search
Back to results

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 (INSPIRE 2)

Primary Purpose

Injury, Spinal Cord

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuro-Spinal Scaffold
Sponsored by
InVivo Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injury, Spinal Cord

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis Medical Center
  • University of California San Diego
  • University of Colorado Memorial Hospital Central
  • University of South Florida Health Neurosurgery
  • University of Iowa
  • University of Maryland Medical Center
  • Rutgers Center for Spine Surgery
  • Elmhurst Hospital Center
  • Icahn School of Medicine at Mount Sinai
  • Vidant Medical Center
  • Penn Presbyterian Medical Center
  • Thomas Jefferson University
  • University of Pittsburgh Medical Center-Presbyterian
  • Rhode Island Hospital
  • University of Texas Health San Antonio
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Neuro-Spinal Scaffold Arm

Comparator Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in AIS grade of one or more levels
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.

Secondary Outcome Measures

Change in Neurological Level of Injury (NLI)
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.
Change in motor scores
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.
Change in sensory scores
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.
Changes in bladder, bowel, and sexual function
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.
Changes in spinal cord dimension
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.
Changes in spinal cord lesion size
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.
Changes in spinal cord lesion location
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.
Changes in spinal cord anatomy-Presence of cyst
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.
Changes in cyst size, if present
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.
Changes in cyst location, if present
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.

Full Information

First Posted
November 29, 2018
Last Updated
June 2, 2022
Sponsor
InVivo Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT03762655
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
Acronym
INSPIRE 2
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InVivo Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury, Spinal Cord

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuro-Spinal Scaffold Arm
Arm Type
Experimental
Arm Description
Subjects in the Scaffold Arm will have the Scaffold implantation immediately following standard of care open spine surgery.
Arm Title
Comparator Arm
Arm Type
No Intervention
Arm 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(s)
Neuro-Spinal Scaffold
Intervention 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.
Primary Outcome Measure Information:
Title
Change in AIS grade of one or more levels
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.
Time Frame
6 months post-implant
Secondary Outcome Measure Information:
Title
Change in Neurological Level of Injury (NLI)
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.
Time Frame
3-months, 6-months, 12-months, 24-months post-open spine surgery
Title
Change in motor scores
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.
Time Frame
3-months, 6-months, 12-months, 24-months post-open spine surgery
Title
Change in sensory scores
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.
Time Frame
3-months, 6-months, 12-months, 24-months post-open spine surgery
Title
Changes in bladder, bowel, and sexual function
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.
Time Frame
6-months, 12-months and 24-months, post-open spine surgery
Title
Changes in spinal cord dimension
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.
Time Frame
72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Title
Changes in spinal cord lesion size
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.
Time Frame
72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Title
Changes in spinal cord lesion location
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.
Time Frame
72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Title
Changes in spinal cord anatomy-Presence of cyst
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.
Time Frame
72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Title
Changes in cyst size, if present
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.
Time Frame
72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Title
Changes in cyst location, if present
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.
Time Frame
72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of Colorado Memorial Hospital Central
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
University of South Florida Health Neurosurgery
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Rutgers Center for Spine Surgery
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
Facility Name
Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center-Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of Texas Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs