Traumatic Cervical Acute Spinal Cord Injury Clinical Trial
Official title:
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
| Verified date | March 2018 |
| Source | InVivo Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | March 15, 2018 |
| Est. primary completion date | March 15, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Toronto Western Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| InVivo Therapeutics |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | American Spinal Injury Association Impairment Scale (AIS) improvement of one or more grade | International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exams | 6 months | |
| Other | Improvements in motor and sensory scores | ISNCSCI exams | 6 months | |
| Other | Improvements in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) | GRASSP Assessment | 6 months | |
| Primary | Incidence of all Adverse Device Effects of any kind/seriousness. | 6 Months |