In India last year, authorities brought to a halt a dubious clinical trial aiming to reverse brain death. The resolve of the company behind it seems undying; however, as attempts to bring the brain dead back to life could start in a few months.
Bioquark, a Philadelphia-based biotech firm, is in the final stages of preparing a test to regenerate the brains of clinically brain dead patients by injecting them with stem cells. A protein blend is then injected into the spinal cord, which, according to the scientists involved in the trial, will hasten the growth of new neurons.
Subjects will then undergo nerve stimulation and laser therapy for 15 days, which, combined with the previous methods, will hopefully revive the brain.
"It's our contention that there's no single magic bullet for this, so to start with a single magic bullet makes no sense. Hence why we have to take a different approach," Bioquark CEO Ira Pastor told Stat News.
The undead among us?
In most countries, including the United States and New Zealand, brain death is legally considered death. The organs may continue to function with support from machines, but if the three essential components are present – coma, absence of brainstem reflexes, and apnea – a patient is legally and clinically dead.
Bioquark wants to change that
Futuristically named “ReAnima,” the project has drawn the ire of the medical community in India, where Pastor and his team of scientists initially planned to carry out the trial in 2016. At the time, Bioquark announced that it was looking for 20 patients who would receive an injection of their own Stem Cells.
The firm had not tested the research on animals, and although each step of treatment had been tested on human patients before for conditions such as strokes and brain injuries, the results always varied.
Courting controversy
While there is some basis in science for each step in the process, the entire regimen is under major scrutiny.
One issue that has baffled many is informed consent. How can subjects in the trial consent, given that they are legally dead? Scientists and bioethicists are skeptical. Last year, bioethicist Art Caplan and neuroscientist Ariane Lewis wrote a blunt editorial denouncing the Bioquark trial as “quackery,” which Pastor rebutted with vigor.
“False hope is unfortunately created by a global medical establishment that the public sees generating $7 trillion annually, yet provides no cures for most of the chronic degenerative diseases responsible for human suffering and death. Exploratory research programs of this nature are not false hope. They are a glimmer of hope.”
Bioquark said it will begin testing on humans -- with no plans to experiment on animals -- later this year in an unspecified location in Latin America.
