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.

 

 

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What is Spinal
Cord Injury?

What is Spinal Cord Injury?

 

The Spinal Cord is the continuation and means of communication between the body and the brain. The nervous tracts extend from the brain and diverge through the spinal cord at various levels, from a network of nerve fibers all over the body, with the objective of sending sensory and motor information.

A spinal cord injury disrupts these signals, and usually occur as a result of a blow that fractures or dislocates your vertebrae, the bony disks that make up your spine. Some injuries don't cut through the spinal cord. Instead, they cause damage when pieces of vertebrae tear into cord tissue or press down upon the nerve parts that carry signals.

Spinal Cord Injury

Spinal cord injuries can be complete or incomplete. In a complete spinal cord injury, as a result of an absolute cord disruption, signals from the brain fail to reach below the level of the injury. As a result, the region supplied below that level, loses sensation and function.. With an incomplete injury, in which the cord is either partially cut, or compressed, there is some movement and sensation below the level of injury.

What causes a spinal cord injury?

The cause for spinal cord injury can be traumatic or non-traumatic.

  • Traumatic injury

    Direct hit or blow causing damage to the spinal cord, which could be for the following reasons:

    • Motor vehicle accidents

    • Falls from heights

    • Acts of violence

    • Sports and recreation injuries

    • Industrial accidents

    • Gunshot injuries

    Traumatic injury
  • Non-Traumatic injury

    Injury caused to the cord via infections, different diseases and lack of blood supply. Causes of non-traumatic injury are:

    • Transverse Myelitis

    • Cancer

    • Arthritis

    • Osteoporosis

    • Tuberculosis

What are the symptoms associated with spinal cord injury?

  • Sensations
    Below the neurological level of injury, one may lose part of or all skin sensations. Therefore, skin fails to send a message to the brain when it's injured by certain things such as prolonged pressure, heat or cold. This can make the person more susceptible to pressure sores, but by frequently changing positions, with help, if needed, can help prevent these sores and they can learn proper skin care during rehabilitation. Not only skin but damage to sensory nerves, also impairs ability to perceive joint positions and movements, pressure, vibration and other specialised sensations.

  • Muscle weakness
    Depending on the degree of injury(complete / incomplete), weakness of muscles occurs. In case of complete injury muscles have no strength below the level of injury, whereas, in an incomplete injury strength of some muscles may be preserved partially or completely.

  • Bladder control
    The bladder will continue to store urine from kidneys, however, the brain may not be able to control bladder because the transmitter(the spinal cord) has been injured. The lack of sensation & bladder control, thus, increase the risk of urinary tract infections. They also may cause kidney infections due to the backflow of urine, and kidney or bladder stones. During rehabilitation, patients are taught techniques to help empty their bladder.

  • Bowel control
    Although stomach and intestines work very much like they did before the injury, the control of bowel movements is often altered. A high-fiber diet may help regulate bowels, and techniques to optimize bowel function need to be learnt during rehabilitation.

    Sign of Spinal Cord Injury after an accident
  • Circulatory control
    A spinal cord injury may cause circulatory problems ranging from low blood pressure on rising(orthostatic hypotension), to swelling of extremities. The lack of movement and these circulation changes also may increase the risk of developing blood clots, such as deep vein thrombosis or pulmonary emboli. Another problem with circulatory control, is a potentially life-threatening rise in blood pressure(autonomic hyperreflexia).

  • Respiratory system
    In some people injury may make it more difficult to breathe and cough if the abdominal and chest muscles are affected. These include the diaphragm and the muscles in your chest wall and abdomen. The neurological level of injury will determine what kind of breathing problems one can get. Usually higher level of injury results in respiratory weakness. If it is cervical and thoracic spinal cord injury, there can be increased risk of pneumonia or other lung problems. Medications and therapy can treat these problems.

  • Muscle tone
    Some people with a spinal cord injury experience muscle tone problems; involuntary tightening or motion in the muscles(spasticity) or soft and limp muscles lacking muscle tone(flaccidity).

  • Fitness and wellness
    Weight loss and muscle atrophy are common, soon after a spinal cord injury, as a result of loss of nerve supply to the muscles and lack of movement. Limited mobility may lead to a more sedentary lifestyle, increasing the risk of cardiovascular disease and diabetes.

    A dietician plays a role in charting a nutritious diet to sustain an adequate weight.

    Physical and occupational therapists can help you develop a fitness and exercise program.

  • Sexual health
    Sexual function may be affected by spinal cord injury. Men may notice changes in erection and ejaculation; women may notice changes in lubrication. Doctors, urologists and fertility specialists who specialize in spinal cord injury can offer options for sexual functioning and fertility.

