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Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
Recruiting
I'm InterestedTrial ID: NCT02302157
Purpose
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).
Official Title
A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury
Stanford Investigator(s)
Gary K. Steinberg, MD, PhD
Bernard and Ronni Lacroute-William Randolph Hearst Professor of Neurosurgery and Neurosciences and Professor, by courtesy, of Neurology
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
Intervention(s):
biological: AST-OPC1
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
David Cutler
408-885-2100