CONDITION

Knee osteoarthritis is a degenerative disease driven by physical breakdown of the joint cartilage, together with a chronic inflammation within the knee space. Over time, many patients will develop worsening pain in the joint and functional impairment, which may ultimately require knee replacement.

This study is assessing the safety and efficacy of Allocetra™ in patients suffering from painful knee osteoarthritis.

ASSESSMENTS

Change in knee pain and function.

INCLUSION AND EXCLUSION CRITERIA
Inclusion Criteria:
  1. Age 64 years or above.
  2. Participants diagnosed with primary knee OA with symptoms for at least 3 months, who have failed to adequately respond adequately to prior knee OA therapies.
  3. Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
Exclusion Criteria:
  1. Any other disorder in the index knee: current or prior tumor, intra-articular or bone infection, recent ligamentous repair or malalignment correction, recent major injury such as torn ligament, torn meniscus, or severe sprain, recent surgical cartilage, ligament, bone or meniscal procedure, large knee effusion, clinically relevant knee instability, severe hip osteoarthritis.
  2. Recent intra-articular injected therapy
  3. Any exclusionary systemic condition: inflammatory arthropathy or crystal-deposition arthropathy, severe systemic cartilage and/or bone disorder such as chondrodysplasia, osteogenesis imperfecta, clinically significant widespread pain syndromes, e.g., fibromyalgia, long COVID syndrome, wheelchair bound, immunosuppressive therapy, active infection, certain tumors, pregnancy, uncontrolled diabetes or hypertension, severe cardiac, respiratory or hematologic diseases as defined in the protocol.
  4. Body Mass Index (BMI) >40