  • Pain
    Some people experience pain, such as muscle or joint pain, from overuse of particular muscle groups. Nerve pain, also known as neuropathic or central pain, can occur after a spinal cord injury, especially in someone with an incomplete injury.

  • Depression
    Coping with the sudden and unexpected changes which come along with spinal cord injuries, may cause severe depression.

What are the treatment options available for spinal cord injuries?

It is possible for some function to recover after the spinal cord injury. It is important that the primary aid or measures to minimize the injury should be taken immediately. This helps in preventing secondary injuries and reduce severity of the problem.

At the time of injury, the spinal cord swells. When the swelling goes down, either spontaneously, or due to medications or due to removal of compression, some functioning may return over a period of time. This is especially true in incomplete injuries, functioning may return as late as 18 months after the injury. There are major advances happening in the research field today, such as regenerative medicine, which can help improve signaling and functioning in a SCI patient.

Signaling and Functioning in a SCI patient

Unfortunately, there are at present no known ways to reverse damage to the spinal cord. However, researchers are continually working on new treatments, including prostheses and medications, which may promote regeneration of nerve cells or improve the function of the nerves that remain after a spinal cord injury.

Spinal cord injury treatment currently focuses on preventing further injury and empowering people with a spinal cord injury to return to an active and productive life. Regular rehabilitation and with the help of assistive devices quality of life can be improved.

Regular rehabilitation of SCI patient

Multidisciplinary rehabilitation forms the mainstay of the treatment for spinal cord injury patients. Extensive rehabilitation has shown improvements in muscle strength, balance, bowel and bladder, sensory recovery and functional recovery.

Medical and surgical management is symptomatic for spasticity, bladder and bowel, pressure sores, gastrointestinal problems and abnormal sensations arising from regions below the level of injury.

How does Regenerative Medicine help in Spinal Cord Injury?

Regenerative Medicine has a great potential as a treatment for spinal cord injury (SCI). Extensive research has been conducted in animal models and humans with spinal cord injury, to study the efficacy of this intervention. It essentially focuses on replacing the lost or damaged cells and promoting axonal growth and remyelination of axons. The cells migrate to the site of injury and initiate a repair process. They release trophic factors to stop neuronal degeneration and stimulate angiogenesis. These factors also activate the dormant cells and recruit them to the injured site.

Experimental models have demonstrated the formation of functional neuronal circuits promoting functional recovery. They also modulate the immune response after injury, induce breakdown of inhibitory scars within the spinal cord and eliminate cell debris and protect neurons.

The NeuroGen Outcome

In NeuroGen we have treated more than 650 spinal cord injury patients with autologous bone marrow derived regenerative medicine and have found improvements in almost all the affected areas caused due to the injury.

Spinal Cord Injury patients with autologous bone marrow
  • A detailed analysis of chronic thoracolumbar spinal cord injury patients who underwent intrathecal administration of autologous bone marrow mononuclear cells followed by neurorehabilitation was conducted. The study sample included 110 thoracolumbar spinal cord injury patients. The outcome was recorded at a mean follow up of 2 years ±1 month. 100 out of 110 (91%) patients showed improvements. Improvement in trunk control was observed in 95.6% cases, bladder management in 33% with respect to shift from indwelling and condom catheter to self-intermittent catheterization, partial sensory recovery in 27% and reduction of spasticity in 26%. All the patients showed improvement in postural hypotension. 38% wheelchair bound patients started walking with assistance. Functionally, 27% showed improved activities of daily living (ADLs) and 53.6% showed a positive change in functional independence measure (FIM) score. 10% cases showed a shift in ASIA scale.

    A detailed analysis of chronic thoracolumbar spinal cord injury patients
  • A detailed analysis of chronic cervical spinal cord injury patients who underwent intrathecal administration of autologous bone marrow mononuclear cells followed by neurorehabilitation was conducted. This study includes 50 patients of chronic cervical spinal cord injury. The outcome was recorded at a mean follow up of 2 years ±1 month. 37 out of 50 (74%) showed improvements. Sensation recovery was observed in 26% cases, improved trunk control in 22.4%, spasticity reduction in 20% and bladder sensation recovery in 14.2%. All the 50 cases had improvement in postural hypotension. 12.24% wheelchair bound patients started walking with assistance. Functionally, 20.4% patients showed improved activities of daily living and 48% showed a positive change in FIM score. 6% cases showed a shift in American spinal cord injury assessment (ASIA) scale.

