Intra-Articular Allocetra in Patients With Primary Knee Osteoarthritis

Inclusion criteria

• Participants must meet all of the inclusion criteria listed below to be eligible for the study:
• Age 64 years or above.
• Diagnosis of primary femorotibial knee OA.
• Radiographic evidence of knee OA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the index knee.
• Participants who are intolerant to, or have failed to adequately respond to at least 2 OA therapies.
• Index knee pain assessed during the screening period and following wash-out of pain medications.
• Willingness to abstain from prohibited medications/treatments during the trial.
• Women who are postmenopausal (≥12 months natural amenorrhea without alternative cause) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• Male participants with partners of childbearing potential, who are not surgically sterile (vasectomy) for at least 6 months prior to randomization, must use condoms with spermicide in addition to their partner's contraception from randomization and for 90 days after last dose.

Exclusion criteria

• Participants will be excluded from the study if they meet any of the following criteria:
• Severe or end-stage osteoarthritis of the index knee.
• Clinically significant structural abnormalities or instability of the index knee.
• Recent major injury, surgical procedure, or intra-articular treatment in the index knee.
• Any known history of infection or tumor of the index knee, or active infection at the intended injection site.
• Any known history of inflammatory arthropathy or crystal-deposition disease.
• Any severe systemic cartilage, bone, or musculoskeletal disorder that may interfere with study outcomes.
• Clinically significant widespread pain syndromes.
• Immunosuppressive therapy, clinically significant immunodeficiency, or active infection.
• Body Mass Index (BMI) \>40 kg/m²
• Use of medications that may interfere with pain assessment or study outcomes.
• Known coagulopathy or use of anticoagulant/antiaggregant medication.
• Significant uncontrolled systemic disease or clinically significant findings on screening laboratory tests or physical examination.