Rudrapur, Uttrakhand, India — July 02, 2017
Revita Life Sciences, (http://revitalife.co.in) a biotechnology company focused on translational regenerative therapeutic applications, has announced that it is continuing to advance their novel, multi-modality clinical intervention in the state of brain death in humans.
“We have proactively continued to advance our multi-modality protocol, as an extended treatment before extubation, in an attempt to reverse the state of brain death” said Mr.Pranjal Agrawal, CEO Revita Life Sciences. “This treatment approach has yielded some very encouraging initial outcome signs, ranging from minor observations on blood pressure changes with response to painful stimuli, to eye opening and finger movements, with corresponding transient to permanent reversal changes in EEG patterns.”
This first exploratory study, entitled “Non-randomized, Open-labelled, Interventional, Single Group, and Proof of Concept Study with Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury” is ongoing at Anupam Hospital, Rudrapur, Uttrakhand. The intervention primarily involves intrathecal administration of minimal manipulated (processed at point of care) autologous stem cells derived from patient’s fat and bone marrow twice a week.
This study was inappropriately removed from the Indian Council of Medical Research (ICMR) database. ICMR has no regulatory oversight on such research in India.
The Central Drugs Standard Control Organization (CDSCO), Drug Controller General of India, had no objection to the program progressing. Regulatory approval as needed for new drugs, is currently not required when research is conducted on the recently deceased, although IRB and family consent is definitely required. CDSCO, the regulator of such studies, clearly states that “no regulatory requirements are needed for any study with minimal manipulated autologous stem cells in brain death subjects”.
Death is defined as the termination of all biological functions that sustain a living organism. Brain death, the complete and irreversible loss of brain function (including involuntary activity necessary to sustain life) as defined in the 1968 report of the Ad Hoc Committee of the Harvard Medical School, is the legal definition of human death in most countries around the world. Either directly through trauma, or indirectly through secondary disease indications, brain death is the final pathological state that over 60 million people globally transfer through each year.
“We are in process of publishing our initial retrospective results, as well ongoing early results, in a peer reviewed journal. These initial findings will prove invaluable to the future evolution of the program, as well as in progressing the development multi-modality regenerative therapeutics for the full range of the severe disorders of consciousness, including coma, PVS, the minimally conscious state, and a range of other degenerative CNS conditions in humans,” said Dr. Himanshu Bansal, Chief Scientific Officer, Revita Life Sciences and Director of Mother Cell.
With the maturation of the tools of medical science in the 21st century, especially cell therapies and regenerative medicines, tissues once considered irretrievable, may finally be able to be revived or rejuvenated. Hence many scientists believe that brain death, as presently defined, may one day be reversed. While the very long term goal is to find a solution for “re-infusing life”, the short term purpose of these types of studies is much less dramatic, which is to confirm if the current definition of brain irreversibility still holds true. There have been many anecdotal reports of brain death reversal across the world over the past decades in the scientific literature. Studies of this nature serve to verify and establish this very fact in a scientific and controlled manner. It will also one day give a fair chance to individuals, who are declared brain dead, especially after trauma.
About Revita Life Sciences
Revita Life Sciences is a biotechnology company focused on the development of stem cell therapies and regenerative medicine interventions that target areas of significant unmet medical need. Revita is led by Dr. Himanshu Bansal MD, who has spent over two decades developing novel MRI based classifications of spinal cord injuries as well as comprehensive treatment protocols with autologous tissues including bone marrow stem cells, Dural nerve grafts, nasal olfactory tissues, and omental transposition.
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I have spent the last 30 years in various aspects of the biopharmaceutical industry, which for the most part has been a very rewarding experience.
However, during this time period, having been immersed many different components of therapeutic development and commercialization, one thing has always bothered me: a wide array of promising research never makes it off the bench to see the translational light of day, and gets lost in the historical scientific archives.
I always believed that scientific progress happened in a very linear narrative, with each new discovery supporting the next, resulting ultimately in an eventual stairway of scientific enlightenment.
What the reality turned out to be was much more of a fragmented, research “evolutionary tree”, with dozens of potential pathways, only very few branches of which ever resulted in scientific maturity, and not always the most fruitful ones by any means.
The premature extinction of these promising discovery pathways were the result of a variety of factors, including, but not limited to, funding priorities, competing industrial interests, “out of vogue” concepts, lack of intellectual properties, non-existent regulatory models, conflicted legislative initiatives, and even religious implications.
In 2016, as in previous years, we continue to see these “valleys of death” swallow up pathways of scientific possibility, with few popular segments attracting the majority of attention and support.
The preponderance of resources focused on the somatic mutation model of carcinogenesis, despite an endless range of research highlighting that the disease is extremely heterogenic and rarely ever follows such a clonal model, is one example that continues to be inappropriately manifested in the oncology system, decades into the “war on cancer”.
On a similar plane, the jettisoning of most studies of the biophysical aspects of human genetics, despite the gross incompleteness offered by the central dogma to explain higher biological form and function, is another example that has become all too pervasive in the research community.
And then there are the areas of human consciousness, memory, and information processing / storage, where in many ways we are still operating in the dark ages, with materialists and dualists battling it out for centuries.
One topic that I have written quite a bit about is that of death, specifically that of the death of the human brain — http://www.singularityweblog.com/is-death-reversible/
While I am a staunch supporter and advocate of the life-extension / anti-aging movement, I am equally vocal about our need to develop technologies, products, and services that can actually reverse our ultimate transition between the living and dead states, a transition that occurs annually for 60 million humans around the globe.
Death, however, is unfortunately seen by many as a natural, biological progression for human beings, and in many circles, deemed an unnecessary area of scientific research and exploration.
I beg to differ.
Far too often, death arrives too early and too unexpectedly for many of us and our loved ones. And the best modern medicine has to offer today is “Sorry. There is nothing else we can do.”
But what if there was?
There are a variety of species across the natural world that are capable of regenerating and repairing themselves from forms of severe CNS damage that bring them to the transitional grey zone between life and death. Along the evolutionary timeline however, this ability gradually disappeared hundreds of millions of years ago and does not manifest in higher species.
Now, in the 21st century, with the convergence of the disciplines of regenerative biology, cognitive neuroscience, and clinical resuscitation, we may finally be poised to take back these capabilities for humans.
Over the years, clinical science has focused heavily on preventing such life and death transitions and made some initial progress with suspended animation technologies, such as therapeutic hypothermia. But once we transition through the brain death window, currently defined by the medical establishment as “irreversible” (per the 1968 Ad Hoc Committee of the Harvard Medical School definition), we are technically no longer alive.
To add insult to injury, a human can be declared dead, even while our bodies can still circulate blood, digest food, excrete waste, balance hormones, grow, sexually mature, heal wounds, spike a fever, and gestate and deliver a baby. It is even acknowledged by thought leaders that recently brain dead humans still may have residual blood flow and electrical nests of activity in their brains, just not enough to allow for an integrated functioning of the organism as a whole.
Several prominent cases in the media over the past few years have further served to highlight the current situation, as well as the substantial anatomical and functional differences between the state known as brain death, and other severe disorders of consciousness, such as coma, and the vegetative and minimally conscious states.
It is now time to take the necessary steps to provide new possibilities of hope, in order to counter the pain, sorrow, and grief that is all too pervasive in the world when we experience a loved one’s unexpected or untimely death, due to lesions which might be potentially reversible with the application of promising neuro-regeneration and neuro-reanimation technologies and therapies.
It is time to undertake the required research, based on 2016 technological knowledge, in order to bring about such transformational change.
My name is Ira S. Pastor and I am the CEO of the biotechnology company Bioquark Inc.
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