Fund crunch puts brakes on clinical trials

BENGALURU: Research on cytokine therapy, which has the potential to help treat Covid-19, has been stalled due to lack of funding.A team of doctors at HCG Cancer Centre, which is studying the potential of cytokine therapy in treating Covid-19, obtained approval from the Drug Controller of India (DGCI) last year to conduct Phase 2 clinical trials. However, a lack of funding has put a brake on their research, as applications for grants to both government agencies and non-governmental organisations six months ago, have received no response yet.

Cytokines are a group of proteins secreted by immune cells and help the body switch from passive to active immunity to counter Covid-19. The therapy involves imcyte cytokine injections and takes about five minutes. The therapy, which is already being used globally to treat certain types of cancer, is meant for mild to moderate Covid-19 patients so that their condition does not worsen. 

“Animal studies, pre-clinical study and Phase-1 trials (done on healthy individuals) showed that cytokine therapy is safe, potentially effective and enhances the immune system. In Phase 2 we have to involve Covid-19 patients. We have already spent more than Rs 75 lakh and need Rs 50 lakh for Phase 2,” said Dr Vishal Rao, chief of head and neck surgical oncology and robotic surgery at HCG Cancer Centre, and one of the researchers.

Doctors at HCG are also exploring the use of mesenchymal stem cells extracted from the bone marrow to reduce mortality among Covid-19 patients with Acute Respiratory Distress Syndrome and received approval from the DGCI a month ago. 

“Mesenchymal cells will have a role to play in ICU patients. We are the first in the country to get approval for clinical trials. We need grants for this too, and have applied to various organisations. As the safety of mesenchymal cells is already proven for treatment of other diseases, the approval has been given to us directly for Phase 2/3,” Dr Vishal Rao said.

The treatment involves injecting critically-ill patients on ventilator with mesenchymal stem cells over a period of a few hours. These cells have anti-inflammatory properties and reduce the cytokine storm and inflammation in the lungs.