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GRNOPC1 · 1 trial · 1 indication
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...
GRNOPC1 is an investigational therapy being studied for the treatment of spinal cord injury. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being developed by Lineage Cell Therapeutics, Inc., a biopharmaceutical company focused on cell-based therapies.
GRNOPC1 is being developed by Lineage Cell Therapeutics, Inc., a company traded on the stock exchange under the ticker symbol LCTX. The company is conducting clinical research on this investigational therapy for spinal cord injury, with the drug currently in Phase 1 development.
GRNOPC1 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The therapy is being studied for the treatment of spinal cord injury, and its clinical trial program is currently in the early stages of evaluating safety and tolerability.
GRNOPC1 has one completed clinical trial registered under NCT01217008, titled "Safety Study of GRNOPC1 in Spinal Cord Injury." This Phase 1 study enrolled 5 participants with spinal cord injury in the United States. The trial was uncontrolled, meaning there was no control group, and it was not randomized or double-blinded.
GRNOPC1 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for spinal cord injury. The therapy has completed one early-stage clinical trial, but it has not yet demonstrated sufficient safety and efficacy data to support regulatory approval.
GRNOPC1 is a monoclonal antibody therapy being developed for spinal cord injury. As a monoclonal antibody, it is designed to target specific molecules involved in the disease process. However, the specific molecular target of GRNOPC1 has not been disclosed in available clinical trial information.