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Cervical Spinal Cord Injury: Higher Risk/Higher Reward – March 23 2017

We at InVivo are very excited to have announced that Health Canada has approved the company’s Investigational Testing Authorization application to commence a clinical study in patients with acute, complete (AIS A) cervical spinal cord injuries in Canada. These patients are the most severely injured of all SCI patients and any neurological improvement could make a significant difference in their quality of life. As compared to the thoracic spinal cord, the cervical spinal cord represents a region of higher risk and higher potential reward, since each level of this region has substantial functional impact.

The most frequently used clinical instrument to assess spinal cord injuries is the International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. To understand the key differences between our newly-initiated cervical study and our ongoing thoracic INSPIRE study, it is helpful to understand how motor function is assessed in this exam. The most recent version of the exam can be found here: http://asia-spinalinjury.org/wp-content/uploads/2016/02/International_Stds_Diagram_Worksheet.pdf.

In the ongoing INSPIRE study, we are enrolling patients with neurologically complete (AIS A) paralysis at thoracic levels T2-T12/L1.  Perhaps surprisingly, the ISNCSCI exam doesn’t include evaluation of motor function for any of these thoracic levels. This is because the muscles innervated by the thoracic spinal cord, such as the abdominals, are clinically difficult to evaluate. The muscles of the lower limbs can be easily evaluated and are innervated by the lumbar and sacral spinal cord, which are below the thoracic region. For a patient with a T3 level injury, the closest region of the spinal cord that is evaluated for motor function in the ISNCSCI exam is at the L2 level, which is located about 7 inches away on the adult spinal cord. That is a lot of spinal cord between the level of injury and the closest region that can be measured for motor function!

In contrast, in the cervical study that we just announced, we will be evaluating the Neuro-Spinal Scaffold™ implant in patients with AIS A injuries at levels C5-T1. Every one of these levels has a measurable motor function that is included in the ISNCSCI exam. Specifically, the following muscles (with the corresponding innervating level) are bilaterally assessed in the ISNCSCI exam:

  • C5 – elbow flexors
  • C6 – wrist extensors
  • C7 – elbow extensors
  • C8 – finger flexors
  • T1 – small finger abductors

The C5-T1 region of the spinal cord is only about 2-2.5 inches long. If the Neuro-Spinal Scaffold were able to preserve, remyelinate, and/or regenerate just a small area of spinal cord, we believe this could have significant functional consequences.

As a specific example, if a patient with an AIS A injury at C7 were to experience two levels of neurological improvement to T1 (C7 and T1 are just over an inch apart), it could be the difference between having minimal-to-no hand function to having substantial-to-complete hand function. Improvements in this area have the potential to positively impact a person’s ability to interact with his or her environment. Daily activities such as feeding and bathing could be dramatically improved, which could lead to enhancements in overall quality of life.

Because of the importance of every inch and level of the cervical spinal cord, there is also increased risk of losing function in the event of any neurological worsening. However, the safety and ASIA Impairment Scale conversion data collected in the INSPIRE study are encouraging regarding the prospects of the Neuro-Spinal Scaffold in the cervical spinal cord. Our mission is to redefine the life of the SCI patient. With cervical spinal cord injuries accounting for a significant proportion of overall SCI, and representing the most severely-affected patients, we couldn’t be more enthusiastic about initiating this new study.

Mark Perrin
CEO & Chairman
March 23, 2017

Archives

How the 21st Century Cures Act Impacts InVivo - December 19, 2016
CEO's Perspective - October 19, 2016
Epidemiology and Market Opportunity Around the World - July 13, 2016
The INSPIRE Study - February 29, 2016
InVivo in 2016: Looking Ahead - December 17, 2015
Building Value in a Pre-commercialization Biotech Company: Importance of Increased Exposure Within the Scientific and Medical Communities - September 21, 2015
Corporate Financing - What are the options? - July 29, 2015
Social Media: The New Frontier - June 3, 2015
What NASDAQ has to Offer - April 16, 2015
Reverse Splits and Uplisting - March 24, 2015

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