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We are in touch with CDSCO, will submit clinical trial protocol for approval of COVID-19 treatment

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Stempeutics plans to conduct clinical research in Europe and has partnered with a global consortium of cell therapy companies to combat COVID-19. BN Manohar, MD & CEO, Stempeutics reveals more about the partnership and how India is going to be benefitted through this endeavour, in interaction with Sanjiv Das

Stempeutics has partnered with the Global Consortium of cell therapy companies to combat Coronavirus Infections in Europe. Tell us more about the partnership? The global consortium consists of how many countries?

The consortium consists of 12 entities from eight countries (the US, the UK, Germany, Israel, Italy, Switzerland, Slovenia and India). It is led by Dr Miomir Knezevic, CEO & Founder of Educell, Trzin, Slovenia. Stempeutics is the only company from Asia in this consortium. Stempeutics will export its Stempeucel product (clinical grade mesenchymal stromal/stem cells) manufactured in its GMP facility using its patented pooling technology (subject to regulatory approvals).  The Stempeutics facility at Manipal is approved by the DCGI for clinical trial manufacturing as well as for commercial manufacturing.

The partnership talks about combating the disease in Europe. How are India and other nations going to benefit from this?

In the proposed European study, a total of 30 patients will be recruited – who have been clinically determined to have Acute Respiratory Distress Syndrome (ARDS) and tested positive for SARS-CoV-2 and have confirmed COVID-19, are receiving care in the critical care or ICU setting. In principle, the outcome of this meticulously planned clinical study will be applicable to COVID patients in other countries also, including India. But, to bring an early solution to India, we are approaching Indian regulators for approval to conduct similar (not identical) clinical trials.

How can the stem-cell-based product you are developing act against the novel coronavirus infection? Can you elaborate on the science?  What has been the response from ICMR and DCGI?

The final stage of COVID-19 is a patient in the ICU struggling to breathe. Helping them do it with the help of a ventilator is only a coping mechanism, an attempt to keep the patient alive. The real problem for critically ill patients with COVID-19 is an acute inflammation of the lung tissue which doesn’t allow enough oxygen to enter the blood circulation, finally leading to death in 50 per cent of cases.

Today there is no effective clinically tested and approved drug or treatment for ARDS. However, scientists have been exploring the use of mesenchymal stromal/stem cells (MSCs) for over a decade. MSCs have been proven as an anti-inflammatory and have been shown to alleviate ARDS, even in Wuhan, China, during the first wave of the spread of COVID-19 in January. All over the world, many clinical studies employing MSCs for the treatment of COVID-19 respiratory complications are ready to begin.

Stempeutics stem cell product ‘Stempeucel’ is allogeneic, off the shelf, pooled MSCs having anti-inflammatory and immune-modulatory properties which prevent the over-activation of the immune system. Stempeucel products exhibit a wide range of potent therapeutic properties. The product exhibits potent immune-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. Also, the growth factor, Angiopoietin-1 (Ang-1) is effective in reducing alveolar epithelium permeability in the lung permeability. Hence, it is envisaged, Stempeucel will reduce fatal symptoms of COVID-19 induced pneumonia and progress to ARDS. Furthermore, in the biodistribution study of Stempeucel in rats showed that a large portion of intravenously (IV) injected cells were found to be localised in the thoracic cavity. Overall, our preliminary data indicate that IV administered Stempeucel can reach the lung and can induce immunomodulation and repair in the inflamed lung tissue.

What will be the duration of the clinical research and how many patients will be enrolled for it?

The total duration of clinical research planned in Europe will be approximately 12 months. Patients will be administered with the bone marrow-derived MSCs and followed for 29 days after administration. A total of 30 subjects receiving care in the critical care or ICU setting for COVID-19 will be enrolled in this study. Subject to regulatory approvals – the results of this clinical study will be announced in 2021.

Are you in touch with Indian regulatory authorities and scientific bodies to research and commercialise your products?

Yes. We are in touch with the Indian regulatory body, CDSCO. Shortly, we will be submitting a clinical trial protocol for approval for treating COVID-19 patients suffering from ARDS due to pneumonia.

Do you think pharma companies will be able to ramp up the production of drugs to tackle the situation effectively?

Yes. Generic pharma companies have the capacity to ramp up the production based on demands.

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