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

Randomized, Controlled, Single-blind Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care

This is a randomized, controlled, single-blind, multicenter, two Arm (Treatment or "Scaffold" Arm; Standard of Care or "Comparator" Arm) of a Neuro-Spinal Scaffold to evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12 spinal cord injury as compared to standard of care open spine surgery.

This is a randomized, controlled, single blind, two-arm, multicenter Humanitarian Device Exemption (HDE) study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold ("Scaffold") in subjects with thoracic AIS A traumatic spinal cord injury at neurological level of injury of T2-T12 as compared to standard of care open spine surgery. Subjects will be randomized in a blinded manner to one of two study arms, the Treatment or "Scaffold" Arm and the Standard of Care or "Comparator" Arm. Subjects in the Scaffold Arm will have the Scaffold implantation immediately following standard of care open spine surgery. Subjects in the Comparator Arm will have standard of care open spine surgery and will not receive the Scaffold. The subjects will be blinded to their study arm for the duration of the study.

Primary Objective: To evaluate whether the Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12 spinal cord injury as compared to standard of care open spine surgery.

Regulatory Objective: To enhance the clinical evidence for the Scaffold in the treatment of complete thoracic spinal cord injuries.

Intended Use: The Scaffold is intended for use in patients age 16-70 years diagnosed with a T2-T12 neurological level of injury functionally complete (AIS A) spinal cord injury for whom open spine surgery, (e.g., laminectomy, spine stabilization) which allows access to the dura of the injured spinal cord, is recommended as an option. The Scaffold is intended to be implanted in a cavity at the epicenter of the spinal cord contusion during open spine surgery. The Scaffold is intended for use in recent (≤7 days) spinal cord injuries that do not involve penetrating injury to the cord or complete severing of the cord.

Inclusion Criteria:

1. AIS A classification of traumatic spinal cord injury at T2 - T12 neurological level of injury confirmed by a qualified medical professional
2. Recent injury (must have open spine surgery within 7 days from injury)
3. Injury Severity Score (ISS) ≤ 45 at the time of screening
4. 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
5. Non-penetrating SCI (contusion injury) that is no less than approximately 4 mm in diameter by MRI
6. 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)
7. Informed consent obtained
8. 16-70 years of age, inclusive
9. Eight-hour period of hemodynamically stability (>90 mmHg systolic blood pressure) prior to open spine surgery

Exclusion Criteria:

1. Terminally ill subjects not likely to be able to participate in follow-up

2. Incomplete spinal cord injury (AIS B, C, D, and E injuries)

3. Subjects with more than one discrete spinal cord injury

4. No discrete cavity in the contused spinal cord in which a Scaffold can be placed

5. Evidence of clear and significant Somatosensory Evoked Potentials (SSEP) transmission through the injury site (based on the judgment of the Investigator)

6. 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

7. 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

8. Subjects with clinically significant pre-existing respiratory disease not related to the contusion being treated (e.g., COPD)

9. Subjects requiring long-term ongoing mechanical ventilation

10. Subjects with documented immune deficiency disorders, including a known diagnosis of HIV infection/AIDS

11. Recent (according to DSM IV or DSM V criteria) history of abuse of narcotics or other significant substance abuse

12. 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.

13. 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)

14. 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

15. Current or impending incarceration

16. Complete spinal cord transection as determined by screening MRI

17. Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds.

18. Known hypersensitivity to PLGA or PLL (e.g., hypersensitivity to absorbable sutures containing PLGA)

19. History of severe mental illness (according to DSM IV or V)

20. Evidence of pre-trauma active local or systemic infection

21. Participation in another interventional clinical trial for six months after open spine surgery

22. BMI over 39

23. 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

24. 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