SCI/TBI Learn

SCI/TBI Learn

TBI –  Brain Injury has been identified as a second application of the company’s technology. There are two types of acquired brain injury: traumatic and non-traumatic:

  • Traumatic brain injury (TBI) is defined as an alteration in brain function, or other evidence of brain pathology, caused by an external Examples of TBI include falls, assaults, motor vehicle accidents and sports injuries.
  • Non-Traumatic Brain Injury (NTBI) – often referred to as an acquired brain injury. It causes damage to the brain by internal factors, such as a lack of oxygen, exposure to toxins, pressure from a tumor and so on. Examples of NTBI include stroke, near-drowning, aneurysm, tumor, infectious diseases that affect the brain (such as meningitis) or lack of oxygen supply to the brain (such as heart attack).

TRAUMATIC BRAIN INJURY

TBI is one of the major causes of death and disability worldwide. An estimated 1.7 million people sustain TBI each year in the United States, and more than 5 million people are coping with disabilities from TBI at an annual cost of more than $76 billion 17.

As far as the company is aware, despite improved supportive and rehabilitative care of TBI patients, no effective pharmacological treatments are available for reducing TBI mortality and improving functional recovery because all phase II/III TBI clinical trials have failed.

Emerging preclinical data indicate that restorative therapies targeting multiple parenchymal cells including cerebral endothelial cells, neural stem/progenitor cells and oligodendrocyte progenitor cells enhance TBI-induced angiogenesis, neurogenesis, axonal sprouting, and oligodendrogenesis,

respectively (Xiong et al., 2009). These interacting neuroplastic events in concert improve neurological function after TBI.

There is a compelling need to develop novel therapeutics specifically designed to stimulate neuroplasticity which subsequently promote neurological recovery after TBI.

SPINAL CORD INJURIES

The spinal cord is situated within the spinal column. It extends down from the brain to the L1−L2 vertebral level, ending in the conus medullaris. Continuing from the end of the spinal cord, in the spinal canal, is the cauda equina (or “horse’s tail”). The spinal cord itself has neurological segmental levels that correspond to the nerve roots that exit the spinal column between each of the vertebrae.

There are 31 pairs of spinal nerve roots: 8 cervical, 12 thoracic, 5 lumbar, 5 sacral and 1 coccygeal. Owing to the difference in length between the spinal column and the spinal cord, the neurological levels do not necessarily correspond to the vertebral segments.

Damage to the spinal cord may be:

  1. Traumatic SCI can result from many different causes – including falls, road traffic injuries, occupational and sports injuries, and violence.
  2. Non-traumatic SCI, usually involves an underlying pathology – such as infectious disease, tumor, musculoskeletal disease such as osteoarthritis, and congenital problems.

Symptoms of spinal cord lesion depend on the extent of the injury or non-traumatic cause, but they can include loss of sensory or motor control of the lower limbs, trunk and the upper limbs, as well as loss
of autonomic (involuntary) regulation of the body. This can affect breathing, heart rate, blood pressure, temperature control, bowel and bladder control, and sexual function.
In general, the higher up the spinal cord the lesion occurs the more extensive the range of impairments will be.
Cervical SCI commonly causes sensory and motor loss (paralysis) in the arms, body and legs, a condition called tetraplegia (the alternative term quadriplegia is now less used). Someone with C4 or higher lesions may require a ventilator to breathe because the lesion directly interferes with autonomic control. Thoracic SCI commonly causes sensory and/or motor loss in the trunk and legs, a condition called paraplegia. Lumbar SCI typically causes sensory and motor loss in the hips and legs.
All forms of SCI may also result in chronic pain. The extent and severity of sensory, motor and autonomic loss from SCI depends not only on the level of injury to the spinal cord, but also on whether the lesion is “complete” or “incomplete.”
According to the International Standards for Neurological Classification of SCI, with the American Spinal Injury Association (ASIA) Impairment Scale (AIS), an SCI is considered complete if there is no sensory and motor function at S4−S5. While some sensory and or motor function is preserved below the level of injury in incomplete SCI, including the lowest sacral segments S4-S5, it is no less serious and can still result in severe impairments

