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Polymer Scaffold
Neuro-Spinal Scaffold for Spinal Cord Injury
N/A
Waitlist Available
Research Sponsored by InVivo Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-implantation
Awards & highlights
Study Summary
This trial will evaluate the safety and probable benefit of a Scaffold in subjects with a certain type of spinal cord injury.
Who is the study for?
This trial is for individuals aged 16-70 with a recent (within 7 days) traumatic spinal cord injury at T2-T12 levels, classified as AIS A. They must require and be suitable for open spine surgery, have a stable health condition, and consent to participate. Excluded are those with incomplete SCI, multiple injuries, significant brain injury or coma, pre-existing neurological or respiratory diseases unrelated to the injury, immune deficiencies like HIV/AIDS, substance abuse issues, pregnancy or unwillingness to use birth control post-surgery.Check my eligibility
What is being tested?
The INSPIRE Study tests the safety and potential benefit of implanting a Neuro-Spinal Scaffold in patients with thoracic AIS A traumatic spinal cord injuries. The Scaffold is made from poly(lactic-co-glycolic acid)-b-poly(L-lysine). This single-arm study does not randomize participants but evaluates all who receive the intervention.See study design
What are the potential side effects?
Potential side effects may include reactions related to scaffold implantation such as inflammation at the site of surgery, infection risks due to compromised immunity around the injured area and general surgical risks including bleeding and adverse reactions to anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Patients With Improvement in AIS Grade of One or More Levels
Secondary outcome measures
Change From Baseline in ISNCSCI Total Motor Score
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Neuro-Spinal ScaffoldExperimental Treatment1 Intervention
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
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Who is running the clinical trial?
InVivo TherapeuticsLead Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled
Richard Toselli, MDStudy DirectorInVivo Therapeutics Corporation
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any type of incomplete spinal cord injury.You have had more than one separate spinal cord injury.There should not be any open spaces in the damaged spinal cord where the Scaffold can be placed.Your doctor can see clear and strong signals from your nerves at the injury site before the implant is put in.You have existing neurological conditions that could make the study risky or affect the accuracy of the results.You have a spinal cord injury along with a serious head injury or coma that may make it difficult to assess your spinal cord function.You have a serious lung disease that is not related to the injury being treated.You are allergic to poly(lactic-co-glycolic acid) (PLGA) or poly-L-lysine (PLL).You need to have spinal surgery to reach the injured spinal cord, either from the back or from the front and back.You need to use a breathing machine for a long time.You have a known immune deficiency disorder, such as HIV/AIDS.You have recently abused drugs or alcohol.You have a complete spinal cord injury.You have a spinal cord injury caused by a gunshot, knife, or similar type of injury.You have a history of serious mental illness according to the DSM IV or V.You have an infection just before the injury.You have a specific type of spinal cord injury at a certain level, as confirmed by a qualified medical professional.You have a spinal cord injury from a blow or impact that is at least 4 millimeters wide as shown on an MRI.Your body mass index (BMI) is higher than 39.You must be between 16 and 70 years old to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Neuro-Spinal Scaffold
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any individuals beyond the age of twenty-five being considered for enrollment in this clinical trial?
"This research is looking for patients who are between 16 and 70 years old."
Answered by AI
Are individuals currently being accepted for enrollment in this test?
"Unfortunately, the clinical trial has ceased recruiting. Initially posted on October 13th 2014 and last updated November 19th 2021, this study is no longer taking patients. Nevertheless, there are 904 other trials in need of participants at present."
Answered by AI
Is this clinical trial being administered in more than one location within the state?
"This clinical trial has 8 recruitment sites, including but not limited to Oregon Health & Science University in Portland, Allegheny General Hospital in Pittsburgh and Vidant Medical Center in Greenville."
Answered by AI
What criteria must be met for someone to participate in this medical investigation?
"This clinical trial is recruiting 20 individuals aged 16 to 70 with non-penetrating spinal cord injuries that measure at least 4 millimeters in diameter. Qualified medical professionals must confirm the AIS A classification of traumatic injury, which occurred no longer than seven days prior. Furthermore, hemodynamic stability and eligibility for open spine surgery are necessary criteria before informed consent can be obtained from participants."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Carolina NeuroSurgery and Spine Associates/Carolinas Rehabilitation
Vidant Medical Center
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am a 53-year-old white male. On September 18, 2023 I had an accident, I fell from a tree I was working in, fractured my back in 2 places, and sustained a significant spinal cord injury from a bone fragment compressing on my spinal cord. In addition, I broke 9 ribs and punctured a lung.
I very much want to regain the ability to walk. I do have some movement in my legs and some sensation of feeling in my legs. My upper body is strong and was not affected by the injury.
I live 10 miles south of Winston-Salem NC.
I am self employed so my schedule can be flexible. Additionally I am well educated; I have one masters and two bachelor degrees. I am very comfortable in a clinical setting and I have an understanding of testing. I am willing to turn over all medical information from other providers if I am selected for a trial.
I look forward to hearing from you and discussing the next steps.
PatientReceived 1 prior treatment
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