Injury, Spinal CordINSPIRE 2NCT03762655
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
A study testing Neuro-Spinal Scaffold in people with Injury, Spinal Cord, run by InVivo Therapeutics at 16 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Injury, Spinal Cord
- What is being tested?
- Neuro-Spinal Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 16 sitesUnited States
- Study dates
- 21 May 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Colorado Memorial Hospital Central
Colorado Springs, Colorado, 80909
Elmhurst Hospital Center
Elmhurst, New York, 11373
Vidant Medical Center
Greenville, North Carolina, 27834
University of Iowa
Iowa City, Iowa, 52242
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Icahn School of Medicine at Mount Sinai
New York, New York, 10003
Rutgers Center for Spine Surgery
Newark, New Jersey, 07101
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center-Presbyterian
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
UC Davis Medical Center
Sacramento, California, 95817
University of Texas Health San Antonio
San Antonio, Texas, 78229
University of California San Diego
San Diego, California, 92103
University of South Florida Health Neurosurgery
Tampa, Florida, 33613
About this study
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
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.
Read the 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.
- Conditions
- Injury, Spinal Cord
- Being tested
- Neuro-Spinal Scaffold
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-Spinal ScaffoldDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuro-Spinal Scaffold Arm | Experimental | Subjects in the Scaffold Arm will have the Scaffold implantation immediately following standard of care open spine surgery. Receives: Device: Neuro-Spinal Scaffold |
| Comparator Arm | No intervention | Subjects in the Comparator Arm will have standard of care open spine surgery and will not receive the Scaffold. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-implant
Secondary outcomes (10)
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.
Measured: 3-months, 6-months, 12-months, 24-months post-open spine surgery
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.
Measured: 3-months, 6-months, 12-months, 24-months post-open spine surgery
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.
Measured: 3-months, 6-months, 12-months, 24-months post-open spine surgery
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.
Measured: 6-months, 12-months and 24-months, post-open spine surgery
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.
Measured: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
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.
Measured: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
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.
Measured: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
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.
Measured: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
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.
Measured: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
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.
Measured: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start21 May 2019
- Primary completion9 Mar 2023
- Study completion31 Dec 2023
Why it stopped: Primary Endpoint not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury, Spinal CordStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- InVivo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762655
- Sponsor's protocol ID
- InVivo-100-105
- Acronym
- INSPIRE 2
- Status last verified
- Jun 2022
- First submitted
- 29 Nov 2018
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 39471088
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03762655
- Acronym / sponsor ID
- INSPIRE 2 / InVivo-100-105
- Conditions
- Injury, Spinal Cord
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary Endpoint not met
- Enrolment
- 20 participants (actual)
- Lead sponsor
- InVivo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 May 2019 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neuro-Spinal Scaffold Arm | Experimental | Device: Neuro-Spinal ScaffoldSubjects in the Scaffold Arm will have the Scaffold implantation immediately following standard of care open spine surgery. |
| Comparator Arm | No intervention | –Subjects in the Comparator Arm will have standard of care open spine surgery and will not receive the Scaffold. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (27 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro-Spinal ScaffoldThe 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. | Device | Neuro-Spinal Scaffold Arm |
Primary outcome
Change in AIS grade of one or more levels
Time frame: 6 months post-implant
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.
10 secondary outcomes
Change in Neurological Level of Injury (NLI)
Time frame: 3-months, 6-months, 12-months, 24-months post-open spine surgery
Change in motor scores
Time frame: 3-months, 6-months, 12-months, 24-months post-open spine surgery
Change in sensory scores
Time frame: 3-months, 6-months, 12-months, 24-months post-open spine surgery
Changes in bladder, bowel, and sexual function
Time frame: 6-months, 12-months and 24-months, post-open spine surgery
Changes in spinal cord dimension
Time frame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Changes in spinal cord lesion size
Time frame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Changes in spinal cord lesion location
Time frame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
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
Changes in cyst size, if present
Time frame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Changes in cyst location, if present
Time frame: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Results and safety
The study was stopped early (reason given: Primary Endpoint not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 39471088Harrop 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-Spinal Scaffold in people with Injury, Spinal Cord, run by InVivo Therapeutics at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Primary Endpoint not met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AIS grade of one or more levels (time frame: 6 months post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03762655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.