Two US biotech companies have been given the green light to see if it is possible to regenerate the brains of dead people. Bioquark Inc., in collaboration with Revita Life Sciences, has been given ethical permission by US health authorities to recruit 20 patients who have been declared clinically dead from a traumatic brain injury to test whether parts of their central nervous system (CNS) can be brought back to life.
Scientists working on the ReAnima Project will use a combination of therapies, which include injecting the brain with stem cells and a cocktail of amino acids, as well as deploying lasers and nerve stimulation techniques which have been shown to bring patients out of comas. The first trial will be a non-randomised, single group ‘proof of concept’ trial and will take place at Anupam Hospital in Rudrapur, Uttarakhand, India.
The trial participants will have been certified dead and only kept alive through life support. They will be monitored for several months using brain imaging equipment to look for signs of regeneration, particularly in the upper spinal cord – the lowest region of the brain stem which controls independent breathing and heartbeat.
India’s The Hindu newspaper reports: Flanked by a restaurant-cum-bar on one side and a gym on the other, Anupam Hospital is like any other small town private nursing home in India but for one minor detail: Project ReAnima, the world’s first clinical trial on the revival of brain dead patients.
The three-storey hospital is run by Dr. Himanshu Bansal, an orthopaedician with a keen interest in neuroscience. He admits to not having practised medicine since 2005. “I have always preferred research over practising medicine,” said Dr. Bansal, a slightly overweight, affable, eager-to-please man in his early forties, who wears confidence as a second skin.
He is the principal investigator of the ‘groundbreaking’ project after it became known that this cutting-edge clinical trial project had been given ethical approvals to recruit 20 clinically dead patients by government authorities. The project is a joint-venture between the Philadelphia-based biotech company Bioquark Inc, Revita Life Science (of which Dr. Bansal is the owner) and Anupam Hospital in Rudrapur, Uttarakhand — a town so inconsequential that it is best known for bad roads and proximity to Nainital.
At the heart of the trial is a massive regulatory gap, one which Dr. Bansal has masterfully exploited. India currently has no laws for clinical trials on ‘living cadaver’ or brain dead patients. “And since India has no laws, no permissions are required,” sums up Dr. C.M. Gulhati, editor of medical journal Monthly Index of Medical Specialities (MIMS) and an expert in bioethics.
In an interview with India’s The Wire, Dr. Bansal reported that he had not thought of what he would do with the research subjects if he did succeed in reviving them. “We hadn’t thought of that. We had not planned for it,” Bansal said. Now, he says, he has purchased an insurance policy to treat and support the subjects if they do come back from brain-death.