Stempeutics bags DCGI nod for Phase 3 trial on Stempeucel for COVID patients suffering from ARDS
New Delhi: Stempeutics, a group company of Manipal Education and Medical Group (MEMG), on Tuesday said it has received DCGI clearance to conduct Phase 3 clinical trial on its product for treating COVID-19 patients suffering from acute respiratory distress syndrome (ARDS).
The company will be using its stem cell product, Stempeucel, for conducting the label extension Phase 3 clinical trial.
The product is already approved for marketing for the treatment of critical limb ischemia by the Drugs Controller General of India (DCGI).
Stempeucel exhibits potent immuno-modulatory and anti-inflammatory properties which could help in reducing the inflammation caused due to the cytokine storm elicited by the body's immune cells in response to SARS-CoV-2 (COVID-19) related infection in the lungs, Stempeutics said in a statement.
"Coronavirus third wave appears to be mild-to-moderate. But the most severely affected CoV-2 infected patients will often go on to develop ARDS which necessitates assisted ventilation to preserve breathing and lung function.
"Moreover, many ARDS patients may also experience an acute inflammatory response (cytokine storm) which can result in long-term damage to lung tissue and lung function," Stempeutics Chairman Sudarshan Ballal noted.
Treating ARDS patients with allogeneic expanded bone marrow derived MSCs could alleviate lung inflammation and compromised lung function and significantly reduce the time required for patients to be ventilated, he stated.
"The results of this trial would be very crucial in confirming this," Ballal said.
Headquartered in Bengaluru, Stempeutics is an advanced clinical-stage biotech company.
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