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Outcome Measures

Primary Outcomes (1)

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.
6 months post-implant

Secondary Outcomes (10)

Change in Neurological Level of Injury (NLI)
3-months, 6-months, 12-months, 24-months post-open spine surgery
Change in motor scores
3-months, 6-months, 12-months, 24-months post-open spine surgery
Change in sensory scores
3-months, 6-months, 12-months, 24-months post-open spine surgery
Changes in bladder, bowel, and sexual function
6-months, 12-months and 24-months, post-open spine surgery
Changes in spinal cord dimension
72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
+5 more secondary outcomes

Study Arms (2)

Neuro-Spinal Scaffold Arm

EXPERIMENTAL

Subjects in the Scaffold Arm will have the Scaffold implantation immediately following standard of care open spine surgery.

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.

Interventions

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.

Neuro-Spinal Scaffold Arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age16 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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)

Study Sites (16)

UC Davis Medical Center

Sacramento, California, 95817, United States

University of California San Diego

San Diego, California, 92103, United States

University of Colorado Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

University of South Florida Health Neurosurgery

Tampa, Florida, 33613, United States

University of Iowa

Iowa City, Iowa, 52242, United States

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Rutgers Center for Spine Surgery

Related Publications (1)

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.

PMID: 39471088DERIVED

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

PARTICIPANT

Masking Details

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.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: 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.

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

Study Stopped

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 Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Neuro-Spinal Scaffold Arm

Comparator Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Neuro-Spinal Scaffold Arm

Comparator Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations