Home / News / India /  Covid: DCGI gives nod to Stempeutics for Phase 3 trial for its product
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Drugs Controller General of India (DCGI) has given nod to Stempeutics, a group company of Manipal Education and Medical Group (MEMG), for conducting Phase 3 clinical trial on its product for treating Covid patients suffering from acute respiratory distress syndrome (ARDS), as per PTI.

Stempeutics 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 DCGI.

In a statement, the company said 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 Covid related infection in the lungs.

Stempeutics Chairman Sudarshan Ballal said Covid 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," he added.

Ballal said 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. "The results of this trial would be very crucial in confirming this," he said.




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