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Disclaimer: At NeuroGen BSI, autologous bone marrow tissue, after minimal manipulation, is grafted by medical practioners as part of routine procedure within the hospital in the same surgical sitting. According to the directives of the Ministry of Health and Family Welfare issued under section 33P of the Drugs and Cosmetics Act,1940 this procedure does not involve use of stem cells/ stem cell derived product.
Traumatic Brain Injury is one of the most common causes of death and disability worldwide. It occurs when a bump, blow, jolt, or other head injury causes damage to the brain. The severity of injury varies from mild to severe depending on the cause of injury.
It can lead to neurological damage, and may be associated with chronic headaches, seizures, cognitive dysfunction, sleep disorders, memory deficits, along with behavioral problems and depression which greatly impacts the daily functioning of the patient.
Causes of Traumatic Brain Injury are very diverse. It most commonly results from falls, vehicle accidents, sports accidents and gunshot wound.
Vehicular accidents
Accidents involving vehicles with pedestrians involvement, is a common cause of traumatic brain injury.
Falls
Falls from a high bed or a ladder, down the stairs, in the bath and other falls from a height are the most common cause of traumatic brain injury overall, particularly in older adults and young children.
Firearm and other explosive blasts and other combat injuries
Gunshot injuries and explosive blasts are a common cause of traumatic brain injury in active-duty military personnel. In the events of explosive blasts, it is speculated that the pressure wave passing through the brain significantly disrupts brain function.
Physical assault
Domestic violence, child abuse and other physical assaults are common causes. ‘Shaken baby syndrome’ in infants is a traumatic brain injury caused by violent shaking.
Sports injuries
A number of sports, including soccer, boxing, football, baseball, lacrosse, skateboarding, hockey, and other high-impact or extreme sports can cause traumatic brain injuries. These are particularly common in youth.
Traumatic brain injury also results from penetrating wounds, severe blows to the head with shrapnel or debris, and falls or bodily collisions with objects following a blast.
Traumatic Brain Injury can have wide-ranging physical and psychological effects. Some signs or symptoms may appear immediately after the traumatic event, while others may appear days or weeks later. Individuals suffering from mild traumatic injury may show loss of consciousness, headache, nausea or vomiting, fatigue and loss of balance. They may also exhibit sensory and cognitive issues such as blurred vision, ringing in the ears, a bad taste in the mouth, changes in the ability to smell, memory loss, concentration problems and mood swings.
Moderate to severe traumatic brain injuries can include any of the signs and symptoms of mild injury, as well as the following symptoms that may appear within the first hours to days after a Traumatic Brain Injury:
Convulsions and seizures
Dilation of one or both pupils
Weakness and numbness in the toes and fingers
Loss of coordination
Lack of movements of limbs
Agitation, combativeness or other unusual behaviour
Changes in speech clarity and comprehension
Difficulty in swallowing and breathing
Coma
Abnormal posturing of limbs
Tightness in limbs
The recovery in TBI depends on the degree of injury/damage to the brain. In addition, parts of the brain injured may also play as a deciding factor in prognosis of the patients.
Emergency care focuses on stabilizing the patient and ensuring that the patient gets adequate oxygen and blood supply, maintains blood pressure and any further secondary injury is prevented. Surgery may also be required to remove blood clots and repair skull fractures. Medications too, are used to treat the symptoms associated with Traumatic Brain Injury.
Rehabilitation including physiotherapy, occupational therapy, speech and language therapy, psychological intervention may be required either for a short duration or throughout the life depending on severity of injury. These treatment strategies may help in efficient management of the symptoms post injury and recover lost functions.
Despite advances in the medical field with respect to treatment of traumatic brain injury, a significant number of patients are left with neurological deficits for which there is no treatment so far. Regenerative medicine has evolved as a potential treatment which addresses the neurological damage in traumatic brain injury when administered in combination with other conventional treatments. It helps in restoring lost functions by neuroregenerative and neuroprotective mechanisms.
