drugset / Trial / NCT06690710
FiH Safety and Feasibility Study Assessing Intra-articular Administration of aeGF in Patients With Knee Osteoarthritis
Phase 1
Recruiting
15 enrolled
Scarcell Therapeutics S.A.S.
Boston Imaging Core Lab · collabTFS Trial Form Support · collab
NaSingle-groupOpen-labelTreatment
Summary
The company funding this study has developed an advanced therapy medicinal product (a cell therapy) from human donor cells which it wants to assess as a possible treatment for knee osteoarthritis (OA). Tissue from the gums of a human donor is used to make the study drug called allogeneic engineered Gingival Fibroblasts (aeGF). The purpose of this study is to evaluate the safety of a single injection of aeGF in the knee joint of participants with OA. aeGF have shown anti-inflammatory effects, pain relief and cartilage regeneration in animals and so are now being investigated as a treatment for OA in humans.
Timeline
- Start
- 2025-08-14
- Primary completion
- 2027-02-01
- Completion
- 2028-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | allogeneic engineered Gingival Fibroblasts | Cell therapy | 5e+07 cells | — |