Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02302157 | Dose Escalation Study of AST-OPC1 in Spinal Cord Injury | PHASE1 | COMPLETED | 25 | — | — | Mar 1, 2015 | Dec 1, 2018 | Jul 14, 2021 | 9 | United States |
Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection
| Arm | Type | Description |
|---|---|---|
| AST-OPC1 | EXPERIMENTAL | Open label, dose escalation, cross-sequential cohort of subjects who receive an injection or two injections of AST-OPC1 at a single time-point |
| Name | Type | Description |
|---|---|---|
| AST-OPC1 | BIOLOGICAL | One injection of 2 million or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent |
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...