Graph demonstrating symptomatic improvements in Spinal Cord Injury patients after regenerative medicine

Graph demonstrating symptomatic improvements in Spinal Cord Injury patients after cell therapy

Frequently asked questions

Q1) What is the difference between paraplegia & quadriplegia?

Paraplegia is a condition where there is a loss in control of movement and sensation from the waist down, i.e. mainly in the legs. The term quadriplegia includes loss of function in the upper body as well as lower body i.e. inability to arms, hands and legs.

Q2) What is the difference between a 'complete' and 'incomplete' injury?

'Complete' injury implies that there is effectively no transmission of signals across a spinal cord lesion, with no voluntary control of movement or perception of sensations below the lesion. 'Incomplete' injuries are those where some of the pathways across the spinal cord lesion are undamaged. The outcome can be extremely variable and depends on which parts of the spinal cord are damaged.

Q3) Do people with SCI ever get better?

It is possible for some function to recover after the spinal cord injury. It is important that the primary aid or measures to minimize the injury should be taken immediately. This helps in preventing secondary injuries and reduce severity of the problem.

At the time of injury, the spinal cord swells. When the swelling goes down, either spontaneously, or due to medications or due to removal of compression, some functioning may return over a period of time.This is especially true in incomplete injuries, functioning may return as late as 18 months after the injury. There are major advances happening in the research field today, such as regenerative medicine, which can help improve signaling and functioning in a SCI patient.

Q4) Is there a cure for SCI?

Most body parts and organs can repair themselves after they are injured. However the central nervous system doesn't completely recover. It is difficult to repair damage caused to the brain and spinal cord. Nevertheless, the damage caused by an SCI can be reduced by limiting immediate cell death and reducing the inflammation of the injured cord. Attempts to regenerate function in the damaged area are focusing on regrowing nerves, blocking the mechanism that stops neurons from re-growing themselves, inserting new cells and bypassing the damaged area.

Q5) What is life expectancy after SCI?

Life expectancy is not reduced because of spinal cord injury, per se. Complications due to the injury and if proper after care is withheld, leads to mortality. Complications, such as chronic kidney failure, chest infections, deep vein thrombosis, may lead to premature death. These can be avoided by taking proper care, preventing urinary tract infections, bed sores, chest physiotherapy and other physical therapy.

Q6) What must a patient of SCI, or their caretaker need to ensure after the injury? What are the "MUST KNOWS"?

In our experience, the immediate treatment focus has to be in stabilising the vertebra and releasing any compression caused upon the spinal cord, surgically. Once that is achieved, caretakers and patients need to be also counseled about, what to expect after injury.

-Must know 1
The injury evolves over a period of 6 months. First, the hands and legs would be loose or flaccid. Over a period of time, they will become stiff and spastic. This is expected and the natural evolution of the condition.

-Must know 2
Rehabilitation or physiotherapy, should be started as soon as advised by the surgeon. Passive movement of the limbs is essential to prevent blood clotting in the legs(deep vein thrombosis).

-Must know 3
Patient needs to be turned every 2 hours, to prevent bedsores. Additional, special type of beds can be used(but they are not substitutes for turning).

-Must know 4
For prevention of urinary tract infection, regularly consult a urologist, drink lots of fluid and take care of catheter hygiene. In paraplegics, since hands are functioning, take advice regarding self intermittent catheterization.

Q7) How is sexuality is affected by spinal cord injury and is it possible to conceive a child?

Sexual function is generally affected in patients with spinal cord injury, to varying extents, especially in males. However, it is possible to rehabilitate the patient, with the help of an andrologist. In our experience, we have seen that males with sexual dysfunction have been able to have intercourse, in a modified way, with help of medicines.

Child bearing is possible in a female with spinal cord injury. In a male with SCI, spontaneous conception has been seen in few spouses. Assisted reproduction is a possibility, which should be considered, otherwise.

Q8) What is the role of rehabilitation and how can NeuroGen help us?

Neurorehabilitation has a major role in patients with spinal cord injury. It helps in getting the patient on the way to leading an independent life.

At NeuroGen, we have various rehabilitation experts. Physiotherapy, occupational therapy, aquatic therapy, psychological counseling, along with expert advice on urological issues, bedsores, sexual rehabilitation, all is available under one roof.

Along with that, new age treatment options, such as regenerative medicine, are also provided under the expert guidance of a neurosurgeon.

Q9) What is the role of regenerative medicine in spinal cord injury?

Cells hold potential for treating spinal cord injuries. Transplantation studies in animals have shown that a transplantation of cell or stem-cell-derived cells may contribute to spinal cord repair by:

  • replacing the nerve cells that have died as a result of the injury.

