drugset / Trial / NCT05835895
Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis
Phase 1
Active not recruiting
67 enrolled
Genascence Corporation
California Institute for Regenerative Medicine (CIRM) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this clinical study is to determine if a single injection of 1 or more dose levels of adeno-associated virus (AAV) gene therapy (GNSC-001) is safe and tolerated compared to placebo in participants with painful osteoarthritis (OA) of the knee.
Timeline
- Start
- 2023-06-12
- Primary completion
- 2025-04-08
- Completion
- 2029-05
Publications
- Evans CH, Ghivizzani SC, Robbins PD. Osteoarthritis Gene Therapy: A 30-Year Journey From Concept to Clinical Trials. J Orthop Res. 2026 Feb;44(2):e70141. doi: 10.1002/jor.70141.
- Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686.
- Evans CH, Ghivizzani SC, Robbins PD. The 2024 OREF Clinical Research Award: Progress Toward a Gene Therapy for Arthritis. J Am Acad Orthop Surg. 2024 Dec 1;32(23):1052-1060. doi: 10.5435/JAAOS-D-24-00831. Epub 2024 Oct 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GNSC-001 | Gene therapy (AAV / viral vector) | — | Other |