The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury

NCT ID: NCT02138110

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-13
• Study Completion Date: 2023-12-31

Brief Summary

This is an HDE probable benefit, open-label, non- randomized, single-arm, multicenter 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.

Detailed Description

This is an HDE probable benefit, open-label, non-randomized, single-arm, multicenter 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.

The study will be conducted by qualified Investigators who have been trained on the surgical Scaffold implant procedure in order to enroll subjects in the Primary Endpoint Analysis Set, defined as all subjects with a successful Scaffold implant, no major protocol deviations, and a complete 6-month Primary Endpoint Follow-up Visit. After receiving the Scaffold and following discharge, subjects will participate in a comprehensive rehabilitation program. For the first 24-months after implantation of the Scaffold, Follow-up and Long-term Follow-up assessments will be conducted at either the study site or the rehabilitation center. The Long-term Follow-up annual visits for years 3 through 10 will be conducted over the telephone.

Conditions

Traumatic Thoracic Acute Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neuro-Spinal Scaffold

Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery

Group Type: EXPERIMENTAL

Neuro-Spinal Scaffold

Intervention Type: DEVICE

Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery

Interventions

Neuro-Spinal Scaffold

Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Subjects must meet all of the following to be considered eligible:

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 receive Scaffold within 7 days from injury)

3. Non-penetrating SCI (contusion injury) that is no less than approximately 4 mm in diameter by MRI

4. 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)

5. Informed consent obtained

6. 16-70 years of age, inclusive

7. Hemodynamically stable and deemed a suitable candidate for surgery

Exclusion Criteria

Subjects who meet any of the following will be excluded:

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 (contusion) will be excluded.

4. No discrete cavity (existing or created by irrigation/myelotomy) 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 before Scaffold implantation (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., multiple sclerosis, amyotrophic lateral sclerosis, 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 International Standards of Neurological Classification of Spinal Cord Injury (ISNCSCI) exam

8. Subjects with clinically significant pre-existing respiratory disease not related to the contusion being treated (e.g., chronic obstructive pulmonary disorder)

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 Diagnostic and Statistical Manual of Mental Disorders (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 Scaffold implantation (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 Scaffold implantation including sperm donation or banking

15. Current or impending incarceration

16. Complete spinal cord transection

17. Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds.

18. Known hypersensitivity to poly(lactic-co-glycolic acid) (PLGA) or poly-L-lysine (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 Scaffold implantation

22. Body mass index (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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InVivo Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Toselli, MD

Role: STUDY_DIRECTOR

InVivo Therapeutics Corporation

Locations

Barrow Neurological Institute - St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

USC/Keck School of Medicine

Los Angeles, California, United States

University of California/Davis Medical Center

Sacramento, California, United States

Cooper Neurological Institute

Camden, New Jersey, United States

Carolina NeuroSurgery and Spine Associates/Carolinas Rehabilitation

Charlotte, North Carolina, United States

Vidant Medical Center

Greenville, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Harrop JS, Kim KD, Okonkwo DO, Goldstein IM, Lee KS, Toselli RM. Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: A Randomized Controlled Trial (INSPIRE 2.0). Neurosurgery. 2025 Apr 1;96(4):751-762. doi: 10.1227/neu.0000000000003180. Epub 2024 Oct 8.

Reference Type: DERIVED

PMID: 39471088 (View on PubMed)

Kim KD, Lee KS, Coric D, Harrop JS, Theodore N, Toselli RM. Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: 24-Month Follow-up From the INSPIRE Study. Neurosurgery. 2022 Jun 1;90(6):668-675. doi: 10.1227/neu.0000000000001932. Epub 2022 Apr 22.

Reference Type: DERIVED

PMID: 35442254 (View on PubMed)

Kim KD, Lee KS, Coric D, Chang JJ, Harrop JS, Theodore N, Toselli RM. A study of probable benefit of a bioresorbable polymer scaffold for safety and neurological recovery in patients with complete thoracic spinal cord injury: 6-month results from the INSPIRE study. J Neurosurg Spine. 2021 Feb 5;34(5):808-817. doi: 10.3171/2020.8.SPINE191507. Print 2021 May 1.

Reference Type: DERIVED

PMID: 33545674 (View on PubMed)

Theodore N, Hlubek R, Danielson J, Neff K, Vaickus L, Ulich TR, Ropper AE. First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury: A Clinical Pilot Study for Safety and Feasibility. Neurosurgery. 2016 Aug;79(2):E305-12. doi: 10.1227/NEU.0000000000001283.

Reference Type: DERIVED

PMID: 27309344 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

InVivo-100-101

Identifier Type: -

Identifier Source: org_study_id