drugset / Trial / NCT06690710

FiH Safety and Feasibility Study Assessing Intra-articular Administration of aeGF in Patients With Knee Osteoarthritis

NCT06690710 ↗

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

EvaluationDrugModalityDoseRoute
Subject allogeneic engineered Gingival Fibroblasts Cell therapy 5e+07 cells —

Indications