Resurrected: A Controversial Trial to Bring the Dead Back to Life
For any given medical problem, it seems, there’s a research team trying to use stem cells to find a solution. In clinical trials to treat everything from diabetes to macular degeneration to ALS, researchers are injecting the cells in efforts to cure patients.
But in one study expected to launch later this year, scientists hope to use stem cells in a new, highly controversial way — to reverse death.
The idea of the trial, run by Philadelphia-based Bioquark, is to inject stem cells into the spinal cords of people 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 ultimate goal: to grow new neurons and spur them to connect to each other, and thereby 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. Hence why we have to take a different approach,” said Ira Pastor, CEO of Bioquark.
But the scientific literature — scarce as it is — seems to show that even several magic bullets are unlikely to accomplish what Bioquark hopes it will.
This isn’t the first start for the trial. The study launched in Rudrapur, India, in April 2016 — but it never enrolled any patients. Regulators shut the study down in November 2016 because, according to Science, India’s Drug Controller General hadn’t cleared it.
Now, Pastor said, the company is in the final stages of finding a new location to host trials. The company will announce a trial in Latin America in coming months, Pastor told STAT.
If that trial mirrors the protocol for the halted Indian one, it’ll aim to enroll 20 patients who’ll receive a barrage of treatments. First there’s the injection of stem cells isolated from the individual’s own fat or blood. Second, there’s a peptide formula injected into the spinal cord, purported to help nurture new neurons’ growth. (The company has tested the same concoction, called BQ-A, in animal models of melanoma, traumatic brain injuries, and skin wrinkling.) Third, there’s a regimen of nerve stimulation and laser therapy over 15 days to spur the neurons to form connections. Researchers will look to behavior and EEG for signs that the treatment is working.
But the process is fraught with questions. How do researchers complete trial paperwork when the person participating is, legally, dead? (In the United States, state laws most often define death as the irreversible loss of heart and lung or brain function.) If the person did regain brain activity, what kind of functional abilities would he or she have? Are families getting their hopes up for an incredibly long-shot cure?
Answers to most of those questions are still far off. “Of course, many folks are asking the ‘what comes next?’ question,” Pastor acknowledged. “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.”
