In what seems like the plot from a bad horror movie, officials at a Philadelphia-based company called Bioquark have announced that they are close to starting a clinical trial to determine whether a series of procedures administered to clinically dead people can bring them back to life, according to an article posted on the STAT website.
The idea of the trial is to inject stem cells into the spinal cords of subjects who have been declared clinically brain-dead. The subjects will also receive an injected protein blend, electrical nerve stimulation, and laser therapy directed at the brain. The protocol’s ultimate goal is to grow new neurons and spur them to connect to each other, thereby bringing the brain back to life, according to Bioquark.
This isn’t the first start for the trial, the STAT article notes. A previous study was launched in India in April 2016—but it never enrolled any patients. Regulators shut the trial down in November 2016 because, according to the journal Science, India’s Drug Controller General hadn’t cleared it.
Bioquark’s CEO, Ira Pastor, told STAT that his company plans to announce a new trial in Latin America in coming months.
If the protocol of that study is similar to the design of the previous one, clinically dead subjects will receive a barrage of treatments. First, there’s the injection of stem cells isolated from the individual’s own fat or blood. Second, a peptide formula is injected into the spinal cord––purportedly to help nurture the growth of new neurons. Third, the subject will undergo a 15-day regimen of nerve stimulation and laser therapy to spur the neurons to form connections.
But the process is fraught with questions, STAT says. For example, how do researchers complete trial paperwork when the person participating in the study is legally dead? If the person did regain brain activity, what kind of functional abilities would he or she have?
Bioquark concedes that it has never tested its four-stage procedure, even in animals.
The unusual approach has gotten some prominent backlash, according to the STAT article. Neurologist Dr. Ariane Lewis and bioethicist Arthur Caplan wrote in a 2016 editorial in Critical Care that the initial trial bordered on “quackery,” had “no scientific foundation,” and gave families “a cruel, false hope for recovery.”
“It’s not the absolute craziest thing I’ve ever heard, but I think the probability of that working is next to zero,” said Dr. Charles Cox, a pediatric surgeon at the University of Texas Health Science Center at Houston.
But Pastor thinks his company’s protocol will work. “I give us a pretty good chance,” he said. “I just think it’s a matter of putting it all together and getting the right people and the right minds on it.”
Source: STAT; June 1, 2017.