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.
A medical marvel if you may call it, but Dr. Himanshu Bansal, an orthopaedician and an expert on 'central nervous system', in a small three-storey hospital in Rudrapur has conducted world's first ever trial to revive brain dead patients using stem cell therapy. The Anupam hospital in Rudrapur which is a small town in Uttarakhand , a state known for its Himalayan Beauty, is now clearing up its top floor to accommodate subjects, which in this case are patients that are declared dead by any hospital in the area.
Dr. Himanshu Bansal. Image Source: drhbf.org
Don't mistake this as an attempt to revive patients back to life or reverse the state of brain death- Dr. Bansal corroborates the above statement by adding that he hopes to expand the window of when brain death is determined from the current standard of 6 hours. With ethical approvals in his hand, he says he expects his first subject to arrive as early as this week with chances of him being a victim of a road accident.
Legal Implications
Being the principal investigator of the 'groundbreaking' project, and after being proved that this cutting-edge clinical trial project works, Government authorities had given ethical approvals to recruit 20 clinically dead patients. With no laws established for the 'living dead' or brain dead patients in India, there were no special permissions or approvals to look into for Dr. Bansal. Any case that requires clinical trials usually needs approvals from Drug Controller General of India before heading on to Institutional Review Board (IRB) for any further procedures.
Contradictory to the above statement, since the recruits were assumedly dead the permissions from the DCG weren't required and all the permissions that were needed were simply granted by the IRB. An interesting point to note, Institutional Review Board, in this case, consisted of nothing more than a bunch of local doctors from private hospitals, some even retired, reported The Hindu.
Clarifying the above details, Dr. Bansal added saying "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."
The birth of the 'groundbreaking' project
Neuroscience. Imagesource:sputniknews.com
A project that is now a joint venture between the Philadelphia-based biotech company Bioquark Inc, Revita Life Science (of which Dr. Bansal is the owner) and Anupam Hospital started in 2009.
Dr. Bansal witnessed success with two patients, one of whom was a world-renowned athlete. By inducing a certain degree of sensation in comatose patients and without cutting them open, the effects of stem cell therapy were studied by him; these are called "anecdotal studies".
Currently, the first phase of the trials is about to start soon, in which for six weeks after the clinically dead patient is got into the facility; the effects will be studied on him using Median Nerve Stimulation and laser therapy. The technical name of the trial is given as 'First In Human Neuro-Regeneration & Neuro-Reanimation'. BioQuark will provide one-third of the funding for this project.
When asked about the ethical and religious implications of this study on the families Dr. Bansal informed, "Most families will be grateful that their loved ones still have a chance."
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