Trial Search Results

Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Lineage Cell Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: AST-OPC1

Phase:

Phase 1/Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - 69 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
David Cutler
408-885-2100
Recruiting