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.
‘Permissions’ The ‘permissions’ were granted by an Institutional Review Board (IRB), an independent ethics committee, which in this case was made of a motley group of local doctors from private hospitals in Rudrapur, a senior official from Pantnagar University and a retired bureaucrat from the Uttar Pradesh health department.
Usually, IRBs are approached for permissions after approval from the Drug Controller General of India (DCGI); in this case, Dr. Bansal says they were not required since the trial subjects are already dead.
“The rules apply only on living patients. We will recruit people who are declared brain dead. We have already registered the trial at CTRI, which is the only requirement since there is a grey area legally when it comes to experimenting on brain dead patients,” Dr. Bansal acknowledged during a conversation at Anupam Hospital, the ‘trial site’.
Project ReAnima Project ReAnima was born from “anecdotal studies” in which Dr. Bansal claims he induced a certain degree of sensation in brain dead patients. The trial’s technical name is ‘First In Human Neuro-Regeneration & Neuro-Reanimation’ and the first phase will be a non-randomised, single group ‘proof of concept’ conducted at Anupam Hospital. What this means is, for six weeks, after a patient is declared brain dead by any hospital in the area, Dr. Bansal will study the effects of stem cell therapy, Median Nerve Stimulation and a laser therapy on comatose patients. One-third of the funds for this will be given by BioQuark.
Dr. Bansal has not “recruited” any patients as yet.
The top floor is being cleared to accommodate the study subjects. “We are approaching hospitals nearby to contact us when they have a brain dead patient,” informed Dr. Bansal.
Dr. Bansal claims that he has been working on comatose patients since 2009 and has had some success with two patients — one based in Dwarka, New Delhi and another a world renowned athlete.
“One patient was brain dead but after we started our experiments, she started responding to pain stimulus — meaning her blood pressure would change every time she felt pain. But I cannot give you more details due to confidentiality agreements with my patients,” he says.
He clarifies he never claimed that that he can reverse brain death or revive patients.
“I am hoping to expand the window of when brain death is determined from the current standard of 6 hours,” he adds.
What about ethical and religious implications of this study on the families? “Most families will be grateful that their loved ones still have a chance,” Dr. Bansal informed, adding that he had not planned for any counselling that might be required by families. The costing for the entire clinical trials had also not be done yet.
When asked about his training as an orthopaedic surgeon, Dr. Bansal said he was an expert in the central nervous system and, “since the pathophysiology is the same, I don’t need to be a neuroscientist. I won’t be cutting open the patients.”
But when will these ‘patients’ arrive? Dr. Bansal says he expects his first recruit as early as this week. The chances that this will be a victim of a road accident are very high, he thinks.
