Safety Study of GRNOPC1 in Spinal Cord Injury

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).

Official Title
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A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Biological: GRNOPC1


Participation Criteria
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Eligibility Criteria
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Major Inclusion Criteria: Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation < 5 levels Last fully preserved neurological level from T-3 through T-11 From 18 through 65 years of age at time of injury Single spinal cord lesion Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 11 days following injury Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI Major Exclusion Criteria: SCI due to penetrating trauma Traumatic anatomical transection or laceration of the spinal cord Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations Inability to communicate effectively with neurological examiner Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression History of any malignancy Pregnant or nursing women Body mass index (BMI) > 35 or weight > 300 lbs. Active participation in another experimental procedure/intervention

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GRNOPC1<br>Subjects who receive an injection of GRNOPC1 | Biological: GRNOPC1<br>* One injection of 2 million GRNOPC1 cells.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The primary endpoint is safety, as measured by the frequency and severity of adverse events within 1 year (365 days) of GRNOPC1 injection that are related to GRNOPC1, the injection procedure used to administer GRNOPC1, and/or the concomitant immunosuppression administered. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological function | The secondary endpoint is neurological function as measured by sensory scores and lower extremity motor scores on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury, GRNOPC1