  • generating new supporting cells that will re-form the insulating nerve sheath(myelin) and act as a bridge across the injury to stimulate regrowth of damaged axons.

  • protecting the cells at the injury site from further damage by releasing protective substances such as growth factors, and soaking up toxins such as free radicals, when introduced into the spinal cord shortly after injury.

  • preventing the spread of the injury by suppressing the damaging inflammation that can occur after injury.

Q10) How does regenerative medicine work?

The biological task of cell is to repair and regenerate damaged cells. regenerative medicine utilises this function by administering these cells in high concentrations directly in and around the damaged tissue, where they advance its self healing and repair.

Q11) Are there ethical concerns surrounding adult cell research and therapy?

Bone marrow transplantation has been used successfully for genetic disorders of blood, such as sickle cell anemia, thalassemia, as well as cancers such as leukemia. Since our therapy uses these very cells, 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).

Q12) Is the treatment painful?

The therapy is done under local anesthesia and a mild sedation. There is no significant pain or discomfort during or after the procedure.

Q13) Does the treatment have any side effects?

Regenerative Medicine is minimally invasive and reasonably safe. None of our patients have shown any neurological deterioration so far in connection with the regenerative medicine itself. Some short-term 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 anesthesia, and the rehabilitation or to any of the pre-existing medical or neurological conditions.

Q14) How long will it take me to know that I have benefitted from the treatment?

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.

Q15) Is the transplantation of the cell done once or more than once?

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.

Q16) Can other treatments be taken at the same time?

We will review what other medications and treatments the patient is already on. In most cases we do not discontinue any ongoing treatments. However, this is decided on a case by case basis. Blood thinners like aspirin, clopidogrel, warfarin, etc. need to be stopped. Please inform us about any medications you are taking beforehand.

Q17) How much improvement will the patient have?

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.

We have treated over 650 spinal cord injury (SCI) patients at NeuroGen BSI with regenerative medicine. We have published 2 studies of our clinical results in SCI one of thoracolumbar injury and another of cervical injury

The first study published in "The Journal of Neurorestoratology" included 110 patients with chronic thoracolumbar injury and paraplegia and reported that 91% of the patients had shown clinical improvements. The second study published in "The Journal of Neurological disorders" included 50 patients of chronic cervical SCI and quadriplegia and reported that 74% of the patients showed clinical improvements.

Improvements were recorded in various symptoms like sensation, spasticity, muscle tone, bladder/bowel function, trunk control, ambulation and activities of daily living.

Our data is regularly 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

Case report 1

A young 23 year old American-Indian girl, Miss VM, who was declared clinically dead thrice in US, was able to achieve a new life, with the help of regenerative medicine carried out at NeuroGen Brain and Spine Institute. She lost her entire sensation and mobility which started with one simple cold, cough and high fever. The sufferings of her health started after she returned to US from a family trip in India in 2006.

Her parents took her to the hospital where the doctors, after doing check-up and some tests, said it was just a normal fever due to shift in weather conditions or travel exertion, and so prescribed general course of medications. For many days she followed the medication course but there was no improvement, in fact her condition kept deteriorating. She was then admitted in an emergency ward and doctors decided to do Lumbar Puncture. Several tests like blood work-ups, MRI, CT scan, X-ray, Urine etc., were done. All reports were normal and during the four years time frame, she went into a coma, and was declared clinically dead thrice and not just that; the doctors had planned to disconnect the ventilators as well.

After fighting against death 3 times she finally returned to the US in November. The famous line 'A mother can do anything for her baby ' proved to be true. Her mother realized no one is giving rehabilitation to VM wholeheartedly and so she started giving rehab at home throughout the day with straws and cookies. She gained some sensation and a little hand movement but at a very slow pace.

The family decided to move down to India in August 2008 for an Ayurveda treatment. There was no improvement. In October 2008 they moved to Mumbai. Here they tried all types of treatments and rehabilitations.

One of our treated patients referred VM to visit NeuroGen Brain and Spine Institute for Regenerative Medicine. She was finally diagnosed as a known case of Transverse Myelitis at NeuroGen. Transverse Myelitis is a neurological disorder caused by inflammation(swelling) across both sides of one level, or segment, of the spinal cord.

At NeuroGen Brain and Spine Institute, she underwent regenerative medicine in 2010 combined with an extensive rehabilitation program consisting of physiotherapy, occupational therapy, diet counseling, urological counseling and psychological counseling. After regenerative medicine she gained back her superficial sensations, some mobility and strength in few muscles. Her upper body muscle strength improved tremendously, slowly she regained trunk control and sitting and standing balance.

