Controversial research and trials aim to reverse clinical brain death and bring people back from irreversible coma.

Philadelphia-based biotech company Bioquark is preparing to run trials in Latin America of a controversial new treatment to restore brain function in people with brain damage.

The procedure consists of several different parts. One of which uses a patient’s own stem cells to regrow dead brain tissue. The procedure also includes a peptide injection into the spine, laser therapy on the brain, and nerve stimulation.

“The first thing we are really looking at is how do we make that new tissue, along the lines of how it is done in nature,” Ira Pastor, CEO of Bioquark, told Healthline.

Doctors and staff measure the brain activity and physical signs of the patient to establish whether or not there has been an improvement.

While the research has often been labeled as an attempt toraise the dead,” Pastor said that there are actually significant limitations to the scope of what they are trying to accomplish.

“We are only focusing on what we refer to as the gray zone that exists between [a] deep coma and so-called irreversible coma, which is the definition of brain death, and transitioning the subject back through that area,” said Pastor.

Measure of an individual’s state of coma or unconsciousness typically utilizes the Glasgow Coma Scale, an indicator of the severity based on verbal and physiological responses.

Bioquark’s aim is essentially to be able to take individuals from a state of irreversible coma to, potentially, one in which they are showing higher brain functioning and physiological response.

He said that the treatment is not intended for individuals with catastrophic injuries, or those with chronic diseases, such as metastatic cancer.

Brain death is a relatively new concept in medicine and law, and still varies largely from one country to the next. Unlike clinical death, as defined by the stopping of certain biological functions — such as breathing and heart rate — brain death is a state in which an individual may still be physically alive but with little or no cognitive ability.

The concept of brain death is attributed to a 1968 paper from Harvard University that sought to “define irreversible coma as a new criterion for death.” Since then, legislation such as the Uniform Determination of Death Act, has sought to create a unified framework for how death is diagnosed, including brain death.

The implications of Bioquark’s research potentially altering or muddying an already complex definition of death are profound. “This study deepens the ambiguity of the validity of the definition of death,” Kerry Bowman, PhD, a bioethicist at the University of Toronto, told Healthline.

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The procedure has also proved wildly controversial for ethical and medical reasons.

Firstly, the research falls under the classification of “living cadaver research,” which Pastor describes as, “The ability to use a recently deceased individual who is still on life support for medical research purposes.”

Pastor argued previously that living cadaver research has been carried out ethically for a variety of reasons in the Unites States. Nonetheless, it remains a sensitive subject.

There are those in the medical community who criticize Bioquark because there simply isn’t any medical research to support its work. One meta study published in the journal Neurology in 2010, concluded that from 1995 onward, “There are no published reports of recovery of neurologic function after a diagnosis of brain death.”

Pastor contests this, citing sporadic cases challenging that conclusion.

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Bowman said the two major concerns surrounding Bioquark’s work are family grief and patient consent.

In the first case, he said, the procedure “could create a situation where [the family] believes that their brain-dead or close to brain-dead loved one has a chance for survival, and that the medical establishments are blocking them from pursuing that chance.”

“I think that really could be very difficult in terms of complicating grief.”

The second issue, consent, is even more contentious. Who signs off on the procedure if the patient doesn’t have the capacity to say “Yes” or “No”?

“Clearly this is a case where the subject cannot consent,” said Pastor. “The informed consent documents that we have put together are really family centric.”

“There is a line of reasons why a family might want to come down this path, but ultimately it’s their decision.”

Others disagree that consent in this situation is as clear as Pastor makes it.

Bowman said that the potential risk of such a procedure is so high that the consent must come directly from the patient.

“The ranges of outcomes — I see physical impairment and neurological impairment as almost a certainty even if there is success — that I just don’t think you could have a substituted consent.”

Some have suggested that consent could be coerced under the proposition of bringing back a loved one.

Pastor, however, is confident in Bioquark’s proceedings.

“Of the multitude of different types of bioethical arguments or questions we get, I think we’re comfortable with that family-centric, informed consent approach,” he said.

Whether or not Bioquark ultimately succeeds, their upcoming trials will undoubtedly have a profound impact on the concept of death.

Bowman, while skeptical of Bioquark’s research from a medical perspective, is open to challenging the established notion of brain death.

“There are places in the world that are much more hesitant about accepting brain death as truly death,” he said. “We constructed this as a definition of death, but we can also deconstruct a definition that we created ourselves.”

As to the claim that Pastor and Bioquark are offering “false hope” to those that are already vulnerable and suffering, he remains defiant.

“Exploratory research programs of this nature are not false hope. They are a glimmer of hope.”

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