First-in-human Study to Assess the Safety and Feasibility of Intra-articular Administration of Allogeneic Engineered Gingival Fibroblasts (aeGF) in Patients With Knee Osteoarthritis
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.
• Willing and able to provide informed consent;
• Male or female participants aged ≥40 years;
• Evidence of OA in the medial tibiofemoral joint (MTJ) as follows:
‣ Clinical - knee pain;
⁃ Radiological - Kellgren-Lawrence:
• Grade 2 - definite osteophytes, possible joint space narrowing (JSN), or;
∙ Grade 3 - moderate osteophytes, definite JSN, some sclerosis, possible bone-end deformity (Altman et al., 1986; Kellgren et al., 1957; Kohn et al., 2016).
∙ Minimal joint space width (JSW) of 2.5 mm on knee X-ray (OARSI 1 or 2);
• Score ≥3 on visual analogue scale (VAS) (0-10 range) for pain at Screening.