- Stempeutics will test its stem cell product Stempeucel® for Acute Respiratory Disease Syndrome (ARDS) caused by COVID-19 Pneumonia.
- Consortium consists of 12 entities from 8 countries (USA, UK, Germany, Israel, Italy, etc.). Consortium is led by Dr. Miomir Knezevic, CEO & Founder of Educell Ltd, cell therapy service, Trzin, Slovenia.
- Stempeutics is the only company from Asia in this consortium. Stempeutics will export its Stempeucel® product (clinical grade MSCs- mesenchymal stromal/stem cells) manufactured in its GMP (Good Manufacturing Practice) facility using its patented pooling technology (subject to regulatory approvals).
- The consortium has submitted a project entitled the Fight Against Corona! (FAC!) for Euro 8.3 million funding to the European Commission (EU funding programme H2020)
- Stempeutics is also working closely with agencies in India for making these solutions available in India
Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), announced today 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 Ltd, 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%, 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 of the Global Consortium and Founder of Educell said, “We are happy to partner with Stempeutics since its product Stempeucel® is already designated as an ATMP1 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"
Mr. BN Manohar, CEO of 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 for the 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 N S, 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%), 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".
Mr. B N Manohar - MD & CEO, Stempeutics Research
Manohar is the MD & CEO of Stempeutics Research – a leading stem cell research and product development company in India. He earned his B.E. degree in Electronics & Communication from REC Trichy in 1977. Post that he did M.E. in Computer Science from College of Engineering, Guindy. Manohar has transformed Stempeutics – a life science start-up from R&D to Commercialization stage with Global recognition. Stempeutics has developed an innovative drug called "Stempeucel" for addressing major unmet medical needs in India and Globally. This drug developed by an Indian company has received many Global Recognitions. Fourteen countries including US & Japan has granted patent for the novelty and inventiveness of the drug. Europe has recognized this drug by granting Advanced Therapy Medicinal Product classification and Orphan Drug Designation. Recently it became the FIRST stem cell product to be approved by DCGI for conditional marketing for treating patients suffering from life threatening disease call Buerger's Disease. Stempeutics has put India on the "World map of Regenerative Medicine". Under Manohar's leadership Stempeutics has been recognized as India's hottest start-ups by Business Today in 2008 and Karnataka Government bestowed "Emerging Company of the Year award" in 2011 and 2013. In 2017 Manohar was awarded "Biotechnologist of the Year" award by Wockhardt Foundation, India. He raised US$ 10M in 2009 by establishing business alliance with major pharma company Cipla. Recently Stempeutics has tied up with Alkem Labs for Osteoarthritis indication. Prior to Joining Manipal Group, Manohar has had 12 years successful stints at Wipro GE Medical Systems. At GE Medical he has handled multiple senior assignments including Vice President – Customer Service where he received GE Asia Service Award for highest revenue growth in 1998. Currently Manohar serves in the Boards of Stempeutics and MentisSoft.
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