<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03762655</url>
  </required_header>
  <id_info>
    <org_study_id>InVivo-100-105</org_study_id>
    <nct_id>NCT03762655</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <acronym>INSPIRE 2</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InVivo Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InVivo Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, controlled, single-blind, multicenter, two Arm (Treatment or &quot;Scaffold&quot;&#xD;
      Arm; Standard of Care or &quot;Comparator&quot; Arm) of a Neuro-Spinal Scaffold to evaluate whether the&#xD;
      Scaffold is safe and demonstrates probable benefit for the treatment of complete T2-T12&#xD;
      spinal cord injury as compared to standard of care open spine surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, controlled, single blind, two-arm, multicenter Humanitarian Device&#xD;
      Exemption (HDE) study to evaluate the safety and probable benefit of the&#xD;
      poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold (&quot;Scaffold&quot;) in subjects with&#xD;
      thoracic AIS A traumatic spinal cord injury at neurological level of injury of T2-T12 as&#xD;
      compared to standard of care open spine surgery. Subjects will be randomized in a blinded&#xD;
      manner to one of two study arms, the Treatment or &quot;Scaffold&quot; Arm and the Standard of Care or&#xD;
      &quot;Comparator&quot; Arm. Subjects in the Scaffold Arm will have the Scaffold implantation&#xD;
      immediately following standard of care open spine surgery. Subjects in the Comparator Arm&#xD;
      will have standard of care open spine surgery and will not receive the Scaffold. The subjects&#xD;
      will be blinded to their study arm for the duration of the study.&#xD;
&#xD;
      Primary Objective: To evaluate whether the Scaffold is safe and demonstrates probable benefit&#xD;
      for the treatment of complete T2-T12 spinal cord injury as compared to standard of care open&#xD;
      spine surgery.&#xD;
&#xD;
      Regulatory Objective: To enhance the clinical evidence for the Scaffold in the treatment of&#xD;
      complete thoracic spinal cord injuries.&#xD;
&#xD;
      Intended Use: The Scaffold is intended for use in patients age 16-70 years diagnosed with a&#xD;
      T2-T12 neurological level of injury functionally complete (AIS A) spinal cord injury for whom&#xD;
      open spine surgery, (e.g., laminectomy, spine stabilization) which allows access to the dura&#xD;
      of the injured spinal cord, is recommended as an option. The Scaffold is intended to be&#xD;
      implanted in a cavity at the epicenter of the spinal cord contusion during open spine&#xD;
      surgery. The Scaffold is intended for use in recent (≤7 days) spinal cord injuries that do&#xD;
      not involve penetrating injury to the cord or complete severing of the cord.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 21, 2019</start_date>
  <completion_date type="Anticipated">July 2028</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects will be randomized in a blinded manner to one of two study arms, the Treatment or &quot;Scaffold&quot; Arm and the Standard of Care or &quot;Comparator&quot; 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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Subjects will be randomized in a blinded manner to one of two study arms, the Treatment or &quot;Scaffold&quot; Arm and the Standard of Care or &quot;Comparator&quot; 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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in AIS grade of one or more levels</measure>
    <time_frame>6 months post-implant</time_frame>
    <description>The proportion of subjects with an improvement of at least one AIS grade will be presented for each study arm.&#xD;
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations determine the ASIA Impairment Scale (AIS) grade.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Neurological Level of Injury (NLI)</measure>
    <time_frame>3-months, 6-months, 12-months, 24-months post-open spine surgery</time_frame>
    <description>The ISNCSCI examinations determine the the Neurological Level of Injury (NLI). The NLI refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided that there is normal (intact) sensory and motor function rostrally.&#xD;
NLI will be summarized for each study arm at visits (pre-surgery, 3-months, 6-months, 12-months, 24-months). Observed values and change from the baseline will be presented for each study arm.The ISNCSCI exam performed within 8 hours prior to surgery (pre-surgery ISNCSCI) will be used as the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in motor scores</measure>
    <time_frame>3-months, 6-months, 12-months, 24-months post-open spine surgery</time_frame>
    <description>A numerical summary score of motor function in each extremity determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination. This score can reflect the degree of neurological impairment associated with the SCI, with lower score indicating greater impairment. Score ranges from 0-25 for each extremity, with maximum scores of 50 for the upper limbs and 50 for the lower limbs.&#xD;
Motor scores will be summarized for each study arm at visits (pre-surgery, 3-months, 6-months, 12-months, 24-months). Observed values and change from the baseline will be presented for each study arm.The ISNCSCI exam performed within 8 hours prior to surgery (pre-surgery ISNCSCI) will be used as the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sensory scores</measure>
