Wednesday, May 4, 2016

Lazarus trial hopes to REVERSE death: 'Reanimation' firm gets ethical approval to bring brain-dead people back to life

Lazarus trial hopes to REVERSE death: 'Reanimation' firm gets ethical approval to bring brain-dead people back to life


  • Brain death is the 'complete irreversible loss of brain function'
  • This is the definition of death and is as final as cardiac death
  • But a company in the US is working on ways to reverse brain death 

  • The techniques will be put to test in a clinical trial starting next year


To be declared officially dead in the majority of countries, you have to experience complete and irreversible loss of brain function, or 'brain death.'

And although this sounds final and absolute, a company in the US believes it doesn't have to be.

Bioquark claims death may not be 'irreversible' and we have reached a point to 'push the envelope' and test if this is really the case.

And now the project has gained ethical approval from regulatory bodies for the first stage in what has been dubbed 'Lazarus trial'.
The irreversible loss of brain function, or 'brain death', is the legal definition of human death in most countries around the world. But one company believes brain death may no longer be the end of the line. The project has gained ethical approval from regulatory bodies for the first stage in what has been dubbed 'Lazarus trial'
The irreversible loss of brain function, or 'brain death', is the legal definition of human death in most countries around the world. But one company believes brain death may no longer be the end of the line. The project has gained ethical approval from regulatory bodies for the first stage in what has been dubbed 'Lazarus trial'

The project now plans to recruit a small number of patients, who will have been declared clinically dead from brain injury.
It has been dubbed Lazarus after Saint Lazarus who is said in the Bible to have been brought back to life by Jesus four days after his death. 

'We are repeatedly told through the medical establishment that brain death is "irreversible" and should be considered the end of the line,' Ira Pastor, boss of Bioquark said.

WHAT IS BRAIN DEATH? 

The complete and irreversible loss of brain function, or 'brain death', is the legal definition of human death in most countries around the world.
In the UK and the US, among other countries, a person is confirmed as being dead when their brain stem function is permanently lost. 
Being brain dead is widely accepted to be just as final as cardiac death. 
'Or is it? Have we come to a technological point where we are able to 'push the envelope' to see if this is truly the case?

'While it is true that human beings lack substantial regenerative capabilities in the central nervous system (CNS), many non-human species, such as amphibians, planarians, and certain fish, can repair, regenerate and remodel substantial portions of their brain and brain stem even after critical life-threatening trauma,' Mr Pastor said. 

Confirming death used to be straightforward, according to the NHS. It was said to occur when the heart stopped beating and a person was unresponsive and no longer breathing. 

The lack of oxygen, which occurred as a result of no blood flow, quickly led to the permanent loss of brain stem function.
The project now plans to recruit a small number of patients, who will have been declared clinically dead from brain injury. It has been dubbed Lazarus after the Bible's Saint Lazarus who is said to have been brought back to life by Jesus four days after his death (illustrated)
The project now plans to recruit a small number of patients, who will have been declared clinically dead from brain injury. It has been dubbed Lazarus after the Bible's Saint Lazarus who is said to have been brought back to life by Jesus four days after his death (illustrated)

BIBLICAL MIRACLE OF LAZARUS 

The project has been dubbed Lazarus after Saint Lazarus who is said in the Bible to have been brought back to life by Jesus four days after his death. 
The story of the Raising of Lazarus is found in the Gospel of John.
Lazarus is described as a follower of Jesus, who lives in the town of Bethany near Jerusalem.
A similar resurrection story is in the Secret Gospel of Mark, although the man is not named. 

But now confirming death is more complicated, because it's possible to keep the heart beating after the brain stem has permanently stopped functioning. 

This can be done by keeping a person on a ventilator, which allows the body and heart to be artificially oxygenated, for example.

In the UK and the US, among other countries, a person is confirmed as being dead when their brain stem function is permanently lost.  Being brain dead is widely accepted to be just as final as cardiac death. 

Mr Pastor, along with Dr Sergei Paylian, the founder of Bioquark, is on the advisory board of a project called ReAnima. 

The ReAnima project website describes the project as 'exploring the potential of cutting edge biomedical technology for human neuro-regeneration and neuro-reanimation.'
'The mission of the ReAnima Project is to focus on clinical research in the state of brain death, or irreversible coma, in subjects who have recently met the Uniform Determination of Death Act criteria, but who are still on cardio-pulmonary or trophic support - a classification in many countries around the world known as a "living cadaver"' Mr Pastor told MailOnline.
A salamander (pictured) is part of a group of amphibians that can repair, regenerate and remodel substantial portions of their brain and brain stem even after critical life-threatening trauma. A study in 2007 showed that after a portion of their brains were removed, the animals managed to grow it back
A salamander (pictured) is part of a group of amphibians that can repair, regenerate and remodel substantial portions of their brain and brain stem even after critical life-threatening trauma. A study in 2007 showed that after a portion of their brains were removed, the animals managed to grow it back

He said the project has an 'ultimate goal of inducing epimorphic, intercalary, regenerative and remodeling events that can begin to restore CNS form and function.'

