Indian authorities last year pulled the plug on a dubious clinical trial to reverse brain death in 20 people. But it seems that the determination of the leaders of the trial is undying. They have revived their plans and will announce a new trial in the coming months that will take place somewhere in Latin America, stat reports.
The trial, led by Philadelphia-based biotech company Bioquark, aims to restore life to those declared clinically brain dead by using a potpourri of methods — combining mesenchymal stem cell injections with peptides said to stimulate brain cell growth. promote, according to transcranial laser therapy. to jump-start brain cells, and electrical stimulation of the median nerve (a major nerve that runs through the arm) to stimulate the senses.
Separately, some of these interventions have suggested potential benefits for some patient populations in preliminary research. For example, early studies suggest that stem cell injections into the brain or spinal cord may help some people with brain injuries. But there’s no evidence that the interventions — individually or together — can bring back brain-dead patients. Bioquark and partners haven’t even tried their hodgepodge method on animals.
Last November, the Indian Council of Medical Research (ICMR) halted the trial, which was taking place in Rudrapur, India, before any patients were recruited. The ICMR cited several regulatory shortcomings. Ira Pastor, CEO of Bioquark, has admitted that Science at the time, the team running the clinical trial, called ReAnima, also struggled to convince relatives to let them enroll brain-dead accident victims.
Researchers had flatly determined that the idea is “far-fetched,” bordering on “quackery,” and has “no scientific basis.” Ethicists also chided the plan and worried about the toll it would take on grieving family members. Even if the researchers manage to restore a minimally conscious state, it could be traumatizing for family members. And without restoring full function, it would mean that the revived person would require full-time care. Himanshu Bansal, the orthopedic surgeon who led the trial in India, told The Wire last year that he had taken out an insurance plan to cover such patients.
But researchers don’t think it will come to that. “It’s not the absolute craziest thing I’ve ever heard,” said Charles Cox, a pediatric surgeon who studies mesenchymal stem cells at the University of Texas Health Science Center at Houston. stat. “But I think the chance of [Bioquark’s plan] working is almost zero.”
Pastor is still optimistic about their revived plan. “I give us a good chance,” he said. “I just think it’s a matter of putting everything together and getting the right people and the right minds involved.”