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

Stopped early · Not applicable

Conditions studied: Injury, Spinal Cord

In brief

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.

Key facts

Study ID: NCT03762655
Run by: InVivo Therapeutics
People needed: 20
Starts: 2019-05-21
Expected to finish: 2023-12-31
Last updated by the study team: 2024-01-17

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)
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
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 with clinically significant pre-existing respiratory disease not related to the contusion being treated (e.g., COPD)
Subjects requiring long-term ongoing mechanical ventilation
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
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.
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
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.
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
Participation in another interventional clinical trial for six months after open spine surgery
BMI over 39

Where it is running

UC Davis Medical Center — Sacramento, California, United States
University of California San Diego — San Diego, California, United States
University of Colorado Memorial Hospital Central — Colorado Springs, Colorado, United States
University of South Florida Health Neurosurgery — Tampa, Florida, United States
University of Iowa — Iowa City, Iowa, United States
University of Maryland Medical Center — Baltimore, Maryland, United States
Rutgers Center for Spine Surgery — Newark, New Jersey, United States
Elmhurst Hospital Center — Elmhurst, New York, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Vidant Medical Center — Greenville, North Carolina, United States
Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
Thomas Jefferson University — Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center-Presbyterian — Pittsburgh, Pennsylvania, United States
Rhode Island Hospital — Providence, Rhode Island, United States
University of Texas Health San Antonio — San Antonio, Texas, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.