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

InVivo Therapeutics

Status: Withdrawn

Conditions: Traumatic Cervical Acute Spinal Cord Injury

Treatments: Device: Neuro-Spinal Scaffold

Study type: Interventional

Funder types: Industry

Identifiers

NCT03105882

InVivo-100-102

Details and patient eligibility

About

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.

Sex: All

Ages: 16 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Neuro-Spinal Scaffold

Experimental group

Treatment:

Device: Neuro-Spinal Scaffold