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First in Maharashtra: Pune medical college gets ICMR nod to start clinical trials for convalescent plasma therapy
BJ Medical College, Pune, has become the first medical institute in Maharashtra to receive an approval from the Indian Council of Medical Research (ICMR) to run
BJ Medical College, Pune, has become the first medical institute in Maharashtra to receive an approval from the Indian Council of Medical Research (ICMR) to run clinical trials for the convalescent plasma therapy. The blood sample of the first donor has been sent for antibody titre to the National Institute of Virology (NIV), Pune.
Convalescent plasma therapy involves injecting patients with plasma from the blood of recovered patients. In this process, the plasma with antibodies is transfused into an infected person to boost his immunity response to the novel coronavirus.
To start a clinical trial, a medical institute has to undergo a four-stage approval process — permissions from the institute, ethics committee, drug controller and lastly ICMR. In Mumbai, Lilavati Hospital at Bandra tried to treat a Covid-19 patient through plasma therapy. However, they are yet to receive the final approval from ICMR.
“BJ Medical College is the first medical institute to pass through all four stages of approvals. We will now run clinical trials that will help establish if plasma therapy is effective for the treatment of patients,” said Dr Sanjay Mukherjee, secretary, Medical Education and Drugs Department.
ICMR, however, has made it clear that it does not recommend plasma therapies as treatment outside clinical trial settings. In the absence of a vaccine or a specific drug, plasma therapies have been tested globally, albeit in limited numbers, as a treatment for patients who show severe complications due to coronavirus.
Dr Mukherjee explained that there is at present a belief among medical fraternity that antibodies developed among recovered patients may help neutralise the virus—Sars-CoV-2 that causes Covid-19. “The theory can be established by testing it (with approval) on patients through clinical trials,” he said.
Murlidhar Tambe, Deputy Dean of BJ Medical College said that all the patients who will participate in the trial will be covered under insurance. Without disclosing much information, he said, “We have procured equipment to run the trial. But we are waiting for the final insurance reports of the patients to go ahead with the trial. We need cured people to come forward to donate their blood for the therapy”
The college has collected blood from a male donor in his late 20s who has recovered from Covid-19 for over a month. The blood has been sent to NIV for extraction of the plasma. Once they get a green signal from the laboratory, they will transfuse it into a Covid-19 patient. As per sources, the first transfusion will be conducted on Monday. The Food and Drugs Administration (FDA) has already permitted the plasmapheresis (the process in which plasma is separated from the blood cells).
Normally, before starting with the clinical trials, it is tested on animals. But as plasma therapy is already an established form of treatment in other diseases, initial testing on animals is not needed.
“Patients will be invited to participate in randomised control trials with their approval. Once we can confirm that it is effective on humans with Covid-19, the therapy will be scientifically considered for the treatment of patients with novel coronavirus,” Mukherjee added.
