solutions provider’s latest therapy to treat COVID 19, Mesocel, today received an approval for clinical trial from the Biological Division of the Drug Controller General of India (DCGI). Derived from Mesenchymal Stem Cells obtained from donated umbilical cord tissue, Mesocel is set to treat patients suffering from life-threatening COVID19 pneumonia and acute respiratory distress. 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.
Mesocel is a pioneering stem cell-based therapy that could potentially treat COVID19 pneumonia and acute respiratory distress. The therapy involves 100million + expanded Mesenchymal Stem Cells (MSCs) that are obtained from donated umbilical cord tissue and are intravenously infused into patients in two intravenous doses. The therapy can be undertaken without need for immune matching between donor and patient.
LifeCell has set-up a manufacturing facility at its Chennai campus that will further bolster its biologics manufacturing capabilities. 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 is well known that MSCs isolated from the umbilical cord have a superior expansion capability compared to their adult-sourced counterparts. The facility meets the current good manufacturing practices (CGMP) guidelines which ensure that all manufactured biological products meet the regulatory standards set by the national as well as international agencies and also offer significant cost and quality-control related advantages.
"Over the last year, LifeCell has supported over a million Indians with quick and reliable COVID-19 RT-PCR testing. 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.", said Mayur Abhaya, Managing Director, LifeCell.
Ishaan Khanna, Chief Executive Officer, LifeCell, further added, “LifeCell has been striving to offer its cord blood banking customers with several innovative industry-first launches including the novel community banking initiative and StemMatch, and FamilyFloater programs which offer unmatched and rapid access to matching stem cells to the families for a transplant when time matters the most. With this approval, LifeCell has become the first stem cell bank to get DCGI’s approval for using MSCs derived from the umbilical cord tissue. This has not only once again established us as the leaders but also enabled us to offer more value to our customers who shall receive complimentary access to the mesenchymal stem cells following the launch.”