Last year, Indian authorities stopped a potential clinical trial, ReAnima, in India that aimed to use stem cells to reverse brain death in people. However, the scientists’ undying passion to pursue this research led them to the final stages of potentially executing it in the coming months somewhere in Latin America.

A fusion of procedures

Bioquark, a Philadelphia-based biotech firm, is spearheading this highly controversial study. It targets to restore life in 20 people who have been declared clinically brain-dead by using combined methods. Some of these include the coupling of mesenchymal stem cell injections with peptides that has been said to promote brain cell growth, transcranial laser therapy over 15 days in efforts to ‘jump-start’ brain cells and median nerve electrical stimulation to invigorate the senses.

They believe that this method can stimulate neuron growth and spur them to one another to subsequently bring the brain back to life.

“It’s our contention that there’s no single magic bullet for this, so to start with a single magic bullet makes no sense,” said Ira Pastor, Bioquark’s CEO. “Hence, why we have to take a different approach.”

Some of the individual interventions from this particular combination have hinted at possible benefits for some populations in early stages of research. For example, stem cell injections into the brain or spinal cord have been linked to the treatment of brain injuries. Despite this, there is no indication that any form of intervention – individual or collectively – can revive the brain-dead. Scientists from Bioquark have not even trialed their methods on animals yet.

Buzzing questions; no answers – not quite yet

This same study was initially set in Rudrapur, India but was terminated by the Indian Council of Medical Research (ICMR) in November 2016 prior to patient recruitment citing regulatory relapses. Pastor admitted that at the time that they faced trouble in convincing relatives to allow the enrolment of brain-dead accident victims.

Many questions have been raised in regard to this research. For example, are the family members going to complete trial paperwork for the people participating? If the person did regain brain activity, would functional abilities be fully restored? Will this long-shot trial unnecessarily raise the hopes of distraught family members? Researchers from Bioquark have not gotten to even thinking about them as yet.

“Of course, many folks are asking the ‘what comes next?’ question,” said Pastor.

“While full recovery in such patients is indeed a long term vision of ours, and a possibility that we foresee with continued work along this path, it is not the core focus or primary endpoint of this first protocol.”

Without full function, the revived person will need around-the-clock care. An orthopaedic surgeon who was leading the trial in India, Himanshu Bansal said he had taken out an insurance plan to cover such patients in such instances.

Ethical and practical concerns raised

This controversial experiment had gained the attention of many experts, mostly questioning its potential. In a 2016 editorial, neurologist Dr Ariane Lewis and bioethicist Arthur Caplan wrote that the trial “borders on quackery”, “has no scientific foundation”, and gave families “a cruel, false hope for recovery.”

Dr Ed Cooper, an orthopaedic surgeon who pioneered the median nerve stimulation study, also stated unequivocally that there is no way this technique could work on someone who is brain-dead. The technique relies on a functional brainstem to work. Pastor agreed with Cooper’s theory; but argued that there is “a small nest of cells” that still functions in brain-dead patients.

On top of it all, results in the trial might not be exclusively due to the treatment because there is no definitive way to measure brain death. To counter, Bioquark is going to depend on local physicians in the host country to make the call.

“We’re not doing the confirmatory work ourselves,” said Pastor. A survey of 38 papers published over 13 years noted that if American Academy of Neurology guidelines for brain death had been met, brain function has never been restored n brain-dead people.

Dr Charles Cox, a paediatric surgeon, said, “It’s not the absolute craziest thing I’ve ever heard, but I think the probability of that working is next to zero.”

Cox explained that studies have proven the ability of cells from the brain’s subventricular zone to thrive in culture even after the person is declared dead. That being said, it is unlikely the study will facilitate the growth of neurons in a similar manner as blood flow is nearly always lost in brain-dead patients.

Pastor still stands with Bioquark’s aim and believes it will work. “I give us a pretty good chance. I just think it’s a matter of putting it all together and getting the right people and the right minds on it.” Cox is less hopeful stating, “I think [someone reviving] would technically be a miracle. I think the pope would technically call that a miracle.” MIMS

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