Injury

Symptoms of spinal cord lesion depend on the extent of the injury or non-traumatic cause, but they can include loss of sensory or motor control of the lower limbs, trunk and the upper limbs, as well as loss

of autonomic (involuntary) regulation of the body. This can affect breathing, heart rate, blood pressure, temperature control, bowel and bladder control, and sexual function.
In general, the higher up the spinal cord the lesion occurs the more extensive the range of impairments will be.
Cervical SCI commonly causes sensory and motor loss (paralysis) in the arms, body and legs, a condition called tetraplegia (the alternative term quadriplegia is now less used). Someone with C4 or higher lesions may require a ventilator to breathe because the lesion directly interferes with autonomic control. Thoracic SCI commonly causes sensory and/or motor loss in the trunk and legs, a condition called paraplegia. Lumbar SCI typically causes sensory and motor loss in the hips and legs.
All forms of SCI may also result in chronic pain. The extent and severity of sensory, motor and autonomic loss from SCI depends not only on the level of injury to the spinal cord, but also on whether the lesion is “complete” or “incomplete.”
According to the International Standards for Neurological Classification of SCI, with the American Spinal Injury Association (ASIA) Impairment Scale (AIS), an SCI is considered complete if there is no sensory and motor function at S4−S5. While some sensory and or motor function is preserved below the level of injury in incomplete SCI, including the lowest sacral segments S4-S5, it is no less serious and can still result in severe impairments

PREVALENCE

According to the World Health Organization, the estimated global SCI incidence is 40 to 80 new cases per million population per year, based on quality country-level incidence studies of SCI from all causes. This means that every year, between 250,000 and 500,000 people become spinal cord injured worldwide.

Given the current U.S. population size of 328 million people, a recent estimate showed that the annual incidence of SCI (SCI) is approximately 54 cases per one million people in the United States, or about 17,730 new SCI cases each year. New SCI cases do not include those who die at the location of the incident that caused the SCI.

The estimated number of people with SCI living in the United States is approximately 291,000, with a range from 249,000 to 363,000 persons. It is estimated that in Europe there are up to 500,000 people living with SCI with at least 27,000 new SCI cases each year.

The average age at injury has increased from 29 to 43 since the 1970s. About 78% of new SCI are male.

Vehicle crashes are the most recent leading cause of injury, closely followed by falls. Acts of violence (primarily gunshot wounds) and sports/recreation activities are also relatively common causes:

Lengths of stay in the hospital acute care unit have declined from 24 days in the 1970s to 11 days recently. Rehabilitation lengths of stay have also declined from 98 days in the 1970s to 31 days recently.

Recently, incomplete tetraplegia is the most frequent neurological category. The frequency of incomplete and complete paraplegia is virtually the same. Less than 1% of persons experienced complete neurological recovery by the time of hospital discharge:

SINCE 2015

Since 2015, about 30% of persons with SCI are re-hospitalized one or more times during any given year following injury. Among those re-hospitalized, the length of hospital stay averages about 19 days. Diseases of the genitourinary system are the leading cause of re-hospitalization, followed by disease of the skin.

Respiratory, digestive, circulatory, and musculoskeletal diseases are also common causes.

The average annual expenses (health care costs and living expenses) and the estimated lifetime costs that are directly attributable to SCI vary greatly based on education, neurological impairment, and pre-injury employment history.

The estimates below do not include any indirect costs such as losses in wages, fringe benefits, and productivity (indirect costs averaged $76,327 per year in 2018 dollars).

SCI-Market-Table

Data Source: Economic Impact of SCI published in the journal Topics in Spinal Cord Injury Rehabilitation, Volume 16, Number 4, in 2011. ASIA Impairment Scale (AIS) is used to grade the severity of a person’s neurological impairment following spinal cord injury

The average remaining years of life for persons with SCI have not improved since the 1980s and remain significantly below life expectancies of persons without SCI. Mortality rates are significantly higher during the first year after injury than during subsequent years, particularly for persons with the most severe neurological impairments:

The average remaining years of life for persons with SCI have not improved since the 1980s and remain significantly below life expectancies of persons without SCI. Mortality rates are significantly higher during the first year after injury than during subsequent years, particularly for persons with the most severe neurological impairments: