NCT02302157CompletedPhase 1
A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury
Lineage Cell Therapeutics, Inc.17 sites in 1 country25 target enrollmentStarted: March 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 25
- Locations
- 17
- Primary Endpoint
- Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Outcomes
Primary Outcomes
Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection
Time Frame: One Year
Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection
Secondary Outcomes
- Neurological Function as Measured by Upper Extremity Motor Scores and Motor Level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examinations as Secondary End Point - 365 Days After Injection of AST-OPC1(One Year)
Investigators
Study Sites (17)
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