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Stempeutics partners with Global Consortium of cell therapy companies

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Seeking European Commission Funding to Fight Against Corona

Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), recently announced that it has partnered with Global Consortium of cell therapy companies seeking European Commission Funding to Fight Against Corona! (FAC!). Under this partnership, Stempeutics will export its stem cell product Stempeucel (subject to regulatory approvals) for treating critically ill COVID-19 patients with lung disease. First the product will be clinically tested and upon successful outcomes, it intends to export the product on a regular basis. In this connection it is signing up an alliance with Educell, Slovenia.

Currently, no specific drugs or vaccines are available to cure the patients with COVID-19 infection. Mortality in COVID-19 infected patients with the inflammatory lung condition ARDS (Acute Respiratory Distress Syndrome)is reported to approach 50 per cent, and is associated with older age, co-morbidities such as diabetes, cardiovascular disease, COPD (chronic obstructive pulmonary disease), higher disease severity, and elevated markers of inflammation. Current therapeutic interventions (with the exception of ventilators / respirators which are in very short supply) do not appear to be improving in-hospital survival. Hence, there is a large unmet need for a safe and effective treatment for COVID-19 infected patients, especially in severe cases. A promising new therapy for the ARDS, the terminal stage of COVID-19, using MSCs can quickly (2-4 days) reduce inflammation of the lung tissue, and allow patients to more quickly come off of the ventilatory support and hopefully fully recover with less significant lung damage.

Stempeucel is an allogeneic, off the shelf, pooled mesenchymal stromal cells having anti- inflammatory and immune-modulatory properties which prevents the over activation of the immune system. Stempeucel product exhibits a wide range of potent therapeutic properties. The product 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 (COVID-19) related infection in the lungs. Also, the growth factor, Angiopoietin-1 (Ang-1) is effective in reducing alveolar epithelium permeability in the lung. Hence it is envisaged, Stempeucel will reduce the fatal symptoms of COVID 19 induced pneumonia and its progression to ARDS.

Commenting on this initiative, Dr Miomir Knezevic, Leader, Global Consortium and Founder, Educell said, “We are happy to partner with Stempeutics since its product Stempeucel is already designated as an ATMP [1] in Europe and also Stempeucel technology has been patented in many countries in Europe. Stempeutics manufacturing process is scalable and the product is affordable – which are key to meet the demands of COVID-19 patients.”

BN Manohar, CEO, Stempeutics said, “From the clinical data using Stempeucel in different clinical trials in other indications it may be postulated that Stempeucel has the potential capability for treating COVID-19 infection. Together with the safety profile observed from DCGI approved clinical trials involving more than 350 patients injected with Stempeucel by different routes of injection, this therapy may help in mitigating the lung tissue damaging effects of COVID-19 infection.”

Dr Stephen Minger, Scientific Advisor, Global Consortium and ex Global Director of R&D, Cell Technologies GE Healthcare added, “The most severely affected CV-2 infected patients will often go on to develop ARDS which necessitates assisted ventilation to preserve breathing and lung function. Moreover, many ARDS patients will also experience an acute but severe life-threatening 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.”

Dr Raviraja NS, Sr Director, Business Development and Innovation, Stempeutics, said, “Given the severe shortage of ventilators in the world, and the high mortality rate of patients who develop ARDS (approx. 50 per cent), the clinical use of MSCs in COVID-19 ADRS patients could drastically impact on the healthcare burden currently occurring due to very large patient numbers, limited equipment and overworked medical personnel.”

Reference:

[1] ATMP is Advanced Therapy Medicinal Product regulated by EU Act December 7, 2007.

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