Phase 2
N=25
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
Cervical Spinal Cord Injury · Spine Injury · Spinal Cord Trauma
Bottom Line
View on ClinicalTrials.gov: NCT02302157 ↗Enrolled (actual)
25
Serious AEs
44.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection — 92; 122; 133; 118 Adverse Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AST-OPC1 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lineage Cell Therapeutics, Inc.
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection |
92; 122; 133; 118; 69 | — |
| SECONDARY 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 |
19; 21; 17; 22; 18; 24 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02302157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.