Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

Trial ID or NCT#

NCT02302157

Status

recruiting iconRECRUITING

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: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Gary K. Steinberg, MD, PhD
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

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Contact

David Cutler
408-885-2100

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View on ClinicalTrials.gov