Patient’s own stem cells along with other modalities being tried to reverse brain death
A team of doctors and scientists from India and USA led by Dr Himanshu Bansal as principal investigator are working on an ambitious project to infuse life into those deemed brain dead. The multi-modality approach is to reverse brain death that could be the path to a medical breakthrough
A first-of-its kind study aims to provide a proof-of-concept, possibility of reversal of brain death in 20 patients in India. The project will be housed at Anupam Hospital, Rudrapur, Uttarakhand and couple of other centres in Delhi in the first phase.
This study will try to look for a possibility to reverse brain death in traumatic brain injury patients and help them lead a normal life. “If successful the study will change the way we define brain death and will be a new breakthrough in medical science”, said Bansal.
The study will start recruiting patients who are declared clinically dead from accident.
The study is a collaboration between the US based biotech company Bioquark Inc and Indian biotech company Revita Life Sciences and Anupam Hospital. The study will enroll 20 patients and will be conducted for a year between April 2016-2017 at Anupam Hospital, Utrakhand.
Dr Himnshu Bansal has been granted clearance by the regulatory body to enroll 20 patients who have been declared clinically dead from traumatic brain injury not willing for organ donation. These patients are kept alive by using life support machines, which means that their brain has stopped working and they cannot breathe or circulate blood on their own. The study will recruit young patients declared brain dead after having head injury. “These patients should have diffuse axonal injury and not localised injury as localised injury has difference challenge,” said Bansal. During the clinical trials scientists will use a combination of therapies to test whether functions of parts of the patient’s nervous system can be brought back.
The standard criteria of brain death will be used to diagnose and declare brain death. Once diagnosed all these different modalities will be offered as early as possible preferably between 8 -24 hrs after brain death.
The first stage of the trial named ‘First In Human brain death reversal project ’ will be conducted at Anupam Hospital in Rudrapur, Uttarakhand in India.
“This project is Multi-Modality Approach to reverse brain death. We are trying to reverse brain death in this project while treating patients with laser, with regular infusion of stem cells and stimulation along with bioactive peptides.
By using multi-modality approach (intra-thecal bioactive peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as adjuvants) the study will determine if clinically dead patients can be brought back to life
These different modalities will trigger biochemical metabolic bioelectric pathways within the neurons.
The use of stem cell therapy is very promising in patients with persistent vegetative state including Brain dead subjects. Patients own stem cells from the bone marrow and adipose derived stem cells will be utilised . Approximately 240 cc of bone marrow and 100 cc of fat will be processed with point of care approach in lab to extract high quality and approx 300 million stem cells .
Peptides and m RNAs: The solution contains highly active protein molecules and mRNAs. They have very high capacity to reprogramme, regenerate and repair cells.
Transcranial laser application with direct irradiation of the human brain is done with highly focused infrared lasers due to the ability of infrared light to penetrate bones and bring the light energy into the targeted brain areas.Intravenous blood irradiation is used to stimulate the functional activity of the hypothalamus and limbic system.
The median nerve stimulation at specific frequency and order through , ascending erticular activating system (RAS), intralaminar and parafascicular nuclei of the thalamus (responsible for maintaining and initiating wakefulness, may bring about the desired state of arousal.
The possible benefit of participating in this investigation is that peptides, stem cells and adjuvants may assist neural repair by stimulating synthesis of growth factors, serving as chaperone or nurse cells to injured tissues, and/or by facilitating neurogenesis in brain dead
These subjects will be monitored daily for any sign of brain activity by clinically as well electrophysiologically. We will be conducting safety assessments of procedure by CSF /MRI examination as well. This will give input for future intervention as well.
Dr Bansal further said, “We have got some very encouraging results in patients in coma, persistent vegetative state. We have even offered the same protocol to a couple of brain dead subjects in Gulf and Europe. We have been able to revert those terminal coma impending brain dead subjects into useful human beings . the same protocol with more intensity has brough back couple of brain dead subjects into a stage of consistent vegetative state as of now. So encouraged by those results, we are now trying to create a definitive study in 20 subjects and prove that the brain death is reversible. This will open the door for future research and show that all damage in the body is reversible if treated appropriately
Dr Himanshu Bansal, Principal Investigator of the Indo-US Project is involved in various trial involving stem cells in neurodegenertaive disorders for last 10 years. he has been collaborating with various centres in India Europe and the US since 2005”.
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