F

or 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.

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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, according to Pastor. Regulators shut the study down in November 2016 because, according to Science, India’s Drug Controller General hadn’t cleared it.

(Dr. Himanshu Bansal, who owns the hospital Bioquark was planning to work with in India, disputed Science’s report that the trial had stopped. He said he has been testing the protocol on patients without using Bioquark’s particular peptide mixture and said the results were being observed by an “independent observer” from a local medical college.)

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.”

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Simply quirky or mostly quackery?

No real template exists to know whether this approach might work — and it’s gotten some prominent backlash. Neurologist Dr. Ariane Lewis and bioethicist Arthur Caplan wrote in a 2016 editorial that the trial “borders on quackery,” “has no scientific foundation,” and gave families “a cruel, false hope for recovery.” (“Exploratory research programs of this nature are not false hope. They are a glimmer of hope,” Pastor responded.)

The company hasn’t tested the full, four-pronged treatment, even in animal models. Studies have evaluated the treatments singly for other conditions — stroke, coma — but brain death is a quite different proposition.

Stem cell injections to the brain or spinal cord have shown some positive results for children with brain injuries; trials using similar procedures to treat cerebral palsy and ALS have also been completed. One small, uncontrolled study of 21 stroke patients found that they recovered more mobility after they received an injection of donor stem cells into their brains.

On transcranial laser devices, the evidence is mixed. The approach has been shown to stimulate neuron growth in some animal studies. However, a high-profile Phase 3 study of one such device in humans was halted in 2014 after it showed no effect on 600 patients’ physical capabilities as they recovered from a stroke. Other trials to revive people from comas using laser therapy are underway.

The literature around electrical stimulation of the median nerve — which branches from the spinal cord down the arm and to the fingers — primarily consists of case studies. Dr. Ed Cooper wrote some of those papers, one of which described dozens of patients treated in his home state of North Carolina, including 12 who had a Glasgow Coma Score of 4 — an extremely low score on the scale. With time (and with the nerve stimulation), four of those 12 people made a “good recovery,” the paper described; others were left with minor or major disabilities after their coma.

But Cooper, an orthopedic surgeon by training who worked with neurosurgeons on the paper, said unequivocally that there is no way this technique could work on someone who is brain-dead. The technique, he said, relies on there being a functional brain stem — one of the structures that most motor neurons go through before connecting with the cortex proper. If there’s no functional brain stem, then it can’t work.

Pastor agreed — but he claimed the technique would work because there are “a small nest of cells” that still function in patients who are brain-dead.

Complicating such trials, there is no clear-cut confirmatory test for brain death — meaning a recovery in the trial might not be entirely due to the treatment. Some poisons and drugs, for instance, can make people look brain-dead. Bioquark plans to rely on local physicians in the trial’s host country to make the declaration. “We’re not doing the confirmatory work ourselves,” Pastor said, but each participant would have undergone a battery of tests considered appropriate by local authorities.

But a survey of 38 papers published over 13 years found that, if the American Academy of Neurology guidelines for brain death had been met, no brain-dead people have ever regained brain function.

Of Bioquark’s full protocol, “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 who has done research with mesenchymal stem cells — the type used in the trial — at the University of Texas Health Science Center at Houston. Cox is not involved in Bioquark’s work.

Some studies have found that cells from a part of the brain called the subventricular zone can grow in culture even after a person is declared dead, Cox said. However, it’s unlikely that the trial’s intended outcome — to have a stem cell treatment result in new neurons or connections — would actually happen. Neurons would likely struggle to survive, because blood flow to the brain is almost always lost in people who have been declared brain-dead, Cox said.

But Pastor thinks Bioquark’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.”

Cox is less optimistic. “I think [someone reviving] would technically be a miracle,” he said. “I think the pope would technically call that a miracle.”

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  • You write: “The study launched in Rudrapur, India, in April 2016 — but it never enrolled any patients”.

