Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
Trial ID or NCT#
NCT02302157
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: 18 Years to 69 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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
Investigator(s)
Gary K. Steinberg, MD, PhD
Cerebrovascular neurosurgeon,
Moyamoya surgeon,
Aneurysm neurosurgeon,
Neurosurgeon,
Neurosurgeon
Bernard and Ronni Lacroute-William Randolph Hearst Professor of Neurosurgery and Neurosciences and Professor, by courtesy, of Neurology and Neurological Sciences
Contact us to find out if this trial is right for you.
Contact
David Cutler
408-885-2100
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