– 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, with very enthusiastic early results which will change the concept of brain death and probably the concept of irreversible cell death.
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. Adjuvants like Median nerve stimulation (MNS) daily for eight hours to stimulate reticular activating system for arousa.. Transcranial laser stimulation twice a day for one hour stimulates mitochondria hence ATP production which provides energy to compromised cells.
This study was inappropriately removed from the Indian Council of Medical Research (ICMR) database. ICMR has no regulatory mandate on such research in India, and the Central Drugs Standard Control Organization (CDSCO) had no objection to the program progressing. The study has never been blocked by any regulatory agency around the world.
Regulatory approval as needed for new drugs is currently not required when research is conducted on with autologous cells on the recently deceased, although IRB and family consent is definitely required. Indian FDA, 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 as 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 lifesciences and Director Mother cell.
With the advancement in medical science especially cell therapy cells previously considered irretrievable can be revived or rejuvenated hence various scientist believe that brain death as presently defined can be resuscitated .While the very long term goal is to find a solution for “infusing life”, the short term purpose of these types of studies is very less dramatic . In fact it is to confirm definition of brain death still holds good with so many advancements in intensive care and cell biology. There are many anecdotal reports of brain death reversal across the world. This study is to establish this very fact in a scientific and controlled manner. It will also give fair chance to young individuals who are declared brain death especially after trauma.
Notes to Editor
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 MS, 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.