Before coming to NeuroGen her spine was curved due to muscle weakness which is known as scoliosis, she had no mobility, no sensation at all below her neck. She was completely dependent for all day-to-day activities like turning around in bed, moving from one place to another. She couldn't move her body by herself. Her sitting posture was tilted and required support. 2-3 people were required to be with her round the clock.

After experiencing sustained improvements, she underwent regenerative medicine for the second time in 2013. This time she started walking with callipers and support, gained more strength, became totally independent in terms of everyday living activities and could travel alone on wheelchair.

This boosted her self-confidence and so she took first step towards making a bright career. She was a content writer at a leading social awareness blog. Along with this the queen of drama went for many photo shoots for various awareness campaigns.

The full of life wheelchair bound young girl was crowned Miss Wheelchair India - 1st runner up for the year 2014.

The desire to become fully mobile, to dance, to travel etc made her to undergo the regenerative medicine for the 3rd time in 2014. The rehabilitation given to VM at NeuroGen helped her to gain momentum in her life. She still comes to NeuroGen Brain & Spine Institute for rehabilitation and claims it to be the best rehabilitation centre in Mumbai.

Regenerative medicine changed her life. NeuroGen has given her a new independent life. Now she can sit with erect posture, her upper body has become totally fit and normal. She has gained strength in her trunk muscles and few muscles of her leg after 1st cell transplantation and she started travelling alone on a wheel chair, this means she could move herself from chair to the cab and vice versa with minimal assistance. She has now started climbing chairs and can walk with the help of walker and knee splints.

Clinical Improvements seen in Miss VM after regenerative medicine:-

  • Her speed while walking has increased.

  • Her posture has improved and lateral lurch has reduced.

  • She can do reach outs in sideways while sitting.

  • She can stand in parallel bars independently for few seconds without holding the railing support.

  • Her bed mobility has improved.

  • She has regained all superficial (touch, pain, temperature) sensations.

  • Spasticity in the lower limbs has reduced.

  • She can climb stairs with calipers

  • Her trunk strength has improved.

The three times clinically dead declared girl is not just surviving but also standing on her own feet, thanks to the regenerative medicine and rehabilitation. She is now settled in India with her parents as she is still undergoing treatment.

 

Case Report 2:

A passionate sports bike rider, Mr.HA was working as a Second officer in merchant navy. In 2013 when he was riding back home, his bike slipped and banged a bus stand pole. He was riding at 80-100 kmph and reached 0 kmph within fraction of seconds. Claims to it as a 'Dark Night' his bike crashed, helmet was in pieces and broke his spine. The spinal cord was injured at D5-D6 Level and due to mishandling of his spine by the helping hands, and lack of Emergency Medical Service(EMS) bone fragments entered in the cord, spinal compression happened along with breakage of ribs and internal bleeding. He was operated after 3 days because of non-availability of doctors and operation theatres which ultimately led the injury to further worsen. He was declared as paraplegic with no movement, no sensation in his lower body. He could not feel his limbs, could not stand/sit, no bladder or bowel control and felt that his lower body is non-existent. When the doctors or therapists tried to make him stand he used to faint within 5 seconds. He was out for various treatments like acupressure, acupuncture, homeopathy, massage, medications and extensive physiotherapy for more than a year but could achieve only some tingling sensations.

His hope of coming back to his feet made him search for treatment options all over the internet. After researching for almost 8 months about regenerative medicine, HA read an article about a patient treated at NeuroGen Brain and Spine Institute in one of the leading newspapers which made him reach NeuroGen with hope.

HA underwent regenerative medicine in 2014 and since then he is on his way up on the improvement ladder. Now the speed lover has gained speed in his fight against dependency.

Clinical Improvements seen in HA after Regenerative Medicine:-

  • He can stand without splints, independently and also can take few steps

  • While standing he can stand with one hand support in parallel bar.

  • Sitting static and dynamic balance has improved.

  • Trunk mobility is better.

  • Transfer from one place to another is easier.

  • There is vague contraction of abdomen, right quadriceps and quadratus lumborum muscles.

  • Deep pressure can be felt till right thigh and overall abdomen

  • He can feel when he is passing urine and can feel the sensation 15 second before.

  • Overall endurance has improved.

He has passion for cooking, which made him learn cooking and baking from Internet/Youtube. HA's confectionery businesses expanding rapidly.

He is now a fully motivated businessman with an aim of expanding his business to a larger scale, also he wants to motivate as many people as possible with spinal cord injury to not give up HOPE. Every day he is working towards gaining complete independence.