Pilot Study of the Neuro-Spinal Scaffold for the Treatment of AIS A Cervical Acute SCI

Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal Scaffold for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5 - T1 Neurological Levels

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03105882

Enrollment

Registered

2017-04-10

Start date

2017-03-30

Completion date

2018-03-15

Last updated

2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Cervical Acute Spinal Cord Injury

Keywords

Spinal Cord Injury, SCI, Complete (AIS A) Traumatic Acute Spinal Cord Injury

Brief summary

Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological Levels The purpose of this study is to support an expansion to support marketing applications as well as future studies.

Interventions

DEVICENeuro-Spinal Scaffold

Experimental: Neuro-Spinal Scaffold

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 16-70 years of age, inclusive * AIS A classification of traumatic spinal cord injury with a neurological level within C5-T1 inclusive * Recent injury * Non-penetrating SCI

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) * No identifiable intra-spinal cavity following myelotomy/irrigation in the contused spinal cord in which a Scaffold can be placed * Spinal cord injury associated with significant traumatic brain injury or coma that * Radiographic or visual evidence of parenchymal dissociation or anatomic transection as determined by the Investigator where the contusion completely bridges a full cross-section of the spinal cord * Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds

Design outcomes

Primary

Measure	Time frame
Incidence of all Adverse Device Effects of any kind/seriousness.	6 Months

Other

Measure	Time frame	Description
American Spinal Injury Association Impairment Scale (AIS) improvement of one or more grade	6 months	International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exams
Improvements in motor and sensory scores	6 months	ISNCSCI exams
Improvements in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)	6 months	GRASSP Assessment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026