Regenerative Medicine involves transplantation of cell which migrate to the damaged brain areas and carry out the repair process directly or indirectly. These cells on transplantation, multiply, differentiate and directly replace the dead or damaged brain cells. They also indirectly carry out repair and restoration via paracrine mechanisms. They release various cytokines and growth factors which stimulate the endogenous cells and stop further damage of brain cells. They promote angiogenesis (development of new blood vessels) which help in increased supply of blood and oxygen to the brain and initiate sprouting of new axons. These mechanisms together re-establish the neuronal networks and help in formation of new communication networks which further lead to restoration of lost functions in Traumatic Brain Injury.
At NeuroGen BSI, we have treated over a 100 cases of Traumatic Brain Injury with intrathecal transplantation of autologous bone marrow mononuclear cells combined with neurorehabilitation. Overall improvement was observed in 94% of these patients.
Significant improvements were seen in higher mental functions, posture, upper limb activity, lower limb activity, trunk control, sitting balance, standing balance, coordination, oromotor skills, ambulation and Activities of Daily Living (ADLs). The progress of these patients was also measured on various scales such as Functional Independence Measure (FIM), Disability rating Scale (DRS), SF-8 questionnaire which showed improved scores after regenerative medicine.
PET-CT Brain Scans
PET CT scan brain was also used to monitor the effect of regenerative medicine at cellular level. Improvement in brain metabolism was recorded on comparing the PET CT scans performed before and after regenerative medicine. The improvements in clinical symptoms correlated with the areas showing improved metabolic functions on the PET CT scan.
Pre regenerative medicine PET-CT scans showing blue areas which are areas of reduced metabolism or damage.
Post regenerative medicine PET-CT scan showing reduction in blue areas which have been replaced by green areas indicating improvement in metabolism/function
PET CT Scan of the brain before regenerative medicine shows reduced metabolism in the left posterior cingulate cortex, left Precuneus, left superior parietal cortex and cerebellum.
PET CT Scan 6 months after regenerative medicine shows reduced metabolism in the left posterior cingulate cortex, left percuneus, left superior parietal cortex and cerebellum.
Traumatic brain injury (TBI) occurs when a sudden trauma, often a blow or jolt to the head, causes damage to the brain. The severity of TBI can range from mild (a concussion) to severe (coma).
The recovery in TBI depends on the degree of injury/damage to the brain. In addition, parts of the brain injured may also play as a deciding factor in prognosis of the patients.
Long-term neurological sequelae or deficits are possible. They may range from severe (patient remaining in coma), to paralysis of hands and/or legs, speech impairment, swallowing issues and memory or cognitive issues. Loss of major sensory functions such as vision or hearing may also occur.
There are some patients, who recover completely. However, some of them suffer long term problems. The severity of problems can be reduced by proper management including rehabilitation (physiotherapy, occupational therapy, speech therapy, cognitive therapy, etc.) along with Regenerative Medicine. These can help improve quality of life and take the patient a step towards functional independence.
A) In a comatose patient: complications that any bed-ridden patient will have are possible, such as bedsores, deep vein thrombosis, chest infections, etc.
B) Deformities/contractures, due to disuse of limbs are possible, if rehabilitation is not done regularly
C) Myositis ossificans: Calcium and bone deposits in the joints are a common problem in TBI, which restricts joint movements and ambulation. Deep massages, hence, should be avoided.
D) Fits/seizures: Some patients, who have suffered a TBI also have potential of seizures. Hence, are generally started on antiepileptic.
Regenerative Medicine along with rehabilitation helps in recovery of neurological deficits. It also helps in improving other problems, which are not improved by rehabilitation alone.
Our experience suggests that, aggression reduces, memory improves, and Speech improves along with other motor/physical functions.
The biological task of cell is to repair and regenerate damaged cells. Regenerative Medicine exploits this function by administering these cells in high concentrations directly in and around the damaged tissue, where they promote self-healing and repair.
Bone marrow transplantation has been used successfully for genetic disorders of blood, such as sickle cell anaemia, thalassemia, as well as cancers such as leukaemia. Since our therapy uses these very cell, which are harvested from the patient's own body (autologous cells), there are no major ethical concerns. Ethical concerns are primarily on the use of embryonic cell (which we do not use).
Regenerative Medicine is minimally invasive and reasonably safe. None of our patients have shown any neurological deterioration so far in connection with Regenerative Medicine itself. Some side effects, such as headache (spinal headache) lasting 3-4 days which is generally self-limiting, neck/back pain, vomiting, some mild rash or pain at the site of bone marrow aspiration/cell injection may occur. However, like any other medical or surgical treatment unexpected complications are always a possibility. These complications may be related to the medicines given, the cell procedure, the anaesthesia, and the rehabilitation or to any of the pre-existing medical or neurological conditions.
Maximal improvements are seen around 3-6 months after the treatment. However, in many patients there are slow progressive improvements that continue for several months/years later. Most patients do show some immediate improvements also i.e. before the discharge, in some of their symptoms.
The decision to do the therapy a second time is taken after seeing the progress/improvements after the first therapy. If the patients show some encouraging improvement, then the case is reviewed by the entire medical and rehabilitation team and a second treatment may be recommended. This may be done anytime between 3-6 months of the first therapy.
We will review what other medications the patient is already on. In most cases, we do not discontinue any already going on treatment. However, this is decided on a case by case basis. Blood thinners like aspirin, clopidrogel, warfarin, etc. needs to be stopped. Please inform us about any medications you are taking beforehand.
This is difficult to predict, since this a new therapy. It depends on multiple factors such as age of patient, type of illness, duration of illness and extent of rehabilitation taken after the treatment. It is important to note that at NeuroGen we give no assurances or guarantees of any definitive improvements or results. However our past clinical results demonstrate that 94.22% of patients showed overall improvement. Improvements were seen in higher mental functions, posture, trunk activity, upper limb activity, lower limb activity, coordination, oromotor function, ambulation, and Activities of Daily Living.
Our data is regularly analysed and published in various medical and scientific journals (available for reading on our website). You are strongly advised to study these before proceeding with treatment.
Case Reports
Miss ABC, a 7 year old female child and a case of Quadriparesis due to Traumatic Brain Injury met with a road accident in the year 2015 while crossing the street. She was immediately hospitalized as she was unconscious and for 3 months she was on ventilator as she couldn't breathe on her own. In the hospital slowly and gradually, she regained consciousness and could identify her parents.
Once discharged from the hospital, she was bedridden and completely dependent on her parents. They tried various treatment options like homeopathy and natural acupuncture but nothing worked. She was started on rehabilitation in terms of physiotherapy and occupational therapy post which there was mild improvement in her condition. She had 3 episodes of seizures post the accident and was started on anti-epileptics.
When she was hospitalized after the accident there was another patient with a brain disorder who told them about NeuroGen Brain & Spine Institute. They decided to approach NeuroGen to know more about Regenerative Medicine.
On examination following points were noted :
She could not speak or express herself but she used to respond with a smile when she was hungry.
She had an improper tone and posture
Sitting and standing balance was negligible.
She was completely dependent for bed mobility, transfers and ADLs
Both her right and left side movements were affected, but movements of left body parts were more affected than right side due to which she could not perform rolling, turning, kneeling.
She could not independently stand, sit or walk and had poor trunk control.
There was abnormal movement of toes of both legs
There was grade 2 tightness in calf muscles, thigh muscles and hip muscles - this tightness restricted movement of these body parts
She was on a PEG tube as she had problem in swallowing
At NeuroGen, she underwent Regenerative Medicine along with the Neuro rehabilitation program. The aim of the rehabilitation program was to develop trunk control, normalize tone, increase the strength of the affected areas without fatigue and increase overall stamina of the patient.
She was given exercises that would help her improve her balance, walking, stair climbing, cognition, poster, and his grip. These exercises carried out in a systematic pattern with sufficient rest intervals to the patient. Together, the aim of the rehabilitation program was to improve her overall quality of life.
Physiotherapy and rehabilitation taught at NeuroGen were continued after going home. Parents found new hope with NeuroGen's Regenerative Medicine. They were motivated and positive for their child after going back.
After 4 months of Regenerative Medicine at NeuroGen following improvements were seen:
She had started swallowing her food, as compared to the PEG tube which was being solely used to feed her.
Her sitting stamina had increased and she could sit for 10 to 15 minutes with back support, earlier she was completely bedridden.
She was able to make sounds for communication
Cognition improved
She started communicating non-verbally by pointing at objects
Voluntary control of upper body improved
She started saying Amma and Papa
She was able to attempt standing with one person's support
Overall tightness of the body reduced
Her voluntary control of left hand improved, as compared to earlier.