Mr Pastor added that 'epimorphic' in this context refers to the ability of cells to erase their history and re-start life again.

THE REANIMA PROJECT 

The ReAnima project website describes the project as 'exploring the potential of cutting edge biomedical technology for human neuro-regeneration and neuro-reanimation.'
'The mission of the ReAnima Project is to focus on clinical research in the state of brain death, or irreversible coma, in subjects who have recently met the Uniform Determination of Death Act criteria, but who are still on cardio-pulmonary or trophic support - a classification in many countries around the world known as a "living cadaver"' Mr Pastor, one of the project's advisors, told MailOnline. 
He said the project has an 'ultimate goal of inducing epimorphic, intercalary, regenerative and remodeling events that can begin to restore CNS form and function.' 

'To undertake such a complex initiative, we are combining certain biologic regenerative tools, with other existing medical devices typically used for stimulation of patients with other severe disorders of consciousness,' he explained.

'We just received Institutional Review Board (IRB) approval for our first 20 subjects and we hope to start recruiting patients immediately.'

The first stage, named 'First In Human Neuro-Regeneration & Neuro-Reanimation' will be a non-randomised, single group 'proof of concept' study. 

The team will examine individuals aged 15-65 declared brain dead from a traumatic brain injury using MRI scans, in order to look for possible signs of brain death reversal. 

They will use techniques involving peptides, lasers, stem cells and median nerve stimulation to try and bring about the reversal of brain death, whilst monitoring the patients using MRI scans. 

'We hope to see results within the first two to three months,' he said.

A positive initial result would be 'an epimorphic event upwards at the intersection of the upper spinal cord, the highest part still "alive" in a living cadaver subject, and the lowest region of the brain stem, the lowest area of brain stem death and the source of independent breathing / and subsequently heart beat.
The team will examine individuals aged 15-65 declared brain dead from a traumatic brain injury using MRI scans, in order to look for possible signs of brain death reversal. False colour of an MRI scan of a human brain shown. They will use techniques involving peptides, lasers, stem cells and median nerve stimulation
The team will examine individuals aged 15-65 declared brain dead from a traumatic brain injury using MRI scans, in order to look for possible signs of brain death reversal. False colour of an MRI scan of a human brain shown. They will use techniques involving peptides, lasers, stem cells and median nerve stimulation

But this research is likely to be years from any stage where it could be applied widely.

A non-randomised single group study is far from the randomised control trial, which is seen as the gold standard of clinical trials.

UNDERSTANDING CLINICAL TRIALS 

All clinical trials of new medicines go through a series of phases to test whether the medicines are safe and whether they work.
A non-randomised single group study is far from the randomised control trial, which is seen as the gold standard of clinical trials.
In a randomised control trial (RTC) participants are randomly assigned to a study group.
This means they have an equal probability of being assigned to any group - either receiving the treatment or the 'control' group receiving a placebo.
'While there have been numerous demonstrations in recent years that the human brain and nervous system may not be as fixed and irreparable as is typically assumed, the idea that brain death could be easily reversed seems very far fetched, given our current abilities and understanding of neuroscience,' Dr Dean Burnett, neuroscientist at the Cardiff University Centre For Medical Education told MailOnline.

'The brain is a very demanding and vastly complex organ, but this also means it's very fragile.'

He said even a brief interruption of blood supply could cause permanent damage to the active parts of the brain.

'It's true some brain areas may be more durable, or have a more reliable blood supply, but a person, despite the myth, needs all of their brain working. It's not just the brain cells that are important, it's the incredibly intricate ways they're connected to many other areas.

'Saving individual parts might be helpful but it's a long way from resurrecting a whole working brain, in a functional, undamaged state. There's been nothing to suggest we're even close to that point yet.'

But Mr Pastor thinks the trials could lead to results by as early as next year. 

'We believe we are quite close to a point in time where the delineation between coma, and irreversible coma or brain death will become "blurred" and hope to have such promising insights by 2017,' Pastor told MailOnline.

'Because 50,000 of the 150,000 people who die daily do not die from aging, but from various acute traumas that lead rapidly to brain death, we think even this modest dynamic will have a major impact.'


Read more: http://www.dailymail.co.uk/sciencetech/article-3572735/Lazarus-trial-hopes-REVERSE-death-Reanimation-firm-gets-ethical-approval-bring-brain-dead-people-life.html#ixzz47jsr98g7

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