    <time_frame>3-months, 6-months, 12-months, 24-months post-open spine surgery</time_frame>
    <description>A numerical summary score of sensory function in each determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination. This score can reflect the degree of neurological impairment associated with the SCI, with lower score indicating greater impairment. Score ranges from 0-56 points each for light touch and pin prick (sharp/dull discrimination) modalities, with a maximum total score of 112 points per side of the body.&#xD;
Observed values and change from the baseline will be presented for each study arm.The ISNCSCI exam performed within 8 hours prior to surgery (pre-surgery ISNCSCI) will be used as the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in bladder, bowel, and sexual function</measure>
    <time_frame>6-months, 12-months and 24-months, post-open spine surgery</time_frame>
    <description>Bladder, bowel and sexual function will be assessed using the Lower Urinary Tract, Bowel and Sexual Function System/Organ section of the ASIA Autonomic Standards Assessment Form. The Autonomic Standards Assessment Form has three questions in each category (Lower Urinary Tract or bladder, Bowel, Sexual Function) and each question is scored on a scale from 0 (complete loss of control) - 2 (normal function). Observed values and change from baseline will be presented for each study arm. The hospital discharge visit will be used as the baseline visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in spinal cord dimension</measure>
    <time_frame>72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery</time_frame>
    <description>Spinal cord dimensions (above, at, and below level of injury) will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in spinal cord lesion size</measure>
    <time_frame>72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery</time_frame>
    <description>Lesion size (in mm) will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in spinal cord lesion location</measure>
    <time_frame>72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery</time_frame>
    <description>Lesion Location will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in spinal cord anatomy-Presence of cyst</measure>
    <time_frame>72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery</time_frame>
    <description>Cyst presence or absence will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cyst size, if present</measure>
    <time_frame>72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery</time_frame>
    <description>Cyst size, if present, will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cyst location, if present</measure>
    <time_frame>72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery</time_frame>
    <description>Cyst location, if present, will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Injury, Spinal Cord</condition>
  <arm_group>
    <arm_group_label>Neuro-Spinal Scaffold Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the Scaffold Arm will have the Scaffold implantation immediately following standard of care open spine surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in the Comparator Arm will have standard of care open spine surgery and will not receive the Scaffold.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neuro-Spinal Scaffold</intervention_name>
    <description>The investigational product (&quot;Neuro-Spinal ScaffoldTM&quot; or &quot;Scaffold&quot;) is a porous bioresorbable polymer scaffold comprised of a synthetic biomaterial, poly(lactic-co-glycolic acid)-b-poly(L-lysine) (PLGA-PLL). The Scaffold is cylindrical in shape (3 mm diameter) and is available is three lengths (6 mm, 8 mm, 10 mm) for optimal fit in the intraspinal lesion cavity.&#xD;
Based upon pre-clinical testing, the Scaffold is expected to be resorbed from the site of implant within 4 to 8 weeks.</description>
    <arm_group_label>Neuro-Spinal Scaffold Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. AIS A classification of traumatic spinal cord injury at T2 - T12 neurological level of&#xD;
             injury confirmed by a qualified medical professional&#xD;
&#xD;
          2. Recent injury (must have open spine surgery within 7 days from injury)&#xD;
&#xD;
          3. Injury Severity Score (ISS) ≤ 45 at the time of screening&#xD;
&#xD;
          4. Glasgow Coma Scale, GCS ≥ 14 (GCS ≥ 10 for intubated subjects) at the time of the&#xD;
             screening and GCS = 15 (GCS ≥ 10 for intubated subjects) within two hours prior to&#xD;
             spine surgery&#xD;
&#xD;
          5. Non-penetrating SCI (contusion injury) that is no less than approximately 4 mm in&#xD;
             diameter by MRI&#xD;
&#xD;
          6. Requires open spine surgery allowing access to the injured spinal cord (subjects&#xD;
             requiring either posterior surgical approach or posterior plus anterior approach will&#xD;
             be eligible)&#xD;
&#xD;
          7. Informed consent obtained&#xD;
&#xD;
          8. 16-70 years of age, inclusive&#xD;
&#xD;
          9. Eight-hour period of hemodynamically stability (&gt;90 mmHg systolic blood pressure)&#xD;
             prior to open spine surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Terminally ill subjects not likely to be able to participate in follow-up&#xD;
&#xD;
          2. Incomplete spinal cord injury (AIS B, C, D, and E injuries)&#xD;
&#xD;
          3. Subjects with more than one discrete spinal cord injury&#xD;
&#xD;
          4. No discrete cavity in the contused spinal cord in which a Scaffold can be placed&#xD;
