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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01217008 | Safety Study of GRNOPC1 in Spinal Cord Injury | PHASE1 | COMPLETED | 5 | — | — | Oct 1, 2010 | Jul 1, 2013 | Jun 18, 2020 | 7 | United States |
The primary endpoint is safety, as measured by the frequency and severity of adverse events within 1 year (365 days) of GRNOPC1 injection that are related to GRNOPC1, the injection procedure used to administer GRNOPC1, and/or the concomitant immunosuppression administered.
| Arm | Type | Description |
|---|---|---|
| GRNOPC1 | EXPERIMENTAL | Subjects who receive an injection of GRNOPC1 |
| Name | Type | Description |
|---|---|---|
| GRNOPC1 | BIOLOGICAL | One injection of 2 million GRNOPC1 cells. |
Major Inclusion Criteria: * Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation \< 5 levels * Last fully preserved neurological level from T-3 through T-11 * From 18 through 65 years of age at time of injury * Single spinal cord lesion * Informed consent f...