Status:
TERMINATED
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
Lead Sponsor:
InVivo Therapeutics
Conditions:
Injury, Spinal Cord
Eligibility:
All Genders
16-70 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03762655
Start Date
May 21 2019
End Date
December 31 2023
Last Update
January 17 2024
Active Locations (16)
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1
UC Davis Medical Center
Sacramento, California, United States, 95817
2
University of California San Diego
San Diego, California, United States, 92103
3
University of Colorado Memorial Hospital Central
Colorado Springs, Colorado, United States, 80909
4
University of South Florida Health Neurosurgery
Tampa, Florida, United States, 33613