drugset / Trial / NCT02302157
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2015-03
- Primary completion
- 2018-12
- Completion
- 2018-12
Publications
- Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6):812-820. doi: 10.3171/2022.5.SPINE22167. Print 2022 Dec 1.
- McKenna SL, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth E, Fessler RG. Ten-year safety of pluripotent stem cell transplantation in acute thoracic spinal cord injury. J Neurosurg Spine. 2022 Apr 1;37(3):321-330. doi: 10.3171/2021.12.SPINE21622. Print 2022 Sep 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AST-OPC1 | Cell therapy | 2 cells | Other |
| Subject | AST-OPC1 | Cell therapy | 10 cells | Other |
| Subject | AST-OPC1 | Cell therapy | 20 cells | Other |