Study of Probable Benefit of the Neuro-Spinal Scaffold™ in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care

Who can take part

• AIS A classification of traumatic spinal cord injury at T2 - T12 neurological level of injury confirmed by a qualified medical professional
• Recent injury (must have open spine surgery within 7 days from injury)
• Injury Severity Score (ISS) ≤ 45 at the time of screening
• Glasgow Coma Scale, GCS ≥ 14 (GCS ≥ 10 for intubated subjects) at the time of the screening and GCS = 15 (GCS ≥ 10 for intubated subjects) within two hours prior to spine surgery
• Non-penetrating SCI (contusion injury) that is no less than approximately 4 mm in diameter by MRI
• Requires open spine surgery allowing access to the injured spinal cord (subjects requiring either posterior surgical approach or posterior plus anterior approach will be eligible)
• Informed consent obtained
• 16-70 years of age, inclusive
• Eight-hour period of hemodynamically stability (>90 mmHg systolic blood pressure) prior to open spine surgery

Who cannot take part

• Subjects with clinically significant pre-existing neurological comorbidities that are unrelated to the contusion being treated (e.g. MS, ALS, significant prior peripheral nerve dysfunction, residual problems related to previous spine-related neurological pathologies) will be excluded only if it is felt that these preexisting morbidities will increase risk, affect safety monitoring, or confound study results
• A female who is:; Pregnant, or planning to become pregnant within the next 12-months; or; Breastfeeding; or; A woman of child-bearing potential (defined as post menarche and biologically capable of becoming pregnant [i.e., not surgically sterile]) who is engaged in active heterosexual relations and is not willing to use a barrier or hormonal form of birth control for 12-months following open spine surgery (e.g., oral, injected, or implanted contraceptives)
• A male who is engaged in active heterosexual relations and is not willing to use birth control for 3-months following open spine surgery including sperm donation or banking
• Participation in another interventional clinical trial for six months after open spine surgery
• Having a medical condition (e.g., cardiovascular disease, life threatening injuries), or receiving medical treatment, or having any other reason that, in the judgment of the Investigator, precludes successful participation and follow-up for at least six months or confounds collection or interpretation of study safety, feasibility, or efficacy data
• Subjects receiving tetracyclines, such as minocycline (subjects must discontinue tetracyclines to be enrolled in the study; tetracyclines can be resumed after 6 months post-open spine surgery
• Subjects with clinically significant pre-existing respiratory disease not related to the contusion being treated (e.g., COPD)
• Subjects with documented immune deficiency disorders, including a known diagnosis of HIV infection/AIDS
• Recent (according to DSM IV or DSM V criteria) history of abuse of narcotics or other significant substance abuse
• Known hypersensitivity to PLGA or PLL (e.g., hypersensitivity to absorbable sutures containing PLGA)
• History of severe mental illness (according to DSM IV or V)
• Evidence of pre-trauma active local or systemic infection
• Terminally ill subjects not likely to be able to participate in follow-up
• Incomplete spinal cord injury (AIS B, C, D, and E injuries)
• Subjects with more than one discrete spinal cord injury
• No discrete cavity in the contused spinal cord in which a Scaffold can be placed
• Evidence of clear and significant Somatosensory Evoked Potentials (SSEP) transmission through the injury site (based on the judgment of the Investigator)
• Spinal cord injury associated with significant traumatic brain injury or coma that, in the opinion of the Investigator, would preclude adequate assessment of spinal cord function, brain injury that could be associated on its own with sensory or motor deficits, or subjects with any other reason that results in an unreliable ISNCSCI exam
• Subjects requiring long-term ongoing mechanical ventilation
• Significant injury complications where, in the view of the Investigator, participation in the study could further complicate subject care, limit study follow-up, or confound interpretation of safety or efficacy data
• Current or impending incarceration
• Complete spinal cord transection as determined by screening MRI
• Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds
• BMI over 39