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A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects with Subacute Cervical Spinal Cord Injury

Description

The purpose of this study is to evaluate the safety of 3 sequential escalating doses of AST-OPC1 administered at a single time-point between 14 and 30 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).

Phase

Other

Inclusion and Exclusion 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-5 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 25 days following injury
  • Able to participate in an elective surgical procedure to inject AST-OPC1 14-30 days following SCI Major

  • 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

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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