Clinical trial NCT03762655: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Injury, Spinal Cord
Lead sponsor: InVivo Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in AIS grade of one or more levels
timeFrame: 6 months post-implant
Secondary outcomes:
measure: Change in Neurological Level of Injury (NLI)
timeFrame: 3-months, 6-months, 12-months, 24-months post-open spine surgery
measure: Change in motor scores
timeFrame: 3-months, 6-months, 12-months, 24-months post-open spine surgery
measure: Change in sensory scores
timeFrame: 3-months, 6-months, 12-months, 24-months post-open spine surgery
measure: Changes in bladder, bowel, and sexual function
timeFrame: 6-months, 12-months and 24-months, post-open spine surgery
measure: Changes in spinal cord dimension
timeFrame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
measure: Changes in spinal cord lesion size
timeFrame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
measure: Changes in spinal cord lesion location
timeFrame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
measure: Changes in spinal cord anatomy-Presence of cyst
timeFrame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
measure: Changes in cyst size, if present
timeFrame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
measure: Changes in cyst location, if present
timeFrame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Colorado Springs
country: United States
facility: University of Colorado Memorial Hospital Central
state: Colorado
city: Tampa
country: United States
facility: University of South Florida Health Neurosurgery
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Newark
country: United States
facility: Rutgers Center for Spine Surgery
state: New Jersey
city: Elmhurst
country: United States
facility: Elmhurst Hospital Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center-Presbyterian
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: San Antonio
country: United States
facility: University of Texas Health San Antonio
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: