Stempeutics, a group company of Manipal Education and Medical Group (MEMG), announced that Drug Controller General of India (DCGI) has granted clearance of the company’s stem cell product StempeuceL for conducting label extension Phase 3 clinical trial in Covid-19 patients suffering from ARDS. Stempeucel product 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. The growth factor, Angiopoietin-1 is effective in reducing alveolar epithelium permeability in the lung and increases rate of alveolar fluid clearance. Stempeucel may also directly transfer mitochondrial DNA to host alveolar cells, it secrete micro-vesicles which decreases inflammation and alveolar oedema which helps in repair of lungs.

Commenting on this initiative, Dr Sudarshan Ballal, Chairman – Manipal Hospitals & Chairman - Stempeutics said, 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. Treating ARDS patients with allogeneic expanded bone marrow derived MSCs could alleviate and ameliorate 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.”  

Dr. Pawan Gupta, Senior Vice President, Stempeutics said, “No clinically trialed drugs nor therapies exist today for Covid-19 ARDS, however Mesenchymal Stromal Cells (MSC) have been thoroughly researched in previous years and have also been applied during the first and second wave of the spread of Covid-19 in many countries in numerous clinical trials. Stempeucel because of its anti-inflammatory and immunomodulatory properties has the potential to be used in treatment of Covid–19 induced pneumonia leading to ARDS, which is the main cause of death in this disease.  It is hypothesized that MSCs could reduce the acute lung injury and inhibit the cell-mediated inflammatory response induced by SARS-CoV-2. Furthermore, as MSCs lack the angiotensin-converting enzyme 2 (ACE2) receptor that SARS-CoV-2 uses for viral entry into cells, so these cells are not permissive to SARS-CoV-2 infection, supporting the safety of MSCs as potential therapy for COVID-19”.  

About Covid-19 Acute Respiratory Distress Syndrome (ARDS):

ARDS or severe acute lung injury is a complex and debilitating disease of the lungs, which continues to have a high mortality rate and huge disease burden on patients. Lungs perform the critical function of supplying oxygen to every cell of the body, and consist of a combined structure of a basic architecture of terminal airways, termed terminal bronchioles. The terminal structures are composed of several respiratory cell types including respiratory epithelial cells, endothelial cells, other stromal cells, and alveolar macrophages, as well as other organ-specific cells that commonly occur in the terminal structures of each organ. Therefore, the pathogenesis of ARDS is most simply described as extensive acute injury of a specific kind of respiratory cell directly by various insults, including infectious agents and/or host immune responses, or secondarily by ischemic insults, such as pulmonary thromboembolism or near drowning.