&#xD;
          5. Evidence of clear and significant Somatosensory Evoked Potentials (SSEP) transmission&#xD;
             through the injury site (based on the judgment of the Investigator)&#xD;
&#xD;
          6. Subjects with clinically significant pre-existing neurological comorbidities that are&#xD;
             unrelated to the contusion being treated (e.g. MS, ALS, significant prior peripheral&#xD;
             nerve dysfunction, residual problems related to previous spine-related neurological&#xD;
             pathologies) will be excluded only if it is felt that these preexisting morbidities&#xD;
             will increase risk, affect safety monitoring, or confound study results&#xD;
&#xD;
          7. Spinal cord injury associated with significant traumatic brain injury or coma that, in&#xD;
             the opinion of the Investigator, would preclude adequate assessment of spinal cord&#xD;
             function, brain injury that could be associated on its own with sensory or motor&#xD;
             deficits, or subjects with any other reason that results in an unreliable ISNCSCI exam&#xD;
&#xD;
          8. Subjects with clinically significant pre-existing respiratory disease not related to&#xD;
             the contusion being treated (e.g., COPD)&#xD;
&#xD;
          9. Subjects requiring long-term ongoing mechanical ventilation&#xD;
&#xD;
         10. Subjects with documented immune deficiency disorders, including a known diagnosis of&#xD;
             HIV infection/AIDS&#xD;
&#xD;
         11. Recent (according to DSM IV or DSM V criteria) history of abuse of narcotics or other&#xD;
             significant substance abuse&#xD;
&#xD;
         12. Significant injury complications where, in the view of the Investigator, participation&#xD;
             in the study could further complicate subject care, limit study follow-up, or confound&#xD;
             interpretation of safety or efficacy data.&#xD;
&#xD;
         13. A female who is:&#xD;
&#xD;
               -  Pregnant, or planning to become pregnant within the next 12-months; or&#xD;
&#xD;
               -  Breastfeeding; or&#xD;
&#xD;
               -  A woman of child-bearing potential (defined as post menarche and biologically&#xD;
                  capable of becoming pregnant [i.e., not surgically sterile]) who is engaged in&#xD;
                  active heterosexual relations and is not willing to use a barrier or hormonal&#xD;
                  form of birth control for 12-months following open spine surgery (e.g., oral,&#xD;
                  injected, or implanted contraceptives)&#xD;
&#xD;
         14. A male who is engaged in active heterosexual relations and is not willing to use birth&#xD;
             control for 3-months following open spine surgery including sperm donation or banking&#xD;
&#xD;
         15. Current or impending incarceration&#xD;
&#xD;
         16. Complete spinal cord transection as determined by screening MRI&#xD;
&#xD;
         17. Subjects with spinal cord injuries directly due to gunshot, knife, or other&#xD;
             penetrating wounds.&#xD;
&#xD;
         18. Known hypersensitivity to PLGA or PLL (e.g., hypersensitivity to absorbable sutures&#xD;
             containing PLGA)&#xD;
&#xD;
         19. History of severe mental illness (according to DSM IV or V)&#xD;
&#xD;
         20. Evidence of pre-trauma active local or systemic infection&#xD;
&#xD;
         21. Participation in another interventional clinical trial for six months after open spine&#xD;
             surgery&#xD;
&#xD;
         22. BMI over 39&#xD;
&#xD;
         23. Having a medical condition (e.g., cardiovascular disease, life threatening injuries),&#xD;
             or receiving medical treatment, or having any other reason that, in the judgment of&#xD;
             the Investigator, precludes successful participation and follow-up for at least six&#xD;
             months or confounds collection or interpretation of study safety, feasibility, or&#xD;
             efficacy data&#xD;
&#xD;
         24. Subjects receiving tetracyclines, such as minocycline (subjects must discontinue&#xD;
             tetracyclines to be enrolled in the study; tetracyclines can be resumed after 6 months&#xD;
             post-open spine surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Memorial Hospital Central</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida Health Neurosurgery</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Center for Spine Surgery</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elmhurst Hospital Center</name>
      <address>
        <city>Elmhurst</city>
        <state>New York</state>
        <zip>11373</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vidant Medical Center</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn Presbyterian Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center-Presbyterian</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>June 2, 2022</last_update_submitted>
  <last_update_submitted_qc>June 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Spinal Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03762655
org study id: InVivo-100-105
nct id: NCT03762655
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: Single (Participant)
masking 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. The subjects will be blinded to their study arm for the duration of the study.
measure: Change in AIS grade of one or more levels
time frame: 6 months post-implant
description: The proportion of subjects with an improvement of at least one AIS grade will be presented for each study arm.
