InVivo Therapeutics Holdings Corp (NVIV) has announced the recent Food & Drug Administration (FDA) approval for an increase in the number of patients involved in their pilot study for an investigational "Neuro-Spinal Scaffold" implant.
The number of thoracic SCI patients is being increased from five to ten, and the new technology will be implanted into patients diagnosed with acute thoracic spinal cord injuries. InVivo intends to use this single study as the basis for a Humanitarian Device Exemption (HDE) application.
Mark Perrin, CEO and Chairman of InVivo, publicly shared his excitement with this expansion, sharing that they are currently working on enrolling subjects to the ongoing pilot study.
Background on Thoracic Spinal Cord Injuries
Thoracic spinal cord injuries are those which occur to the thoracic vertebrae, which are found in the middle of the back. Thoracic injuries can result in paraplegia but are less common than other spinal cord injuries because of the rib cage’s protection the spine. These injuries are also known to cause loss of control and function of bowels, bladder, and sexual dysfunction.
There are 12 vertebrae which are referred to as thoracic, numbered as T1-T12. Injuries, and their effects on the body, are split into two categories; from T1-T5 and T6-T12. Regardless of where the injury occurs, the hands and arms are not usually impaired as they are controlled by higher levels of the spine.
Although many survivors will be able to stand and sit well, it isn’t uncommon for thoracic spinal cord injury patients to use wheelchairs and learn to drive modified cars.
How the Pilot Implant Works
The implant is surgically placed into the center of the wound, and acts as a physical substrate for nerve sprouting. Preclinical models of spinal cord contusion injuries have demonstrated decreased post-traumatic cyst formation and decreased spinal cord tissue pressure.
This investigational device has been awarded a Humanitarian Use Device (HUD) designation. A HUD is a device that is “intended to benefit patients by treating or diagnosing a disease or condition that affects, or is manifested in, fewer than 4000 individuals in the United States annually.”
The "Neuro-Spinal Scaffold" is also being studied in an Investigational Device Exemption (IDE) study for the treatment of patients with complete spinal cord injuries. An IDE allows investigational devices to be used in a clinical study in order to collect safety and effectiveness data. This device also received the 2015 Becker’s Healthcare Spine Device Award.
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