Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

Major Inclusion Criteria:

- Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3

- Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5

- Last fully preserved single neurological level (SNL) from C-4 to C-7

- From 18 through 69 years of age at time of injury

- Single spinal cord lesion on a post-stabilization magnetic resonance imaging (MRI)
scan, with sufficient visualization of the spinal cord injury epicenter and lesion
margins to enable post-injection safety monitoring

- 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 37 days
following injury

- Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days
following SCI

Major Exclusion Criteria:

- SCI due to penetrating trauma

- Traumatic anatomical transection or laceration of the spinal cord based on prior
surgery or MRI

- Any concomitant injury that interferes with the performance, interpretation or
validity of neurological examinations

- Inability to communicate effectively with neurological examiner such that the validity
of patient data could be compromised

- Significant organ damage or systemic disease that would create an unacceptable risk
for surgery or immunosuppression

- History of any malignancy (except non-melanoma skin cancers)

- Pregnant or nursing women

- Body mass index (BMI) > 35 or weight > 300 lbs.

- Active participation in another experimental procedure/intervention