The controversial clinical trial, called the ReAnima Project, is run by Revita Life Sciences and Bioquark Inc., aims to use stem cells, laser therapy, nerve stimulation and drugs to reverse brain death.
The goal of the ReAnima Project is to grow new neurons and encourage them to form connections—thus bringing the brain back to life.
“This represents the first trial of its kind and another step toward the eventual reversal of death in our lifetime,” said Dr. Ira Pastor, CEO of Bioquark.
This is not the first attempt at the trial, however. The study originally launched in Rudrapur, India, in April of last year, but did not enroll any patients. The study was shut down in November 2016 because India’s Drug Controller General had not cleared it.
However, the biotech companies have now received permission from a US institutional review board and Indian national institutes of health to begin trials. Bioquark announced it is now in the final stages of finding a new location to host trials, with a trial coming in Latin America in the next few months.
Yet the scientific community is not universally thrilled about the experiment.
For one, the study raises ethical concerns. What quality of life would a person have after coming back from the dead several months later? Would having a loved one participate in the study confer an artificially inflated hope of recovery?
For another, there is great doubt that this experiment will work. Neurologist Dr. Ariane Lewis and bioethicist Arthur Caplan write a 2016 editorial that said that the Indian version of the trial “borders on quackery” and “has no scientific foundation.”
Dr. Ed Cooper, an orthopedic surgeon who worked with neurologists on research about electrical stimulation of nerves, said that the type of electrical stimulation proposed in the clinical trial unequivocally will not work—there needs to be a functional brain stem in order for motor neurons to successfully pass through and connect with the cortex.
(Pastor stated that there is “a small nest of cells” that still functions in brain-dead patients, and so they technique would work.)
Dr. Charles Cox, a pediatric surgeon who has previously worked with the type of stem cells being used in the trial, said the trial’s protocol was “not the absolute craziest thing I’ve ever heard, but I think the probability of that working is next to zero.”
Even Pastor is not convinced of the short-term success of the project, focusing instead on the long-term. “It is a long-term vision of ours that a full recovery in such patients is a possibility, although that is not the focus of this first study—but it is a bridge to that eventuality.” He nonetheless gave the study a “pretty good chance” at succeeding.
Cox disagreed. “I think [someone reviving] would technically be a miracle. I think the pope would technically call that a miracle.”
The full trial protocol can be accessed here.
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