    That is unpossible, for according to the ever-reliable Daily Torygraph Science Editor Sarah Knapton, the study recruited its first patient in May:
    “A 27-year-old car crash victim is the first participant of a groundbreaking trial to see if it possible [sic] to regenerate the brains of clinically dead people”
    http://www.telegraph.co.uk/science/2016/05/09/trial-starts-to-bring-dead-27-year-old-car-crash-victim-back-to/

    When the people involved in a project have shown themselves to be shameless liars, why give any attention to anything that falls out of their face-holes?

  • At least they are trying to find away to help children who are brain dead my son has Anoxic brain injury and i would give anything to have him back so i believe it’s worth a try.

    • So so sorry for your son’s condition- any parent would be heartbroken. I worry that Bioquark knows the outcome will be a failure, but strive for media attention, validation and power. Unfortunately there is a difference between true hope and false hope, and I would be sad if their research took advantage of families grieving. You, and others, deserve better. God bless you.

  • I am imposing this method, unless they give life to entities unrelated to the body that once belonged. In a nutshell, the basic rule is that energy cannot be created and never lost, it evolves or moves on. Our body consists of trillions and trillions of cells and micro-organisms, which they all vibrate harmoniously so that they coexist with each other and carry out any task inside us, using electrical and chemical energy. When we die, even if some organs of the body continue to function for some time, the basic energy of what we are is leaving, the rest returns to the earth, to the environment. For example, biology does not accept death, it tells you that energy continues to exist in a different form, it moves on.

    Now if we think that a dead body that returns back to life, how will you bring back the specific energy that coexisted in this body before death and becomes the person that once was? Unless you give to the body another energy, something that was not related to the body before. They will give life if they ever do and I highly doubt, in entities unrelated to what the body/person once were.

    and do not tell me that every energy/anima is the same, otherwise the babies will not have personality on the day of birth, there would be no negative or positive energy in humans, there would not be any stupid or smart people, the world would be different.

    Unless this company has a secret agenda with cults evolved of summoning energies, otherwise I think they will fail. But even if it looks a success, it will be other entities.

    • I agree a lot with what you are saying. However, you never know until you know! I’m probably over-simplifying this but, what if when the brain “turns back on”, all the brain cells and neurons that were connected to one another before death just start functioning as they once did? It’s a long-shot, but who’s to say it won’t work like that? I mean if you completely halt decomposition of the body, then all the connections should still be intact right? Anyhow, I doubt science will achieve something like this for a hundred years at least because we haven’t even found a cure for cancer yet, which sounds like a cake-walk when you compare it to reversing death.

    • “biology does not accept death, it tells you that energy exists in a different form; it moves on… Unless you have given the (dead) body another energy, unrelated to the body it cannot become the same body/person it was before.”

      Your comment quite nicely refutes the core problem of bringing a person back to life, without even wondering if Bioquark members read Frankenstein or watched Flatliners as an ethical “what not to do”. You also explain nicely the scientific theology of Jesus Christ’s resurrection. Our finite qualities of life and death can be a celebration acknowledging the intrinsically inhuman quality of God.

  • The flawless cycle of growing old from birth onwards is so beautiful & so organised the it should not be disturbed. Make place for younger generation to take over. Leave this world happily never to come back.

  • The world needs more people with the courage to dare more like this company is doing. I’d gladly volunteer whenever my time comes, although cryonics attracts me more.

  • This is controversial to me in that even if it does succeed, the person who “wakes up” won’t be the same person that their family loved. What they’re trying to do is “inject” a new person into a brain dead body, because brain death means all brain activity has stopped… meaning most if not all memories have been lost. So anyone coming back from this procedure is going to essentially be an infant in an adult body, and I’d question how much brain function they’d ever fully have.

    • Are we ever the same persome we ever have been? Are you the same person you were yestrerday or two minutes ago? The notion of the “same person” has no logical or scientific basis. We are always in a transient condition.

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