BENGALURU: A Bengaluru stem cell-based R&D and drug development firm has sought permission from the Drug Controller General of India (DCGI) to test a drug on Covid-19 patients in India.
Stempeutics Research, part of the multi-billion dollar Manipal Education and Medical Group, says the drug, stempeucel, has shown anti-inflammatory properties that could be useful in improving the lung condition of those with Acute Respiratory Distress Syndrome (ARDS), a condition critical Covid-19 patients are known to suffer from.
BN Manohar, CEO & MD, Stempeutics, told: “The research on stempeucel has been going on for years. It works on critical limb ischemia (CLI) among other kinds of ailments, which require stem cell therapy to reduce inflammation. We already have conditional marketing approval from DCGI specifically for CLI.”
The drug is based on mesenchymal stem cells (MSC) and in the wake of the pandemic, the firm did lab tests to check if it improves lung condition and found positive results. The drug does not stop the virus from replicating, but only helps improve lung condition.
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“It’s now known that Covid-19 affects the pulmonary system eventually leading to ARDS in critical patients. Once patients reach that stage, the fatality is 50%. Our product has shown anti-inflammatory properties that we are confident can improve lung condition of such patients,” Manohar said.
Arguing that since the drug has been tested efficiently for other ailments like CLI, Manohar said: “While testing for other things like CLI, we have proved that the drug is safe to be used on humans, which means that we can straight away go on to testing for its efficacy against ARDS,” adding that its safety test has been conducted on 350 Indians.
He further argued the need to get critical patients off ventilators as soon as possible will become a priority. “Given the fatality rates of those Covid-19 patients with ARDS, the goal is to reduce the time they spend on ventilators because prolonged dependence on the mechanical system is bad. I think this product can improve the lung condition,” he said.
As on Tuesday, Stempeutics was in the process of finalising the design of the test it needs to send to DCGI. “We’ve had our discussions and now, our proposal needs to spell out the details. We need to show how many patients we need to test this on, and what kind of dosage and protocols need to be followed,” Manohar added.