A Study of the Experimental Neuro-Spinal Scaffold™ Device for Complete Thoracic AIS A Spinal Cord Injury

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 16 to 70 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Spinal Cord Injury, Thoracic AIS A Spinal Cord Injury, Thoracic Spinal Cord Injury, back injury, spine injury, spine surgery
Type: Device study
Target:
3 Participants
Investigator:
Description
The purpose of this study is to test the safety and benefit of a new medical device. This device is implanted into the injured spinal cord for a recent spinal cord injury.

The procedure to implant the medical device may be added to the usual, standard treatment for spinal cord injury. The study doctor will attempt to perform your surgery as soon as possible. The medical device is experimental and is not approved by the FDA. There is no evidence that the medical device will be of any benefit to you. However, the study will look at whether the new medical device helps improve the medical condition of patients with recent spinal cord injuries.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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:
  14. Pregnant, or planning to become pregnant within the next 12-months; or
  15. Breastfeeding; or
  16. 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)
  17. 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
  18. Current or impending incarceration
  19. Complete spinal cord transection as determined by screening MRI
  20. Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds.
  21. Known hypersensitivity to PLGA or PLL (e.g., hypersensitivity to absorbable sutures containing PLGA)
  22. History of severe mental illness (according to DSM IV or V)
  23. Evidence of pre-trauma active local or systemic infection
  24. Participation in another interventional clinical trial for six months after open spine surgery
  25. BMI over 39
  26. 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
  27. 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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $150 per visit for your time and effort for completing visits 5,6,7,8. We will compensate you $50.00 per visit for completing visits 9-16. You will not be compensated for missed study visits. Reasonable travel costs for your travel reimbursement will be paid after written approval from the Sponsor.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 10 years. 2 years of visits to the study site and additional annual phone calls for years 3 - 10.
Recruitment period
From Dec. 13, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Janice Wang-Polagruto, PhD, CCRP
Research Topic
Conditions:
  • Injury
  • Spinal Cord