Rounak Dubey, MD, DNB
ISCT Telegraft, Junior Associate Editor
Department of Transfusion Medicine
All India Institute of Medical Sciences
India has entered into the sixth week of a nationwide lockdown, which came into effect on 25 March 2020, when confirmed COVID-19 patients were around 500. As of April 29, the number of confirmed cases stands at 31,332(including 1007 deaths). For a densely populated nation with more than 1.3 billion people, these numbers allude that the situation has been kept under control so far. One can only hope that easing the lockdown won’t let the genie out of the bottle. As most of the resources have been engaged in combating the pandemic, everything else seems to have taken a backseat for a while.
It has presented new challenges to the budding field of cellular therapy in India, ranging from maintenance of the supply chain to follow up of the patients. Stempeutics Research Bangalore, a mesenchymal stromal cell company, is presently carrying out three MSC based phase III clinical trials (Critical Limb Ischemia due to atherosclerotic peripheral artery disease, non-healing diabetic foot ulcer and Osteoarthritis Knee) and one Phase IV trial in Critical limb ischemia due to Buerger’s disease using their allogenic, pooled MSC product stempeucel®. The follow up of the patients has become quite difficult as they are not able to visit the clinical trial sites due to the lockdown. They are relying more on telephonic follow up (in some of the cases) to get regular feedback about the well-being of the patients. This could lead to a lot of protocol deviation and may miss a few important efficacy visits of the enrolled patients. In all the new ongoing trials, the patient recruitment has been stopped, this delaying the timelines for completion of the study. The company is also in the process of getting approval from the regulatory agency for starting a clinical trial using MSCs for the treatment of ARDS due to Pneumonia in COVID-19 patients.
(Thanks to Dr Pawan Kumar Gupta, MD, DNB, PhD for sharing the information)
On another front, the use of convalescent plasma from recovered COVID-19 patients, has been in the limelight recently. A multicentric, phase II randomized controlled trial to assess the safety and efficacy of convalescent Plasma to limit COVID-19 associated complications has been initiated by the Indian Council of Medical Research(ICMR). The regulatory authorities are also granting accelerated approval for the same. The initial results of this therapy have been encouraging.
Many Indian firms have also joined the quest for developing a vaccine against the disease, including The Serum Institute of India , which is the world’s largest vaccine manufacturer in terms of number of doses produced. As far as the other drugs(especially chloroquine) are considered, the “Infodemic” had reached here much earlier than the actual pandemic, but any conclusive evidence regarding its efficacy is still awaited. Maybe, it will take more than the lock, stock, and barrel approach for finding the “magic bullet” that everyone is eagerly looking for.