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations determine the ASIA Impairment Scale (AIS) grade.
measure: Change in Neurological Level of Injury (NLI)
time frame: 3-months, 6-months, 12-months, 24-months post-open spine surgery
description: The ISNCSCI examinations determine the the Neurological Level of Injury (NLI). The NLI refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided that there is normal (intact) sensory and motor function rostrally.
NLI will be summarized for each study arm at visits (pre-surgery, 3-months, 6-months, 12-months, 24-months). Observed values and change from the baseline will be presented for each study arm.The ISNCSCI exam performed within 8 hours prior to surgery (pre-surgery ISNCSCI) will be used as the baseline.
measure: Change in motor scores
time frame: 3-months, 6-months, 12-months, 24-months post-open spine surgery
description: A numerical summary score of motor function in each extremity determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination. This score can reflect the degree of neurological impairment associated with the SCI, with lower score indicating greater impairment. Score ranges from 0-25 for each extremity, with maximum scores of 50 for the upper limbs and 50 for the lower limbs.
Motor scores will be summarized for each study arm at visits (pre-surgery, 3-months, 6-months, 12-months, 24-months). Observed values and change from the baseline will be presented for each study arm.The ISNCSCI exam performed within 8 hours prior to surgery (pre-surgery ISNCSCI) will be used as the baseline.
measure: Change in sensory scores
time frame: 3-months, 6-months, 12-months, 24-months post-open spine surgery
description: A numerical summary score of sensory function in each determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination. This score can reflect the degree of neurological impairment associated with the SCI, with lower score indicating greater impairment. Score ranges from 0-56 points each for light touch and pin prick (sharp/dull discrimination) modalities, with a maximum total score of 112 points per side of the body.
Observed values and change from the baseline will be presented for each study arm.The ISNCSCI exam performed within 8 hours prior to surgery (pre-surgery ISNCSCI) will be used as the baseline.
measure: Changes in bladder, bowel, and sexual function
time frame: 6-months, 12-months and 24-months, post-open spine surgery
description: Bladder, bowel and sexual function will be assessed using the Lower Urinary Tract, Bowel and Sexual Function System/Organ section of the ASIA Autonomic Standards Assessment Form. The Autonomic Standards Assessment Form has three questions in each category (Lower Urinary Tract or bladder, Bowel, Sexual Function) and each question is scored on a scale from 0 (complete loss of control) - 2 (normal function). Observed values and change from baseline will be presented for each study arm. The hospital discharge visit will be used as the baseline visit.
measure: Changes in spinal cord dimension
time frame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
description: Spinal cord dimensions (above, at, and below level of injury) will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.
measure: Changes in spinal cord lesion size
time frame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
description: Lesion size (in mm) will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.
measure: Changes in spinal cord lesion location
time frame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
description: Lesion Location will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.
measure: Changes in spinal cord anatomy-Presence of cyst
time frame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
description: Cyst presence or absence will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.
measure: Changes in cyst size, if present
time frame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
description: Cyst size, if present, will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.
measure: Changes in cyst location, if present
time frame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
description: Cyst location, if present, will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.
arm group label: Neuro-Spinal Scaffold Arm
arm group type: Experimental
description: Subjects in the Scaffold Arm will have the Scaffold implantation immediately following standard of care open spine surgery.
arm group label: Comparator Arm
arm group type: No Intervention
description: Subjects in the Comparator Arm will have standard of care open spine surgery and will not receive the Scaffold.
intervention type: Device
intervention name: Neuro-Spinal Scaffold
description: The investigational product ("Neuro-Spinal ScaffoldTM" or "Scaffold") is a porous bioresorbable polymer scaffold comprised of a synthetic biomaterial, poly(lactic-co-glycolic acid)-b-poly(L-lysine) (PLGA-PLL). The Scaffold is cylindrical in shape (3 mm diameter) and is available is three lengths (6 mm, 8 mm, 10 mm) for optimal fit in the intraspinal lesion cavity.
Based upon pre-clinical testing, the Scaffold is expected to be resorbed from the site of implant within 4 to 8 weeks.
arm group label: Neuro-Spinal Scaffold Arm
criteria: 
gender: All
minimum age: 16 Years
maximum age: 70 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
mesh term: Spinal Injuries