Stempeutics gets DCGI clearance for Phase 3 clinical trial on its product for treating COVID-19 patients

Stempeutics gets DCGI clearance for Phase 3 clinical trial on its product for treating COVID-19 patients

AgenciesUpdated: Tuesday, January 18, 2022, 03:31 PM IST
article-image
Stempeutics exhibits potent immunomodulatory 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./ Representational Image | Anna Shvets/Pexels

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.

(With inputs from PTI)

RECENT STORIES

India's Gold Reserves Rise By $342 Million, Forex Stands At $699.736 Billion: RBI

India's Gold Reserves Rise By $342 Million, Forex Stands At $699.736 Billion: RBI

Mumbai: Back Pain A 'Silent Epidemic' In India, Says Gautam Adani At Spine Surgery Conference...

Mumbai: Back Pain A 'Silent Epidemic' In India, Says Gautam Adani At Spine Surgery Conference...

Tesla Gears Up For India Debut With Opening Of 1st Store In Mumbai

Tesla Gears Up For India Debut With Opening Of 1st Store In Mumbai

Coconut Oil Prices Triple In A Year; SEA Seeks Urgent Govt Nod For Short-Term Oil, Copra Imports

Coconut Oil Prices Triple In A Year; SEA Seeks Urgent Govt Nod For Short-Term Oil, Copra Imports

Microsoft Makes AI Skills Mandatory, 15,000 Jobs Cut As Company Shifts Focus To Future Tech

Microsoft Makes AI Skills Mandatory, 15,000 Jobs Cut As Company Shifts Focus To Future Tech